FDA Reg. for Investigational Devices

Question 1

Humanitarian Device Exemption

Answer 1

manufacturer does not need to provide evidence of efficacy
restrictions on profitability
can only be used in a facility after an IRB has approved their use in that facility, except in certain emergencies

Question 2

Humanitarian Use Device

Answer 2

a device that is intended to benefit subjects in the treatment or diagnosis of a disease or condition affecting fewer than 8,000 individuals in the U.S. per year

Question 3

Investigational Device Exemption

Answer 3

an approved IDE means that the IRB (and FDA for significant risk [SR] devices) has approved the sponsor’s study application as meeting the requirements under 21 CFR 812 (Investigational Device Exemptions 2014).

Question 4

Institutional Review Board

Answer 4

any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.

Question 5

Medical Device

Answer 5

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is:
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans or other animals.
Intended to affect the structure or any function of the body of humans or other animals.
Recognized in the official National Formulary, the United States Pharmacopoeia, or any supplement to them (Federal Food, Drug, and Cosmetic Act 2012).
A medical device does not achieve any of its primary intended purposes through chemical action within or on humans or other animals and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Question 6

Non-Significant Risk

Answer 6

a device that does not pose a significant risk to subjects

Question 7

Significant Risk

Answer 7

sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants

Question 8

Transitional Devices

Answer 8

regulated by FDA as new drugs before 28 May 1976

Question 9

21 CFR 50

Protection of Human Subjects

Answer 9

Provides the requirements and general elements of informed consent.

Question 10

21 CFR 56

Institutional Review Boards

Answer 10

Covers the procedures and responsibilities for IRBs that approve clinical investigational protocols.

Question 11

21 CFR 54

Financial Disclosure by Clinical Investigators

Answer 11

Covers the disclosure of possible financial conflicts of interest by clinical investigators.

Question 12

21 CFR 803

Medical Device Reporting

Answer 12

Covers reporting of adverse events (AEs) for approved products (and HUDs).

Question 13

21 CFR 812

Investigational Device Exemptions [IDE]

Answer 13

Covers the procedures for the conduct of clinical studies with medical devices, including application, responsibilities of sponsors and investigators, labeling, records, and reports.

Question 14

21 CFR 814

Premarket Approval of Devices

Answer 14

Covers the procedure for obtaining approval to market certain devices and HDEs.

Question 15

21 CFR 820, Subpart C

Design Controls of the Quality System Regulation

Answer 15

Details requirements to ensure that specified design requirements are met.

Question 16

Class I

Answer 16

lowest risk devices and are governed by general controls (that is, Establishment Registration, Device Listing, Compliance with Good Manufacturing Practice [GMP] regulation, labeling, and Medical Device Reporting [MDR] of death or serious injuries). Examples of Class I devices are surgical gloves and tongue depressors.

Question 17

Class II

Answer 17

moderate risk devices and are subject to both general controls and special controls such as specific FDA performance standards, post-market surveillance, or special control guidance to ensure their safety and effectiveness. Examples of Class II devices are flexible laryngoscopes and surgical drills.

Question 18

Class III

Answer 18

highest risk devices. General controls and special controls alone are not adequate to ensure their safety and effectiveness. These devices therefore require a stringent premarket approval application to be filed before they can be sold in the U.S. They generally are devices that:

Support or sustain life
Are of substantial importance in preventing impairment of health
Present a potential, unreasonable risk of injury or illness
Examples of Class III devices are artificial organs, replacement heart valves, and pacemakers.

Question 19

Classification process of risk for clinical trials

Answer 19

1. sponsor suggests risk category to IRB
2. IRB agrees or disagrees.
   if disagree
   ->sponsor submits IDE to FDA; FDA must approve before investigation begins