The U.S. Food and Drug Administration (FDA) has issued a new draft guidance intended to clarify its policy regarding the assessment of medical devices offering multiple functions.
The draft guidance, “Multiple Function Device Products: Policy and Considerations,” attempts to clarify the FDA’s intent to evaluate whether any function in a multiple function device could impact the safety or effectiveness of the device’s overall function during its premarket review. The draft guidance also details the kind of supporting documentation that should be included in a premarket submission of a multiple function product.
Comments on the draft guidance can be submitted through June 26, 2018.
The draft guidance is intended only to provide insight into the agency’s current thinking on the subject and is not a substitute for actual FDA regulations applicable to medical devices. Nonetheless, it can provide valuable information for manufacturers and other interested parties seeking device approval under the agency’s pre-market review process.
Read the complete text of the FDA’s draft guidance on multiple function medical device products.
