FDA Provides Accessories Guidance, But May Be 'Missed' Opportunity
While the US agency's final guidance on medical device accessories provides sponsors assurance the agency could be more lenient in classifying their products, an industry group leader says the guidance left a lot of unanswered questions that will continue to create uncertainty for companies.
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The document explains how to request classifications for new or already approved medical device accessories, independently from their parent devices. It replaces a final guidance from January 2017.
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
A bill introduced in the US that industry stakeholders want to be added to the "must-pass" user-fee reauthorization bill would create a tailored approach to classifying or reclassifying device accessories, following up on change made last year that requires accessories to be classified separately from parent devices. Streamlining accessory oversight has been an industry goal, particularly of health-software makers.