RAC (Devices) Exam Preparation Flashcards
(249 cards)
1
Q
A
2
Q
What is a PMA (Premarket Approval)?
A
The most stringent device marketing application required for Class III devices that support or sustain human life or present potential unreasonable risk of illness or injury
3
Q
What is the difference between “clearance” and “approval” of medical devices?
A
510(k) devices receive clearance while PMA devices receive approval - PMA approval is essentially a private license granting permission to market the device
4
Q
What are the four main domains covered in the RAC-Devices exam?
A
The four main domains are: 1) Strategic Planning (29%) 2) Pre-marketing (25%) 3) Post-marketing (38%) and 4) Interfacing (8%)
5
Q
What is the regulatory basis of content for the RAC-Devices exam?
A
Content is based on 30% US FDA requirements; 30% European regulations/guidance from EC and competent authorities; and 40% globally applicable regulatory practices from IMDRF WHO and ISO
6
Q
What is the difference between product classification in the US and EU for medical devices?
A
In the US devices are classified into Class I II or III based on risk - In the EU devices are classified into Class I IIa IIb or III with additional subcategories in Class I for sterile and measuring devices
7
Q
What is a 510(k) submission?
A
A Premarket Notification submission to FDA demonstrating that a device is substantially equivalent to a legally marketed device not subject to PMA
8
Q
How do you determine substantial equivalence for a 510(k) submission?
A
A device is substantially equivalent if it has the same intended use and either the same technological characteristics as the predicate or different technological characteristics that don’t raise new safety/effectiveness questions
9
Q
What are the three types of 510(k) submissions?
A
Traditional 510(k); Special 510(k); and Abbreviated 510(k)
10
Q
What is a Special 510(k)?
A
A submission for a modification to a device that has been cleared under the 510(k) process where the manufacturer declares conformance to design controls without providing the data
11
Q
What is an Abbreviated 510(k)?
A
A submission that relies on the use of guidance documents special controls and recognized standards to expedite the review process
12
Q
What must be demonstrated for PMA approval?
A
The PMA must contain sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use
13
Q
What is an Investigational Device Exemption (IDE)?
A
An IDE allows an investigational device to be used in a clinical study to collect safety and effectiveness data most often in support of a PMA application
14
Q
What are the requirements for clinical evaluation of devices under an IDE?
A
Requirements include an investigational plan approved by an IRB (and FDA for significant risk devices); informed consent; labeling stating investigational use only; monitoring of the study; and maintaining required records
15
Q
What are Medical Device Reporting (MDR) requirements?
A
MDR requires manufacturers importers and device user facilities to report certain device-related adverse events and product problems to the FDA
16
Q
What is ISO 13485?
A
An internationally recognized standard for medical device quality management systems specifying requirements for a QMS to demonstrate ability to provide medical devices meeting customer and regulatory requirements
17
Q
What is the difference between ISO 13485:2016 and FDA 21 CFR Part 820?
A
ISO 13485:2016 has more explicit risk-based requirements enhanced documentation control and requirements for confidential health information - FDA Part 820 is law for US market while ISO 13485 is voluntary
18
Q
What is the Medical Device Regulation (MDR) in the EU?
A
The MDR (2017/745) is the regulation that replaced the Medical Device Directive imposing more stringent requirements for medical device approval and post-market surveillance in the European Union
19
Q
What are the key differences between the EU MDR and the MDD?
A
The MDR has expanded requirements including more rigorous clinical evaluation; increased documentation; stronger post-market surveillance; UDI requirements; transparent EUDAMED database; and designated person for regulatory compliance
20
Q
What are the General Safety and Performance Requirements (GSPRs) in the EU MDR?
A
The GSPRs are the requirements (previously called Essential Requirements in MDD) that all medical devices must meet regarding safety and performance throughout design manufacturing and clinical use
21
Q
What is a Notified Body?
A
An organization designated by an EU country to assess the conformity of certain products before being placed on the market performing tasks related to conformity assessment procedures
22
Q
What is CE marking?
A
A marking that indicates a product’s conformity with EU health safety and environmental protection standards allowing the free movement of products within the European market
23
Q
What is a Technical File for medical devices?
A
A comprehensive set of documentation that demonstrates a device’s compliance with regulatory requirements including design specifications risk analysis testing clinical data and labeling information
24
Q
What is a Design History File (DHF)?
A
A compilation of records containing the complete design and development history of a medical device as required by FDA’s Quality System Regulation
25
What is a Device Master Record (DMR)?
A compilation of records containing the procedures and specifications for a finished device as required by FDA's Quality System Regulation
26
What is a Device History Record (DHR)?
A compilation of records containing the production history of a finished device including manufacturing testing and quality control data
27
What are the key elements of design controls for medical devices?
Design controls include design and development planning; design input; design output; design review; design verification; design validation; design transfer; design changes; and design history file
28
What is risk management for medical devices?
