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GUIDANCE DOCUMENT

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics Guidance for Industry and Food and Drug Administration Staff September 2018

Final
Docket Number:
FDA-2014-D-0900
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

A submitter of a premarket notification submission (510(k)) must demonstrate to the Food and Drug Administration (FDA) that the “new device” is “substantially equivalent” (SE) to a legally marketed predicate device. This guidance is intended to help 510(k) submitters demonstrate substantial equivalence. This guidance does not add new regulatory requirements for submitters, it does not change the 510(k) premarket review standard nor does it create extra or new burdens on what has traditionally been submitted in 510(k)s. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process. Furthermore, this document is intended to serve as an aid for evaluating the benefit-risk profile of a new device in comparison to the predicate 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-2014-D-0900.