The Food and Drug Administration (FDA) is extending the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021. The FDA requests that interested parties submit either electronic or written comments on the draft guidance by September 22, 2021, to ensure that it considers your comment on this draft guidance before it begins work on the final version of the guidance. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled “Remanufacturing of Medical Devices.” The FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
FDA is extending the comment period on the notice of availability published June 24, 2021 (86 FR 33305). Submit either electronic or written comments on the draft guidance by September 22, 2021, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
For more information, visit https://www.federalregister.gov/documents/2021/08/05/2021-16695/remanufacturing-of-medical-devices-draft-guidance-for-industry-and-food-and-drug-administration or https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remanufacturing-medical-devices.
