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With the Federal Register (FR) publication unavailable, the FDA has published Safety and Performance-Based Pathway on the Guidance Document webpage. Full details will be available in the Federal Register once that site is again functioning. The existing Docket Number for this document is 

FDA-2018-D-1387. For questions about this document regarding CDRH-regulated devices, contact the 510(k) Staff at 301-796-5640. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.

Guidance Document updates on the FDA website


ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs


Rare Diseases: Common Issues in Drug Development

Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection

REMS Assessment: Planning and Reporting


Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

FDA’s CDRH recently released a Safety and Performance-Based Pathway Guidance Document describing a new abbreviated submission process for 510(k)s which aims to simplify submissions for devices which meet performance standards developed by FDA rather than showing outright equivalence in safety/efficacy to the predicate device. This new pathway has the potential for reducing the administrative burden of building a lengthy clearance dossier as well as be a slightly faster way to gain review and clearance. More information will be forthcoming as FDA issues future guidance on the application of this Safety and Performance-Based Pathway to certain types of devices with corresponding FDA-identified performance criteria. Industry may suggest device types for which FDA should consider identifying performance criteria.

Posted in Drug and Device Corner, Drugs, Medical Devices.