![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA to Consider Mapping of ISO 13485
FDA to Consider Mapping of ISO 13485
March 8, 2018
The FDA is moving closer to a decision on whether to add clauses from ISO 13485:2016 to the regulatory requirements for U.S. medical devices.
“In the spirit of global harmonization of quality management systems, the FDA is considering an evaluation/mapping of the 13485 clauses to the appropriate U.S. regulatory requirements,” an agency official said.
The FDA plans to publish a proposed rule early in 2019 aligning the current Quality System Regulationwith the international standards of ISO 13485:2016.
Upcoming Events
-
21Oct