Devices Guidances
The FDA updated its Center for Biologics Evaluation and Research (CBER) web resources to provide a consolidated listing of Medical Device Guidance documents.
Companies developing or manufacturing medical devices and combination products regulated by CBER, as well as regulatory affairs and quality assurance departments within these organizations.
The centralization of device-specific guidance within the biologics division suggests an effort to streamline access to relevant regulatory expectations. While the source does not detail specific content changes, this repository serves as the primary reference point for maintaining compliance with CBER-specific device standards, which may differ from CDRH requirements for certain specialized products.
Regulatory affairs teams should audit internal guidance libraries against the updated CBER list to ensure active submission strategies align with current Center expectations. Periodically check this consolidated landing page for newly finalized or drafted guidance documents that may impact device-biologic combination products.