A systematic process to identify evaluate control and monitor risks associated with medical devices throughout their lifecycle
29
What is ISO 14971?
The international standard that specifies the process for manufacturers to identify estimate evaluate control and monitor risks associated with medical devices
30
What is a risk management file?
Documentation containing records and other documents produced by risk management activities demonstrating compliance with the requirements of ISO 14971
31
What is a CAPA system?
Corrective and Preventive Action system - a set of procedures required by regulatory bodies to collect/analyze information identify/investigate quality problems and take appropriate corrective/preventive actions
32
What is post-market surveillance (PMS)?
The active collection and evaluation of experience gained from devices that have been placed on the market to identify any need to immediately apply necessary corrective or preventive actions
33
What is a Post-Market Clinical Follow-up (PMCF) study?
A continuous process that updates the clinical evaluation of a device by collecting and evaluating clinical data after the device has received regulatory approval and been placed on the market
34
What is the difference between a correction and a corrective action?
A correction is an action to eliminate a detected nonconformity while a corrective action is taken to eliminate the cause of a detected nonconformity to prevent recurrence
35
What is a medical device recall?
A firm's removal or correction of a marketed product that violates FDA regulations and against which FDA would initiate legal action
36
What are the three classes of recalls for medical devices?
Class I (reasonable probability of serious adverse health consequences or death); Class II (temporary health consequences); and Class III (not likely to cause adverse health consequences)
37
What is UDI (Unique Device Identification)?
A system to mark and identify medical devices within the healthcare supply chain consisting of a device identifier (DI) and a production identifier (PI)
38
What is EUDAMED?
The European database for medical devices; a secure web-based portal for information exchange between national competent authorities and the European Commission
39
What is a Qualified Person for Regulatory Compliance (QPRC) or Person Responsible for Regulatory Compliance (PRRC)?
A designated individual within a manufacturer's organization who ensures compliance with regulatory requirements for medical devices as required by the EU MDR
40
What are the differences in medical device classification between major global markets?
US: Classes I II III based on risk - EU: Classes I IIa IIb III with special cases - Japan: Classes I II III IV - Canada: Classes I II III IV - Brazil: Classes I II III IV
41
What is the International Medical Device Regulators Forum (IMDRF)?
A voluntary group of medical device regulators working to harmonize medical device regulation across different regions and jurisdictions
42
What is a Software as a Medical Device (SaMD)?
Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device
43
What are the basic requirements for medical device labeling?
Requirements include device identification; intended use; warnings/precautions; storage/handling information; manufacturer contact details; and region-specific requirements like symbols UDI and CE marking in EU
44
What is a companion diagnostic?
An in vitro diagnostic device that provides information essential for the safe and effective use of a corresponding therapeutic product
45
What is a clinical evaluation for medical devices?
A systematic and planned process to continuously generate collect analyze and assess clinical data pertaining to a medical device to verify safety performance and clinical benefits
46
What is the difference between verification and validation for medical devices?
Verification confirms that specified requirements have been fulfilled (did we build the device right) - Validation confirms that the user needs and intended uses can be fulfilled (did we build the right device)
47
What is a Form 483?
A form issued by FDA to firm management at the conclusion of an inspection when investigators have observed conditions that may constitute violations of the Food Drug and Cosmetic Act
48
What is a Warning Letter?
A correspondence from FDA to a manufacturer notifying them of significant violations of FDA regulations that require prompt correction
49
What is a Consent Decree?
A legal agreement between FDA and a manufacturer that has repeatedly violated cGMP requirements forcing specific changes to be made under court enforcement
50
What are the four elements of proof that FDA must document for enforcement action?
Jurisdiction; Interstate; Violation; and Responsibility
51
What is the difference between adulteration and misbranding for medical devices?
Adulteration relates to product safety composition and manufacturing compliance while misbranding relates to product labeling packaging and promotion
52
What are the requirements for importing medical devices into the US?
Imported products must meet same standards as domestic goods; be declared to Customs and Border Protection; be referred to FDA; and undergo the FDA admissibility process
53
What is an Import Alert?
A notification informing FDA field staff that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation
54
What are the requirements for exporting medical devices from the US?
Requirements depend on whether the device is FDA-approved - Unapproved devices may be exported under conditions if they meet importing country's requirements; labeled for export only; and not sold domestically
55
What is an Institutional Review Board (IRB)?
A committee that reviews and monitors biomedical research involving human subjects with the authority to approve require modifications or disapprove research to protect subjects' rights and welfare
56
What are Good Clinical Practices (GCPs)?
International ethical and scientific quality standards for designing conducting recording and reporting trials that involve human subjects
57
What is the Belmont Report and how does it relate to medical device clinical trials?
The Belmont Report (1979) outlines basic ethical principles for research involving human subjects including respect for persons beneficence and justice forming the foundation for human subject protection regulations
58
How does the FDA classify combination products?
