The FDA Issues Draft Guidance on Remanufacturing of Medical Devices and Discussion Paper on Cybersecurity and Servicing Many medical devices are reusable and need maintenance and repair. Servicing of devices is critical to their safe and effective use. The U.S. Food and Drug Administration (FDA) has issued two documents as part of its ongoing efforts to help distinguish between remanufacturing and servicing. To clarify the activities that are likely "remanufacturing" of a device, the FDA issued the draft guidance: Remanufacturing of Medical Devices. Facts about the draft guidance This guidance: - Helps clarify whether activities performed on devices are likely remanufacturing.
- Is intended to describe the FDA's current position on remanufacturing, and to clarify, not change, the regulatory requirements applicable to remanufacturers. It is not intended to adopt significant policy changes.
Discussion paper on cybersecurity and servicing The FDA is also committed to strong cybersecurity practices related to the servicing of medical devices and is releasing a discussion paper, Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities, to outline cybersecurity issues that are unique to the servicing of medical devices. Upcoming webinar on this guidance On July 27, the FDA will host a webinar for stakeholders interested in learning more about the guidance and discussion paper. Submit Comments This draft guidance will be open for public comments for 60 days at https://www.regulations.gov under Docket Number FDA-2018-N-3741. The discussion paper will be open for public comments for 60 days at https://www.regulations.gov under Docket Number FDA-2021-N-0561. Questions? If you have questions about this draft guidance or the discussion paper, contact the Division of Industry and Consumer Education. | 
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