Draft Guidance: Peripheral Vascular Atherectomy Devices
On 10th July 2020, the U.S. Food and Drug Administration (FDA) issued the draft guidance: “Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions”. FDA has developed this draft guidance to propose select updates to the FDA guidance document "Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions".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.
This draft guidance, when finalized, will align with the review practices of similar cardiovascular devices. Proposed changes and updates include:
- Clarification of pyrogenicity language,
- Additions to the simulated-use testing recommendations,
- Addition of a particulate evaluation section.