Combination products combine aspects of drugs devices and/or biological products - Classification is based on the primary mode of action (PMOA) which determines which FDA center has primary jurisdiction
59
What is a Human Factors Validation Study?
A study that evaluates whether the intended users of a device can use the product to perform the intended uses in the intended use environment without serious use errors or problems
60
What is a predicate device in the context of a 510(k) submission?
A legally marketed device to which a new device claims substantial equivalence serving as a comparison basis for determining whether the new device can be cleared via the 510(k) pathway
61
What is the role of the FDA's Center for Devices and Radiological Health (CDRH)?
CDRH is responsible for the premarket approval of medical devices as well as overseeing the manufacturing performance and safety of these devices through the total product lifecycle
62
What are the Medical Device User Fee Amendments (MDUFA)?
Legislation that authorizes FDA to collect fees from medical device companies for certain premarket submissions which helps fund and expedite the review process
63
What is the Quality System Inspection Technique (QSIT)?
FDA's approach to inspecting medical device manufacturers' quality systems focusing on four major subsystems: Management Controls; Design Controls; CAPA; and Production and Process Controls
64
What distinguishes devices eligible for De Novo classification?
Novel devices without a predicate that would automatically be classified as Class III but may be eligible for Down-Classification to Class I or II with appropriate benefit-risk profile
65
What are the key requirements for a Quality Management System under ISO 13485:2016?
Requirements include management responsibility; resource management; product realization (including design and development); and measurement analysis and improvement processes
66
What is a Premarket Approval (PMA) supplement?
A submission to FDA requesting approval for changes affecting the safety or effectiveness of a PMA-approved device with various types based on the significance of the change
67
What is the Clinical Evaluation Process under EU MDR?
A systematic and planned process to continuously collect appraise and analyze clinical data pertaining to a device to verify safety performance and clinical benefits when used as intended
68
What are the key differences in advertising and promotion regulations between drugs and medical devices?
Device advertising lacks the detailed regulations that drugs have - FDA has no explicit drug-like regulations for devices but applies similar restrictions - FDA cannot require preapproval under First Amendment
69
What are the Common Specifications (CS) under EU MDR?
Technical specifications adopted by the European Commission that provide a means to comply with the legal requirements for a device when harmonized standards are insufficient
70
What is Post-Market Performance Follow-up (PMPF)?
The continuous process of updating the performance evaluation of an IVD by collecting and evaluating performance data from device use in the actual market
71
What are the key considerations for international registration of medical devices?
Considerations include understanding different classification systems; conformity assessment procedures; labeling requirements; clinical evidence expectations; quality system requirements; and local representation needs
72
What is a Critical to Quality (CTQ) characteristic for medical devices?
A product characteristic that must be controlled within specified limits to ensure product quality and safety identified through risk assessment and design processes
73
What is Process Validation for medical devices?
Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications under actual operating conditions
74
What are the components of a medical device regulatory strategy?
Components include determination of markets/regional requirements; device classification; regulatory pathways; clinical evidence needs; submission timelines; post-market requirements; and contingency planning
75
What is a Health Hazard Evaluation (HHE) in medical device recall situations?
A scientific evaluation of the health hazard posed by a device considering factors like occurrence of adverse events; severity of harm; vulnerability of users; and risk to different populations
76
What is the EU Medical Device Coordination Group (MDCG)?
A group of representatives from all EU member states that provides advice to the European Commission on the implementation of medical device regulations and helps ensure harmonized implementation
77
What are the key differences in clinical evaluation requirements between the US and EU?
The EU requires a comprehensive Clinical Evaluation Report (CER) for all devices while the US clinical requirements vary by regulatory pathway with trials typically required for high-risk devices
78
What is the Medical Device Single Audit Program (MDSAP)?
A program that allows a single regulatory audit of a medical device manufacturer to satisfy the requirements of multiple regulatory jurisdictions including Australia Brazil Canada Japan and the US
79
What are the requirements for software validation in medical devices?
Requirements include documented software development life cycle processes; verification and validation testing; risk management; configuration management; and issue tracking according to IEC 62304
80
What are the considerations for global supply chain management of medical devices?
Considerations include supplier qualification; agreements on quality requirements; change control procedures; nonconformance management; and ensuring compliance with regional regulatory requirements
81
What is market surveillance for medical devices?
The monitoring of products after they have been placed on the market to ensure they continue to meet requirements and do not pose health or safety risks
82
What is a Technical Documentation Assessment under EU MDR?
The evaluation of technical documentation by a Notified Body to assess compliance with the General Safety and Performance Requirements and other applicable requirements of the MDR
83
What is the difference between active and passive post-market surveillance?
Active surveillance involves proactively collecting data through planned activities like post-market clinical studies while passive surveillance involves responding to spontaneous reports of problems or adverse events
84
What is the role of real-world evidence in medical device regulation?
