21 CFR 812

Question 1

What is 21 CFR 812?

Answer 1

INVESTIGATIONAL DEVICE EXEMPTIONS (IDE)

Question 2

What is an IDE

Answer 2

An approved IDE permits a device to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.

Question 3

Implant

Answer 3

a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more

Question 4

Investigational device

Answer 4

a device, including a transitional device, that is the object of an investigation.

Question 5

Monitor

Answer 5

used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a sponsor or a consultant to the sponsor, or an employee of or c

Question 6

Noninvasive

Answer 6

means one that does not by design or intention: (1) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or (2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervix

Question 7

Significant risk device

Answer 7

means an investigational device that:

1. Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
2. Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
3. Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
4. Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Question 8

Termination

Answer 8

a discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion.

Question 9

Transitional device

Answer 9

a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976

Question 10

Unanticipated adverse device effect

Answer 10

means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Question 11

Labeling of investigational devices

Answer 11

1. Contents. An IND or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor, the quantity of contents, if appropriate, and the following statement: “CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.”
2. Prohibitions. The labeling of an IND shall not bear any statement that is false or misleading in any particular and shall not represent that the device is safe or effective for the purposes for which it is being investigated.
3. Animal research. An IND shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION - Device for investigational use in laboratory animals or other tests that do not involve human subjects.”

Question 12

Prohibition of promotion and other practices

Answer 12

A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:

1. Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
2. Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling.
3. Unduly prolong an investigation.
4. Represent that an investigational device is safe or effective for the purposes for which it is being investigated.

Question 13

Waivers

Answer 13

A sponsor may request FDA to waive any requirement of this part. A waiver request, with supporting documentation, may be submitted separately or as part of an application.

• FDA action. FDA may by letter grant a waiver of any requirement that FDA finds is not required by the act and is unnecessary to protect the rights, safety, or welfare of human subjects.
• Effect of request. Any requirement shall continue to apply unless and until FDA waives it.

Question 14

Import requirement

Answer 14

a person who imports or offers for importation an investigational device shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation.

Question 15

export requirements

Answer 15

A person exporting an investigational device shall obtain FDA’s prior approval

Question 16

Address for IDE correspondence

Answer 16

1. For devices regulated by the Center for Devices and Radiological Health, send it to the current address displayed on the website https://www.fda.gov/cdrhsubmissionaddress.
2. For devices regulated by the Center for Biologics Evaluation and Research, send it to the current address displayed on the website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
3. For devices regulated by the Center for Drug Evaluation and Research, send it to Central Document Control Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266.

(b) You must state on the outside wrapper of each submission what the submission is, for example, an “IDE application,” a “supplemental IDE application,” or a “correspondence concerning an IDE (or an IDE application).”

Question 17

Application submission

Answer 17

• A sponsor shall submit an application to FDA if the sponsor intends to use a significant risk device in an investigation, intends to conduct an investigation that involves an exception from informed consent ,or if FDA notifies the sponsor that an application is required for an investigation.
• A sponsor shall not begin an investigation for which FDA’s approval of an application is required until FDA has approved the application.
• A sponsor shall submit a signed “Application for an Investigational Device Exemption” (IDE application), together with accompanying materials in electronic format,
• A sponsor shall submit a separate IDE for any clinical investigation involving an exception from informed consent

Question 18

Application: Contents

12

Answer 18

1. The name and address of the sponsor.
2. complete report of prior investigations of the device
3. A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and, where appropriate, installation of the device,
4. An example of the agreements to be entered into by all investigators to comply with investigator obligations under this part, and a list of the names and addresses of all investigators who have signed the agreement.
5. A certification that all investigators who will participate in the investigation have signed the agreement, that the list of investigators includes all the investigators participating in the investigation, and that no investigators will be added to the investigation until they have signed the agreement.
6. list of the name, address, and chairperson of each IRB that has been or will be asked to review the investigation and a certification of the action concerning the investigation taken by each such IRB.
7. The name and address of any institution at which a part of the investigation may be conducted that has not been identified in accordance with paragraph (b)(6) of this section.
8. If the device is to be sold, the amount to be charged and an explanation of why sale does not constitute commercialization of the device.
9. A claim for categorical exclusion or an environmental assessment .
10. Copies of all labeling for the device.
11. Copies of all forms and informational materials to be provided to subjects to obtain informed consent.
12. Any other relevant information FDA requests for review of the application.

Question 19

Investigational plan

10 parts

Answer 19

The investigational plan shall include, in the following order:

1. Purpose.
2. Protocol.
3. Risk analysis. .
4. Description of device.
5. Monitoring procedures.
6. Labeling..
7. Consent materials.
8. IRB information.
9. Other institutions.
10. Additional records and reports.

Question 20

Report of prior investigations

Answer 20

The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation.

Question 21

FDA action on application

Answer 21

FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve it with modifications, or disapprove it within 30 days

Question 22

Sponsor responsibilities for IDE

10

Answer 22

1. responsible for selecting qualified investigators and obtaining investigator agreements
2. ensuring proper monitoring of the investigation and selecting the appropriate monitors
   3.Securing compliance, handling unanticipated events
3. ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation.
4. Complying with labeling, promotion, and import/export regulations
5. maintaining records
6. granting inspections to FDA
7. preparing and submitting reports
   9/ device effects
8. significant risk device determinations

Question 23

Investigator responsibilities

Answer 23

1. responsible for conducting investigation according to the signed agreement, the investigational plan and applicable FDA regulations,
2. protecting the rights, safety, and welfare of subjects under the investigator’s care,
3. control of devices under investigation.
4. grant inspections to fda
5. prepare and submit reports to fda
6. consent and medical records

Question 24

Device classes

Answer 24

Class 1: little regulation
Class 2: performance standards and special labeling
Class 3: Significant risk devices

Question 25

PMA

Answer 25

pre-market approval

Question 26

510k

Answer 26

claim made by the sponsor to FDA that the device is very similar to a device already on the market

Question 27

significant risk device

Answer 27

implant with serious risk to health

supports or sustains like and can pose serious health risk

Question 28

IDE exemptions

Answer 28

1. the device has a 510K
   2, in-vitro diagnostic device
2. qualifies for abbreviated ide

Question 29

HUD

Answer 29

humanitarian use device