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New Path For 510(k)s On US FDA's FY 2018 Guidance-Priority Plan

 
• By Sue Darcey

FDA intends to draft a guidance by March outlining a voluntary, alternative 510(k) pathway for sponsors to demonstrate the substantial equivalence of some products by relying more on objective performance criteria.

File Guidance Meaning Document Organized And Direct

US FDA's device center plans to establish a new, voluntary pathway for medtech sponsors to gain 510(k) clearance for some products that puts more emphasis on performance criteria and less on predicate- device comparisons. The proposed approach will be spelled out in a draft guidance slated for release in the first quarter of 2018, according to agency Commissioner Scott Gottlieb.

"This pathway would be available for pre-specified categories of mature devices – those for which safety and performance criteria that...

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• By Brian Bossetta

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New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

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European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
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As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.