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US Medical Device Regulation 101

September 8, 2021

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IRBs and Researchers: Know Your US Medical Device Documentation

Speed the IRB review process by understanding how medical devices are classified and what the IRB must review to approve device research.

What Is a Medical Device?

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

(21 U.S.C. 321(h)))

Devices in the Marketplace: Characteristics by Class

Class I Class II Class III
Characteristics and Risk Lowest risk, simple in design Moderate risk High risk
Most Likely Regulatory Pathway 501(k) exempt 501(k) clearance PMA approval
Example Prescription sunglasses, elastic bandages, hand splint, pharmacy app
displaying information on drug cost, risks, and potential interactions
Powered/adjustable hospital bed, pulse
oximeter, feeding tube, TENS unit, app
connecting a spirometer to a smartphone
Implants (hip, knee, breast), robotic surgical devices, cardiac pacemaker, software for ophthalmic use, smartphone app controlling an insulin pump
IRB Review Required?
Maybe* Yes Yes

*Some Class I, 510(k) exempt medical devices do not require testing in human subjects/IRB review before the product can be marketed. However, manufacturers making safety or effectiveness claims in device packaging or advertising materials should conduct studies in human subjects with IRB approval to support those marketing claims.

IRB Review of Device Studies

IDE Exempt Investigations: Studies Not Requiring an SR/NSR Determination

Eligible Studies:

Provide to IRB:

Studies of Significant Risk and Nonsignificant Risk Medical Devices

Device Status Significant risk Nonsignificant risk
  • Intended as an implant,
  • Used in supporting or sustaining human life,
  • For a substantial importance in diagnosing, curing, mitigating, or treating disease, OR
  • Presents a potential for serious risk to subject
A device which does not meet the definition of a significant risk device
Before a Study May Begin IDE approval from FDA IRB approval of the study
IRB approval of the study
IRB approval of the study
Example Investigational cardiac valve, investigational assay used to determine eligibility for participation in some clinical trials Investigational wearable biometric monitor and
accompanying mobile app
Provide to the IRB
  • IDE number or FDA IDE letter
  • Protocol and consent form(s)
  • Documentation from FDA if applicable (510(k), PMA, FDA determination of device status)
  • Instructions for use, user manual(s), investigator’s brochure, other official device documentation and/as available or a comprehensive description of the device
  • Sponsor’s/investigator’s rationale in support of an NSR determination
  • Protocol and consent form(s)
  • Documentation from FDA if applicable (510(k), PMA, FDA determination of device status)
  • Instructions for use, user manual(s), investigators brochure, other official device documentation, and/or a comprehensive description of the device


501(k): A premarket submission made to FDA to demonstrate the device to be marketed is as safe and effective (i.e., substantially equivalent) to a legally marketed device that is not subject to premarket approval (PMA) requirements

IDE: Investigational device exemption; FDA authorization allowing a device manufacturer to ship the investigational device for the purposes of clinical research (as regulated in 21 CFR 812)

IDE Exempt: A device study that is exempt from IDE regulations by virtue of the criteria listed in 21 CFR 812.2 (c)

PMA: Premarket approval; the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices

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