Real-world evidence provides insights on device performance in actual clinical practice supporting regulatory decisions for new indications label expansions and post-market surveillance
85
What is the difference between a significant risk and a non-significant risk device study?
A significant risk study involves a device with potential for serious risk and requires both IRB approval and FDA-approved IDE - A non-significant risk study requires only IRB approval
86
What are the regulatory considerations for combination products?
Considerations include determining primary mode of action; identifying lead regulatory center; addressing device and drug/biologic requirements; developing testing strategies; and navigating complex submission processes
87
What are the regulatory implications of artificial intelligence and machine learning in medical devices?
Implications include addressing continuous learning algorithms; demonstrating performance across diverse populations; managing software changes; ensuring transparency of algorithms; and establishing validation methods
88
What are User Needs Design Inputs and Design Outputs in the design control process?
User Needs are original requirements from user perspective - Design Inputs translate these into technical requirements - Design Outputs are results of design effort that become the basis for the device
89
What is a Design Review in the design control process?
A documented comprehensive systematic examination of a design to evaluate its adequacy to meet requirements identify problems and propose solutions
90
What is a regulatory gap analysis?
A systematic comparison of a product or process against applicable regulatory requirements to identify areas of non-compliance or insufficient documentation requiring remediation
91
What is the difference between verification validation and qualification in medical device development?
Verification ensures design output meets input requirements - Validation ensures device meets user needs - Qualification confirms systems or processes consistently produce expected results
92
What is the role of usability engineering in medical device development?
Usability engineering ensures devices can be safely and effectively used by intended users by applying knowledge about human behavior abilities limitations and characteristics to device design
93
What are the key elements of a Design Control Plan?
Elements include design and development planning; responsibilities; interfaces; design phases; design reviews; verification and validation activities; design transfer; and risk management integration
94
What is the regulatory impact of making changes to a marketed medical device?
Changes may require new submissions depending on safety/effectiveness impact ranging from documentation updates to new 510(k) submissions PMA supplements or significant change notifications
95
What are the key challenges in global medical device harmonization?
Challenges include differing classification systems; clinical evidence requirements; quality system expectations; post-market requirements; and the need to adapt to region-specific regulatory processes
96
What is a medical device Economic Operator under EU MDR?
Economic operators include manufacturers authorized representatives importers and distributors each with specific regulatory responsibilities in the supply chain
97
What is the difference between a medical device incident and a near incident?
A medical device incident is an event that has led to death serious injury or adverse outcome while a near incident is an event that could have led to harm but did not
98
What are the key elements of traceability in medical device manufacturing?
Elements include unique device identification; component traceability; process parameter documentation; test result documentation; and linkage between device history records and distributed devices
99
What is the regulatory framework for Software as a Medical Device (SaMD) in different jurisdictions?
The framework includes classification based on risk and intended use; software development life cycle requirements; verification and validation processes; cybersecurity; and update management strategies
100
What is a medical device Product Specification File?
A compilation of documents containing all the specifications and procedures required to manufacture a medical device similar to a Device Master Record in FDA terminology
101
What are the key considerations for medical device labeling in global markets?
Considerations include language requirements; symbols usage; unique device identification; warnings and precautions; instructions for use format; electronic labeling allowances; and region-specific requirements
102
What is the difference between a medical device complaint and an adverse event?
A complaint alleges deficiencies related to identity quality durability reliability safety effectiveness or performance while an adverse event is an incident that has led to death or serious health deterioration
103
What are the main components of a Design History File (DHF)?
Components include design and development plan; design inputs; design outputs; design verification; design validation; design reviews; design transfer; design changes; and risk management documentation
104
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action?
CDRH
105
A company wants to modify its legally marketed device with a modification that does not affect the intended use or alter the fundamental scientific technology of the device and design outputs meet design input requirements; this change would best be filed as what?
Special 510(k)
106
Under statutory violations; failure to meet 510(k) requirements for a device that is required to have a 510(k) and is in commercial distribution is considered to be what?
Misbranded
107
If a company's competitor is marketing a Class II suture that dissolves and you develop a change in weaving configuration giving your product the same dissolving time; when can your new suture be marketed?
This requires a new 510(k) since significant change in product instructions might affect efficacy
108
Which of the following is exempt from GMP/QSR regulations?
Component manufacturers
109
When a physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device and this side effect is not in the package insert; this event must be reported to FDA no later than?
30 calendar days
110
If a device failure is occurring with greater than expected frequency and investigation implicates improper use by the end user; which typically occurs?
The labeling is revised
111
A handling and storage system for medical devices must always include?
Procedures for receipt and transfer of product
112
When you have modified your 510(k) cleared device with a special 510(k); in which case would you need to create a new listing for the device?
None of the above
113
According to the QSR; when investigating a complaint what is NOT required for inclusion in the record?
