AAMI Asks FDA to Clarify Standards Expectations

The Association for the Advancement of Medical Instrumentation (AAMI) reports that it has sought clarity on what considerations Food and Drug Administration (FDA) review staff would like the association and similar organizations to take into account during the standards development and revision processes.

The association made the request in written comments to draft guidance the agency issued in May on the appropriate use of voluntary consensus standards in premarket submissions. The draft guidance builds upon a document released in 2007, adding information on how applicants have used standards inappropriately in their premarket submissions.

In its comments, which generally welcomed the FDA’s revision, AAMI said that it would be helpful “to know more about ‘how’ standards are used incorrectly or inappropriately, so that AAMI can produce tools (e.g., checklists or guides) that make it easier for industry to know what they are doing incorrectly.”

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Source: AAMI