USA – AdvaMed asks FDA to revise draft guidance on medtech inspections

In two comments submitted to US Food and Drug Administration (FDA) draft guidance on inspections of medical device establishments, AdvaMed recommended several changes.

The draft guidance, issued in March, seeks to make the processes and standards for FDA inspections of device establishments uniform, per the criteria set forth under the FDA Reauthorization Act of 2017 (FDARA). Yet AdvaMed argues the draft guidance fails to deliver.

“The current wording of the draft guidance…provides FDA with so much flexibility to deviate from these processes and standards that they are rendered meaningless,” writes AdvaMed senior executive vice president for technology and regulatory affairs Janet Trunzo. The group seeks revisions that address “this shortcoming” and align with least burdensome principles…