“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices
By EsqSocial Corporation 23/06/21
On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to “servicing,” with this designation carrying significant regulatory impact....
By: Hogan Lovells