FDA has requested comments on the regulation of companies that refurbish, recondition, rebuild, remanufacture, or service medical devices. This includes both third parties and the original device manufacturer.
The notice says that FDA would like to clarify these regulations. In particular, it notes that QSR in 21 CFR Part 820 does not cover refurbishers and servicers. However, QSR does include requirements for installation and servicing by the manufacturer.
The request offers definitions for the terms recondition, service, repair, refurbish, remanufacture, and remanufacture. It asks for comments and clarification of the proposed definitions.
The notice also invites comments on a set of questions.
FDA intends to hold a public meeting in 2016 informed by the comments submitted to the docket.
One may submit comments at www.regulations.gov to Docket number FDA-2016-N-0436.