Direct comparison
IND vs. IDE: FDA Pathways Compared
IND (21 CFR 312, drugs/biologics) vs. IDE (21 CFR 812, devices): different FDA centers, review clocks, and risk-tier rules explained.
Side-by-side comparison
| Dimension | IND | IDE |
|---|---|---|
| What it covers | Investigational drugs and biologics | Investigational medical devices |
| Governing regulation | 21 CFR Part 312 | 21 CFR Part 812 |
| Reviewing FDA center | CDER (drugs) or CBER (biologics) | CDRH |
| Default timing model | 30-day default review; sponsor may proceed unless FDA imposes a clinical hold | Significant-risk studies generally need affirmative FDA approval before enrollment; non-significant-risk studies typically proceed on IRB approval alone |
| Risk-tier fork | None — same framework applies regardless of the drug's risk level | Central — significant risk (SR) vs. non-significant risk (NSR) determination drives which procedural track applies |
| Typical downstream marketing pathway | New Drug Application (NDA) or Biologics License Application (BLA) | 510(k), De Novo, or Premarket Approval (PMA) |
Common questions
FAQ
Can a single study need both an IND and an IDE?+
Yes — combination products (e.g., a drug-device combination) can require submissions under both Part 312 and Part 812. FDA assigns a lead center based on the product's primary mode of action.
Is an IDE the same as a 510(k)?+
No. An IDE authorizes investigational use of a device to generate data; a 510(k) is a subsequent marketing submission showing substantial equivalence to an already-legally-marketed device.
Do all device studies require FDA to formally approve an IDE application?+
No. Non-significant risk (NSR) device studies typically proceed on IRB approval alone under abbreviated IDE requirements, without a separate FDA submission. Significant risk (SR) studies generally require both IRB and FDA approval.
