Comment Period Extended: Remanufacturing of Medical Devices Draft Guidance and Cybersecurity Discussion Paper

Provide comment on the draft guidance clarifying activities that are likely remanufacturing and the discussion paper on cybersecurity issues

If your email program has trouble displaying this email, view as a webpage. FDA Extends Comment Periods for Draft Guidance on Remanufacturing of Medical Devices and Discussion Paper on Cybersecurity and Servicing The U.S. Food and Drug Administration has extended the comment periods for Remanufacturing of Medical Devices Draft Guidance and Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities. On June 24, 2021, the FDA issued the draft guidance to clarify the activities that are likely "remanufacturing" of a device. Read the Guidance The FDA also issued a discussion paper outlining cybersecurity issues that are unique to the servicing of medical devices. Read the Paper Submit Comments This draft guidance will be open for public comments for 90 days at https://www.regulations.gov under Docket Number FDA-2018-N-3741. Submit comments by September 22, 2021. The discussion paper will be open for public comments for 94 days at https://www.regulations.gov under Docket Number FDA-2021-N-0561. Submit comments by September 22, 2021. Questions? If you have questions about this draft guidance or discussion paper, contact the Division of Industry and Consumer Education.

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