Changes in procedures correcting quality problems
114
The QSR calls for manufacturers of finished devices to carry out all of the following EXCEPT?
Audit operations annually
115
Which subsystem is NOT required by FDA to implement and maintain a Quality System?
Test and control article characterization
116
According to Quality System Regulations; re-testing and re-evaluation of nonconforming devices after rework activities must be documented in what?
Device history record
117
Which manufacturers must register their manufacturing facility with FDA?
Foreign manufacturers shipping devices into the US for sale in the US
118
Under 21 CFR 812; the IDE regulation; which statement is FALSE?
The investigator shall report device use without obtaining informed consent to the sponsor and the reviewing IRB within 10 working days after the use occurs
119
When design validation activities are being performed; which element is NOT included as a requirement under device design validation section of QSR?
Translation of device design into production specifications
120
Which type of device must file an IDE before conducting a human clinical study?
A custom device being studied for safety and effectiveness in support of commercial marketing
121
Which statement is NOT true with respect to both INDs and IDEs for significant-risk products?
The investigational product must be manufactured in full compliance with cGMP
122
What MUST an initial importer of a medical device do?
Report incidents in which a device may have caused or contributed to a death or serious injury
123
During a monitoring visit; the sponsor discovers an investigator used a device without obtaining informed consent; what should the regulatory affairs professional do?
Ensure that the study director for the sponsor discusses the issue with the investigator
124
What should the regulatory affairs professional NOT perform prior to submitting a PMA to FDA?
Prepare criteria for the MDR report
125
All Class I medical devices are subject to the following requirements EXCEPT?
Design History File (DHF)
126
MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of what?
Class II and III device
127
For 3rd party establishment inspections; which statement about prescribed conditions is FALSE?
Manufactures of class III devices are not eligible for 3rd party inspections
128
When FDA sends a warning letter citing mislabeling of an artificial knee device; the regulatory affairs professional should first contact?
Compliance Branch in their district
129
To avoid quality deficiencies with device components received from a supplier; what should the supplier first have?
Clear and precise specifications from the manufacturer
130
A legally marketed device to which equivalence is drawn in a premarketing submission is known as what?
Predicate device
131
How does a humanitarian device exemption differ from a traditional PMA?
Effectiveness data are not required
132
Removal of a distributed product for a reason NOT subject to legal action by FDA is known as?
Market withdrawal
133
When modifying a device with a major change to fundamental scientific technology and FDA has published guidance and established special controls; this change would be best filed as what?
Abbreviated 510(k)
134
Under the Medical Device QSR; device design requirements MUST meet the needs of?
Patient and user
135
Under the IDE regulation; which must NOT be reported to the sponsor within five working days?
An unanticipated adverse device effect
136
Which section is required in a PMA?
A discussion of benefit and risk considerations
137
Which of these is NOT a possible reason for refusing entry of a medical device to the US?
Establishment registration by the foreign manufacturer
138
Premarket Notification is required of manufacturers when introducing what?
New Class II devices
139
All of the following are considered General Controls under the FD&C Act EXCEPT?
Premarket approval application
140
According to the QSR; which requirement for equipment maintenance is NOT included?
Maintenance must be performed at least annually
141
Which device would be regulated by CBER?
HIV diagnostic test kit
142
What is NOT a responsibility of the US Agent for a Foreign Establishment?
Report adverse events under the Medical Device Reporting regulation
143
Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?
Medical Device Amendments of 1976
144
Which is NOT a key Medical Device submission leading directly to marketing permission from FDA?
IDE (Investigational Device Exemptions; Part 812)
145
At completion of review of a 510(k); FDA may take the following actions except?
Approve the device for market
146
Which activities constitute pre-clinical activities in medical device development?
All of the above (animal testing; bench testing; biocompatibility testing; functional/safety/performance testing)
147
For a Non-Significant Risk device clinical trial; which is NOT required before starting the trial?
Submission of the trial protocol to FDA for approval
148
The establishment; performance and auditing of a human-use clinical device trial requires conformance with all regulations EXCEPT?
21 CFR 807 Establishment Registration
149
How can a component manufacturer make critical proprietary information available to FDA for a PMA without revealing it to the finished product manufacturer?
Submit a Device Master File (MAF)
150
Under the official definition of a "device"; what is NOT considered a device?
Sterilizers used for device manufacturing
151
Which device's 510(k) Premarket Notification would NOT be reviewed by CDRH's Office of Device Evaluation?
Blood specimen collection device
152
The Quality System Regulation (QSR) pertains to the manufacturing of what type of products?
Finished devices and accessories to finished devices
153
The QSR for Class III devices applies to the following EXCEPT?
Critical component manufacturers
154
The QSR for medical devices requires all of the following EXCEPT?
Management must review the Quality System at least quarterly
155
The QSR for medical devices regarding Design Controls requires what?
