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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
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-2021-D-0604
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance provides performance criteria for facet screw systems in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for facet screw systems will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.