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The U.S. Food and Drug Administration’s (FDA) is canceling the webinar for Final Guidance: Remanufacturing of Medical Devices on June 27, 2024, and intends to reschedule for a later date.
On May 9, 2024, the FDA issued the final guidance as part of its ongoing efforts to help distinguish between remanufacturing and servicing. This guidance clarifies whether activities performed on devices are likely "remanufacturing," which differs from servicing activities such as maintenance and repair. This clarification is intended to help ensure consistency and a better understanding of the regulatory requirements applicable to remanufacturers.
Questions?
For questions about this final guidance contact the Regulation, Policy, and Guidance Staff at RPG@fda.hhs.gov.
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