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GUIDANCE DOCUMENT

Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration September 2019

Final
Docket Number:
FDA-2018-D-1387
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance provides FDA’s current thinking on expanding the concept of the Abbreviated 510(k) Program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the guidance is to describe an optional pathway – the Safety and Performance Based Pathway – for certain, well understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1387.