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Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA has developed this draft guidance to propose select updates to the FDA guidance document "Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions." The existing guidance on peripheral vascular atherectomy devices remains in effect, in its current form, until this draft select update is finalized. FDA intends to incorporate this draft select update guidance with the existing guidance into one final guidance document after obtaining and considering public comment on these select updates. The proposed sections referenced below are intended to replace applicable sections of or add new section(s) to the existing atherectomy guidance after FDA considers public comment on this draft select update. FDA does not intend to substantively change the sections of the existing atherectomy guidance that are not affected by this select update.
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:
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-2494.