The U.S. Food and Drug Administration has issued updated, finalized guidance on a pilot program that will allow accredited laboratories to carry out premarket testing of medical devices, reports MedTech Dive.
The final guidance documents released Thursday feature substantial changes from the draft FDA released for consultation one year ago, including a major expansion of the section explaining what the pilot means for device manufacturers.
FDA overhauled the guidance after feedback from groups including AdvaMed, which broadly welcomed the pilot but identified the need for additional clarity, details and examples in several parts of the document.The agency is seeking to help build a body of accredited testing laboratories that assess whether devices conform to consensus standards. In doing so, FDA could make conformity testing more consistent and drive international harmonization.
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