When does your medical device testing need IRB approval?

Medical Device studies need Investigational Device Exemption (IDE) determination from an Institutional Review Board (IRB) when:
• Data is being collected on safety and effectiveness regardless of whether or not the results are intended for FDA submission
• New disease or condition
• New intended use
• New patient population
• Significant design changes
• Significant use changes

HOWever, SOME MEDICAL DEVICE USAGE IS EXEMPT FROM

21 CFR PART 812 (IDE):

Medical Device Sponsors and Clinical Investigators may be exempt from 21 CFR Part 812 regulations regarding Investigational Device Exemption (IDE) requirements (meaning that they need neither FDA nor Institutional Review Board (IRB) approval) if the medical device is:

• used in accordance with its legally marketed labeling,

• testing only consumer preference (i.e., no safety or efficacy tests),

• testing a modification that:

(1) is not for the purpose of determining safety or efficacy and

(2) does not put subjects at risk,

• intended solely for veterinary use, or

• a diagnostic that:

• complies with 809.10(c) labeling requirements and

• the testing

• is noninvasive;

• does not pose a significant risk;

• does not introduce energy into a subject; and is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure