AI Medical Device Regulatory Classification Tool

Key Definitions

Medical Device (FDA):

Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect structure or function of the body.

Research (Common Rule):

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)).

Clinical Investigation (FDA):

Any experiment that involves a test article and one or more human subjects, and is subject to requirements for submission to FDA (21 CFR 50.3(c)).

Quality Improvement:

Activities designed to improve local processes and outcomes, not designed to contribute to generalizable knowledge. However, if the activity produces a medical device or will be published/shared, it may require regulatory oversight.

⚠️ Important Caveats

Labeling matters less than function: Calling something QI or operations does not bypass FDA requirements if the tool functions as a medical device.
HIPAA applies broadly: Even if not research, use of PHI may require authorization or fall under specific HIPAA provisions.
Multiple frameworks can apply: FDA + Common Rule dual oversight is common for federally funded device studies.
Commercialization changes classification: Internal QI that becomes a commercial product triggers FDA oversight retroactively.
IRB purview varies: Some IRBs apply Common Rule standards to all research regardless of funding source.

AI Medical Device Regulatory Classification Tool

Decision Tree

Key Definitions

⚠️ Important Caveats