Design and development plans address how design inputs and requirements are managed
156
Design Control "verification" requires what?
The product design meets specified requirements
157
According to the QSR; Design Inputs are best described as?
The performance requirements that the product must meet
158
According to the QSR; Design Outputs contain what?
A and D above (The Device Master Record (DMR) and All of the packaging and labeling associated with the finished device)
159
According to the QSR; Quality Audits must accomplish what?
B and C above (Evaluate if the Quality System is in compliance with the QSR and Determine the effectiveness of the Quality System)
160
According to the QSR; personnel involved in design; manufacture; distribution; servicing; and reporting must?
Be made aware of defects which may occur if they do not perform their job correctly
161
According to the QSR; Document Controls apply to?
All of the above (DHF; DMR; DHR)
162
If your firm commercially distributes a Class III device subject to PMA requirements without an approved PMA; what is the statutory violation?
Adulteration
163
Pre-market Notification Requirements would apply to a device that is?
Substantially equivalent to a pre-amendment device
164
As Director of Regulatory Affairs at a contract sterilizer; if you haven't found device listing forms for devices your firm sterilizes; what is the correct response?
Find something else to worry about; contract sterilizers are not required to submit Device Listing forms for the devices they manufacture
165
The MDR regulations do not require which group to notify FDA of reportable information?
Distributors
166
Which condition may lead to a field recall action?
Physical removal of device from point of use to other location for repair; modification; adjustment; relabeling; destruction; or inspection
167
When FDA declares a device from a 510(k) application to be Not Substantially Equivalent (NSE) and requires a PMA; what is the most practicable first option?
Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate
168
The Medical Device User Fee and Modernization Act of 2002 enacted all the following except?
Prescription Drug User Fee Act (PDUFA) renewal for five additional years
169
What is a major difference between an HDE and a PMA application?
Effectiveness requirements
170
What kind of PMA supplement is required when a PSA test manufacturer develops a new automated analyzer with no change to indications or technology; requiring only analytical testing?
180-Day Supplement
171
What is the key difference between EU MDR and FDA 510(k) regarding clinical evidence requirements?
EU MDR requires clinical evidence for almost all devices according to risk class while FDA 510(k) may accept bench testing without clinical data for many devices
172
What is PMCF under EU MDR?
Post-Market Clinical Follow-up is the proactive collection of clinical data about device safety and performance during real-world use after market approval
173
What documentation is required for a Post-Market Surveillance Plan under EU MDR?
It must include PMCF activities/data collection methods/timeline/acceptance criteria/methodology for evaluating data and implementing necessary actions
174
How often must a Class IIb device manufacturer submit a PSUR to the Notified Body under EU MDR?
At least annually
175
What is a Summary of Safety and Clinical Performance (SSCP) and which devices require it?
A publicly available document summarizing safety and clinical data required for Class III and implantable devices under EU MDR
176
What are the four device classifications under EU IVDR?
Class A (lowest risk) through Class D (highest risk) based on intended use and risk factors
177
What is the classification of a companion diagnostic under EU IVDR?
Class C
178
What is a Special 510(k) submission appropriate for?
Minor design modifications with no impact on safety or effectiveness made by the original manufacturer
179
What type of PMA supplement is required when adding a new indication supported by clinical data?
Panel-Track Supplement
180
What is the primary purpose of the Design History File (DHF)?
To document that the device was developed in accordance with design controls per 21 CFR 820.30
181
What must design validation confirm under 21 CFR 820.30?
That the device meets user needs and intended uses under actual or simulated use conditions
182
What distinguishes a Significant Risk (SR) study from a Non-Significant Risk (NSR) study for IDE requirements?
SR studies require both FDA and IRB approval while NSR studies require only IRB approval
183
What is the purpose of a Request for Designation (RFD)?
To determine whether a product is regulated as a drug/device/biologic/combination product and which FDA center has primary jurisdiction
184
What determines the lead FDA center for a combination product review?
The primary mode of action (PMOA) of the product
185
What are the three FDA recall classifications?
Class I (reasonable probability of serious health consequences or death); Class II (temporary/reversible health consequences); Class III (not likely to cause adverse health consequences)
186
What information must be included in the UDI-DI portion of a UDI?
UDI-DI is the static identifier portion that identifies the specific device model/version but not production details
187
What differentiates the Device Master Record (DMR) from the Design History File (DHF)?
DMR contains final device specifications and manufacturing instructions while DHF documents design development history
188
What is required for EU MDR GSPR compliance for software?
Software lifecycle processes including verification/validation/risk management/IT security/interoperability requirements
189
What are the primary requirements for a Post-Market Surveillance system under EU MDR?
Trending/analysis of complaints/adverse events/CAPA implementation/periodic safety reports/trend reporting
190
How does ISO 13485:2016 differ from ISO 9001 regarding continuous improvement?
