Devices Flashcards
(39 cards)
2 step process for HDE
Get a HUD designation from the FDA, submit the HDE to the Office of Device Evaluation
-except in an emergency, can only use after FDA approves HDE, then IRB approval
4 Types of Devices
Significant Risk
Non-Significant Risk
Humanitarian Use Device (HUD)
Exempt
Abbreviated IDE requirements for a NSR device
labeling
monitoring
reporting unanticipated adverse device effects
record keeping
Both ISO & FDA regulations
address overseeing the use of an investigational device
Clinical Device Reports
-financial disclosure to sponsor for 1 year after the study, keep records for 2 years and submit COI to IRB
-to the sponsor, monitor, & reviewing IRB at least anually (progress report)
-protocol deviations-notify sponsor & IRB w/in 5 working days if it is done for emergency use
-UADE to sponsor & IRB ASAP, but no later than 10 working days
-UPs to the IRB if unexpected, serious, and has implications for the ocnduct of a study
-If withdrawal of IRB aprpoval submit to sponsor within 5 working days
-submit the final report ot the sponsor & IRB within 3 months
Device Classifications: Class 1
lowest risk, safety adherence to general standards (ex. tongue depressors)
Device classifications: Class 2
moderate risk, general standards & other standards for this class (ex. surgicall drills)
Device classifications: Class 3
high risk or new to FDA without prior safety info (ex. pacemakers)
Emergency Research IDE
IRB agrees that it is a life-threatening situation, available treatments are unproven/unsatifactory
-collection of valid scientific evidence is ncessary
-for in-vitro diagnostic devices- informed consent is waived for leftover human specimens collected for another purpose as long as not identifiable and the individuals caring for are not part of the research
Exceptions from Informed consent for Devices-FDA
- individual has life-threatening condition & met & document
- investigator and another physcian believe it necessitates the use of the test article
- the subject/LAR is unable to communicate consent
- insufficient time to obtain consent from LAR
- no alternative exists with an equal or better chance of saving life
- IRB is informed within 5 working days
Exempt Devices
Does not include invasive sampling procedure, no more than minimal risk, diagnostic devices
-does not introduce energy into the subject
-not used in a diagnostic procedure without confirmation of diagnosis by another medically established product or procedure
-no IDE application
FDA IDE Investigation begin
After the FDA approves the IDE or 30 days have passed since the FDA received & no notice it can’t begin
FDA IDE Submission requirements for significant risk devices
- Sponsor contact info
- report of prior investigations
- summary of complete investigational plan
- description of methods, facilities, & controls used to manufacture, process, pack, store, & install the device
- sample investigator agreement
- certification that all investigators have signed
- contact info for all IRBs
- certification actions take by each IRB regarding the study
- organization contact info
- if device will be sold, amount charged, & explanation of why it is not commercialization
- categorical exclusion/environmental assessment
- copies of device labeling
- forms, info to subject & ICF
- any other relevant info
FDA Office of Orphan Prodcuts Development (OOPD)
-advance evaluation & development of products (device & drug) that demonstrate promise for the diagnosis & treatment of rare diseases/conditions
-HUD within grants HUD designation
-encourages discovery & use of devices in HUD populations
-Provides manufactures with incentive to develop products for small populations when costs exceed returns
GCP Devices ISO (International Organization for Standardization)
ethical design, conduct, recording, & reporting of clinical investigation to assess safety & performance of medical devices
-origin in DOH & Neuremberg
-Device studies outside the US
HDE (Humanitarian Device Exemption) Holder
-the entity that obtains approval from the FDA, could be an individual, firm, sponsor, or manufacturer
HDE Holder Responsbilities
- ensure appropriate labeling
- ensure HUD in facilities with IRB oversight
- monitor # people that use the device support not more than 8,000
- Ensure not used prior to IRB approval
- provide users HUD patient informational packet
- Maintain IRB correspondence
- Retain distribution & shipping records
- Report clinical experience, safety info, to FDA-annual reports
HDE Withdrawal
if the device affects moer than 8,000 people in the U.S. a year or if a comparable device is approved, or if the device is approved
HUD & HIPAA
21st Century Cures Act
Clinical use-ni HIPAA authorization
Investigational Use-requires authorization
-6/7/2017-expanded HDE criteria to 8,00, removed requirement IRB to be local
HUD & ICF
-ICF is not required for research if clinical use, but IRB may require ICF as condition for approval, not FDA required
-Also for an HUD, you must label it as an HUD, that it is specific for a treatment, there is no effectiveness data, and post signs where it is stored to prevent unathorized use
HUD Clinical Use vs. HUD investigational use
Clinical: use according to approved labeling to treat/diagnose
-Investigational: collection of safety & effectiveness
HUD Patient Information Packet-for Clinical Use
-No ICF, so risks, benefits, warnings, precautions, contraindications, procedures, must be in information packet
-CDRH HDE listing has ones that are already available
-If no packet, the FDA says you have to give the patient, known risks, explanation of HDE labeling, there is no comparable device, ancillary procedures, use of HUD, postulated mechanism of action, effectivenss not demonstrated
-inform patients of financial cost
Humanitarian Use Device (HUD) investigational use
clinical investigation designed to collect safety & effectiveness data
-clinical use of a HUD according to it’s approved labeling & indications
-must have an ICF approved by an IRB
-depends on if you are using an already approved HDE indiciation or testing an indication outside the approved HDE
-If wanting to investigate a new indication outside of teh FDA HDE, must meet IDE requirements
Humanitarian Use Devices (HUDs)
- intended to benefit patients in treatment or diagnosis of a disease or condition affecting fewer than 8,00 individuals in the U.S. per year
- request to FDA office of orphan products development, response within 45 days that it is approved, returned, or disapproved
- if approved, submit an HDE (Humanitarian Device exemption)
- no evidence of efficacy, only safety needed, and probably benefits to health that outweighs the risk of injury/illness
- restrictions are placed on profitability & can only be used after IRB approval
- must demonstrate no comparable devices are available
- approved HDE authroizes HUD marketing
- Lable must state HUD & effectivenss has not been demonstrated
