FDA seeks November 9 comments on device-safety and biologic collections
Oct 11, 2026 edition · GC-2026-0313 · Published 2026-10-11 · Version 3 · Proposed
FDA requests November 9 comments on two OMB collection extensions covering MedSun and biologics information. The notices retain voluntary MedSun participation and describe biologics burden corrections as non-substantive, without creating a new enrollment or product-deviation reporting deadline.
What happened
The October 8 MedSun notice requests continued electronic adverse-event collection from a voluntary network of approximately 300 facilities. FDA describes device and tissue-product reports, facility profiles, and follow-up information used to understand reported problems. It retains its burden estimate, including an average half hour per response, while discussing suggestions for better coding, EHR exchange, and more tailored burden estimates as matters for future development. Those suggestions are not newly adopted mandatory reporting instruments in this renewal.
The October 9 biologics notice covers existing licensing-related reporting, recordkeeping, and disclosure requirements and associated forms. Its burden table includes product-deviation reports by licensed manufacturers, unlicensed registered blood establishments, and transfusion services under 21 CFR 606.171. FDA corrects multiplication and rounding errors and attributes its overall burden increase to higher observed report volume, expressly stating that the correction is not a substantive or programmatic change. Both notices invite November 9 OMB comments; that date is not a newly created operational deadline for every safety or deviation report.
Scope and timing
- Authority status
- Proposed
- Applicability
- Potentially applicable
- Audience
- Health systems, Provider networks
- Jurisdiction
- Federal
- Recorded date
- 2026-11-09
- Date type
- comment
Why it matters
Device-safety and blood/transfusion owners may have relevant reporting experience. These PRA extensions do not create a new mandatory MedSun enrollment requirement or a new product-deviation reporting deadline. The biologics notice expressly describes its calculation revision as non-substantive.
Recommended action
Route the appropriate docket to device-safety, transfusion or biologics-manufacturing owners for optional comments. Continue applicable existing reporting requirements; do not substitute voluntary MedSun participation for mandatory device reporting.
Sources
- MedSun information collection extensionOfficial · FDA · 2026-10-08 · Source review 2026-10-11
- Biologics license applications collection extensionOfficial · FDA · 2026-10-09 · Source review 2026-10-11
- FDA MedSun extension, retained official Federal Register retrievalOfficial · FDA · 2026-10-08 · Source review 2026-10-11
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