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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.

US FDA issued final guidance to help sponsors better understand how the agency intends to classify accessories to devices. But one industry group leader says the document fails to provide the clarifications that companies in the software space, at least, were looking for, and doesn't address many accessories already on the market.

The guidance, posted Dec. 29, finalizes a draft versionissued early in 2015. (Also see "mHealth Regs: FDA Drafts Wellness, Accessories Guidance Docs" - Medtech Insight, 16 January,...

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