ISO 13485 requires maintaining effectiveness of the QMS rather than continually improving it as in ISO 9001
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What are the key UDI requirements for reusable surgical instruments under FDA regulations?
Direct marking on the device itself with a UDI that can withstand reprocessing
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What is the primary responsibility of a Person Responsible for Regulatory Compliance (PRRC) under EU MDR?
Ensuring compliance with regulatory requirements throughout product lifecycle including technical documentation and post-market vigilance
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What is the purpose of the Medical Device Single Audit Program (MDSAP)?
A harmonized approach to QMS auditing recognized by multiple regulatory authorities (US/Canada/Brazil/Australia/Japan)
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What are the key elements of a Clinical Evaluation Plan under EU MDR?
Definition of scope/methods/acceptance criteria/schedule for clinical evaluation throughout product lifecycle
195
What is required for establishing equivalence to another device under EU MDR?
Technical/biological/clinical equivalence with access to full technical documentation of the equivalent device
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What are the EU MDR requirements for Class III device labels?
CE mark/UDI/manufacturer information/authorized representative if applicable/warnings/precautions/sterilization information/manufacturing date/expiration date if applicable
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What information must be included in a 510(k) summary?
Intended use/device description/technological characteristics/performance data and substantial equivalence comparison to predicate device
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What factors determine FDA's 522 Postmarket Surveillance Order requirements?
Class II or III devices where failure could lead to serious adverse events or to assess safety issues identified post-market
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What documentation is needed to demonstrate substantial equivalence in a 510(k)?
Comparison of intended use/technological characteristics/performance data showing new device is as safe and effective as predicate
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What is the definition of a significant change requiring a new submission under EU MDR?
A change affecting safety/performance/intended use/risk profile/compliance with applicable requirements
201
What is the purpose of FDA Form 3500A?
The mandatory form used by manufacturers/importers/user facilities to report adverse events to FDA under MDR regulations
202
What must be documented in a CAPA record per 21 CFR 820.100?
Investigation results/actions taken/verification of effectiveness/implementation information
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How does Class D IVD certification differ from Class C under IVDR?
Class D requires Notified Body review plus EU Reference Laboratory (EURL) testing of samples in addition to requirements for Class C
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What information must be included in a clinical investigation plan for a medical device according to ISO 14155?
Rationale/objectives/design/endpoints/population/procedures/risk analysis/data collection/statistical considerations/ethical requirements
205
What distinguishes a market withdrawal from a recall?
Market withdrawal is removal for non-safety reasons (quality/marketing) while recall addresses safety or compliance issues
206
What are the primary documents required in EU MDR technical documentation?
Design documentation/risk management file/clinical evaluation report/performance data/labeling/PMS plan/declaration of conformity
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What is the difference between a Panel-Track PMA Supplement and a 180-Day PMA Supplement?
Panel-Track is for significant changes like new indications requiring clinical data while 180-Day is for significant manufacturing changes or design modifications without new indications
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What is the difference between verification and validation in design controls?
Verification confirms device meets design inputs/specifications while validation confirms device meets user needs under actual or simulated use conditions
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What is a Special PMA Supplement - Changes Being Effected?
A supplement that allows implementation of changes enhancing safety before FDA approval
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What are the key components of a Quality Management System under ISO 13485:2016?
Document control/management responsibility/resource management/product realization/measurement/analysis/improvement processes
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What's the difference between a Traditional and Abbreviated 510(k)?
Traditional provides complete test data while Abbreviated references guidance documents or recognized standards to streamline submission
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How does FDA define adulteration for medical devices?
Devices are adulterated if they fail to meet quality requirements/performance standards/contain filthy substances/were manufactured under unsanitary conditions/fail to comply with GMP requirements
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What determines primary mode of action (PMOA) for a combination product?
The single mode of action expected to make the greatest contribution to the overall intended therapeutic effects
214
How are software as a medical device (SaMD) products classified under the FDA?
Based on the health condition being managed and the significance of information provided for healthcare decisions
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What documentation must be maintained for a supplier evaluation program under 21 CFR 820.50?
Supplier evaluation criteria/methods/results/approved supplier list/ongoing monitoring data
216
What information is required in an MDR report to FDA?
Device information/patient information/event description/date of event/outcome/manufacturer assessment
217
What is the difference between a correction and a removal in FDA recall terminology?
Correction addresses a problem at the usage location while removal physically removes the product from the market
218
What are the requirements for in-house devices (LDTs) under EU IVDR?
Must meet applicable GSPR/have justified manufacturing process/have documented QMS/post-market surveillance system/report serious incidents
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What is the submission timeline requirement for reporting deaths to FDA under MDR regulations?
Within 10 working days of becoming aware of information suggesting device contributed to death
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How does the FDA define a medical device recall?
Removal or correction of a marketed device that violates laws enforced by FDA or that poses a health risk
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What documentation must be included in a 510(k) submission for software?
