Medical Device Reporting

ICR 202303-0910-015

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0437 can be found here:

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
6116	Manufacturer Reporting	Unchanged
259221	Postmarketing Safety Reporting for Combination Products	New
251675	Special Controls complaint logs	Unchanged
231473	Voluntary Malfunction Summary Reporting Program	Unchanged
202637	Importer Reporting, Death and Serious Injury - Third-Party	Unchanged
202636	MDR Files	Unchanged
202635	MDR Procedures	Unchanged
202634	Supplemental Reports	Unchanged
202633	Importer Reporting, Death and Serious Injury - Reporting	Unchanged
202632	User Facility Annual Reporting FDA Form 3419	Unchanged
202631	User Facility Reporting	Unchanged
202630	Exemptions	Unchanged

ICR Details