USA – FDA Reveals Vision for the Transition to ISO 13485

An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug Administration (FDA) over its recently proposed overhaul of the quality system regulation.

“I don’t mean to disappoint,” said William Maisel, chief medical officer at FDA’s Center for Devices and Radiological Health (CDRH). The plans to blend together certain provisions of  21 CFR Part 820 with ISO 13485 through new rulemaking have been public for about a year “so it’s not new, but it’s true that we think this is the right direction to go,” though it may seem scary for those that are just now finding out, Maisel added.

With CDRH in the midst of mapping out the differences and similarities between the two approaches to auditing medical device quality management systems, Maisel currently sees the overlap to be at about 95%. This means there is still 5% “on the fringes that we need to identify and make decisions about how we’re attempting to tackle them,” he said.

Concrete examples of what is being hashed out in the “crosswalk” include medical device reports, the Medical Device Single Audit Program (MDSAP) and unique device identification.

FDA plans to leverage MDSAP for its nationwide adoption of the globally agreed upon standard on device oversight as the audits are conducted against 13485 under this program…