Software description/architecture/design specifications/hazard analysis/verification and validation documentation/cybersecurity information
222
What are the categories of special controls that FDA can impose on Class II devices?
Performance standards/postmarket surveillance/patient registries/special labeling requirements/guidelines
223
What distinguishes a Humanitarian Use Device (HUD) from other devices?
Treats or diagnoses diseases affecting fewer than 8000 individuals annually in the US
224
What is 21 CFR Part 11 compliance required for?
Electronic records and electronic signatures to ensure they are trustworthy/reliable/equivalent to paper records
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What are the three primary mechanisms of FDA enforcement actions?
Administrative actions (Warning Letters/Form 483); judicial actions (seizures/injunctions); criminal prosecution
226
What are the primary differences between FDA's Quality System Regulation and ISO 13485:2016?
QSR has more emphasis on corrective actions/design controls/management responsibility/production controls while ISO 13485 has more specific requirements for risk management/sterile devices
227
What information must be included in the Device History Record (DHR)?
Manufacturing dates/quantities/acceptance records/primary identification label/device identification/traceability information
228
What documentation is required when using ISO 14971 for risk management?
Risk management plan/risk analysis/risk evaluation/risk control/evaluation of residual risk/risk management report
229
What are the differences between the notified body's roles under MDD versus MDR?
Under MDR notified bodies have expanded oversight including unannounced audits/scrutiny of clinical evidence/more technical documentation review/stricter requirements for product sampling
230
What is the purpose of a Pre-Submission (Q-Sub) meeting with FDA?
To obtain FDA feedback on specific questions regarding testing protocols/data requirements/submission pathway before formal submission
231
When is an IDE supplement required for an ongoing clinical investigation?
For new sites/investigators/protocol changes/informed consent changes/new manufacturing process for investigational device
232
How does Health Canada's medical device classification system compare to FDA's?
Both have four risk-based classes but Health Canada's Class I-IV system aligns more closely with EU classification than FDA's Class I-III system
233
What is the difference between a serious adverse event and an adverse event in clinical investigations?
Serious adverse events result in death/life-threatening condition/hospitalization/disability while adverse events are any unfavorable occurrences in subjects
234
What are the key differences between a traditional 510(k) and a De Novo submission?
510(k) requires a predicate device for substantial equivalence while De Novo creates a new classification for novel devices with moderate risk
235
What are the minimum requirements for UDI labeling on a reusable surgical instrument?
Direct part marking with UDI-DI that withstands repeated reprocessing procedures
236
What criteria determine if a clinical investigation is exempt from IDE requirements?
Non-significant risk determination by IRB/investigations of consumer preference/investigations using approved devices without changing intended use
237
What information must be submitted to FDA in a 30-Day Notice for manufacturing changes?
Description of change/verification and validation methods/results/declaration of conformity to design controls
238
What is a Device Master Record (DMR) required to contain under 21 CFR 820.181?
Device specifications/production processes/quality assurance procedures/packaging and labeling specifications/installation and servicing procedures
239
What is the difference between a Five-Day Report and a 30-Day Report under MDR regulations?
Five-Day Reports are for events requiring remedial action to prevent unreasonable risk while 30-Day Reports are for deaths/serious injuries/malfunctions
240
What information must be included in an IVDR Performance Evaluation Report?
Scientific validity/analytical performance/clinical performance data/methods/acceptance criteria/conclusions
241
What device modifications require a new 510(k) submission?
Changes in intended use/operating principles/control mechanisms/technological characteristics that could affect safety or effectiveness
242
What differentiates a Companion Diagnostic (CDx) from other IVDs?
CDx provides information essential for safe and effective use of a corresponding therapeutic product
243
What are the reporting timelines for Field Safety Corrective Actions (FSCAs) under EU MDR?
Serious public health threats: 2 days; Death or serious deterioration: 10 days; Other incidents: 15 days
244
What documents are required for an EU MDR Clinical Evaluation Report (CER)?
Literature search protocol/data/evaluation/analysis of relevant clinical data/benefit-risk determination/conclusions/qualification of evaluators
245
What are the general controls that apply to all medical devices under FDA regulations?
Registration and listing/medical device reporting/quality system regulations/labeling requirements/510(k) unless exempt
246
What is a Real-Time PMA Supplement used for?
Minor design or labeling changes that do not affect safety or effectiveness and can be reviewed in 90 days or less
247
What distinguishes an IVDR Class D device from other IVD classes?
Class D devices are highest risk and include tests for life-threatening transmissible agents/blood screening/high-risk diseases
248
What are the differences between a Corrective Action and a Preventive Action in a CAPA system?
Corrective actions address existing nonconformities while preventive actions address potential nonconformities that haven't occurred
249
What are the qualification requirements for a Person Responsible for Regulatory Compliance (PRRC) under EU MDR?
University degree in relevant f
