- July 27, 2021
- 1:00 PM - 2:30 PM ET
On Tuesday, July 27 at 1 p.m. ET, the U.S. Food and Drug Administration (FDA), hosted a webinar for stakeholders interested in learning more about the remanufacturing draft guidance and the discussion paper on cybersecurity and servicing of medical devices.
- Helped clarify whether activities performed on devices are likely remanufacturing.
- Was intended to convey the FDA's current thinking on applicable definitions, and clarify, not change, the regulatory requirements applicable to remanufacturers.
- Outlined specific cybersecurity challenges and opportunities associated with medical device servicing.
We encouraged all interested stakeholders to join.
As part of the FDA's ongoing effort to provide consistency and better understanding of applicable statutory and regulatory requirements for medical device remanufacturing and servicing, this webinar was intended to clarify the activities that are likely "remanufacturing" of a device and cybersecurity issues that are unique to the servicing of medical devices.
Printable slides are available at CDRH Learn - Specialty Technical Topics, sub-section “Neurological Devices”