'Quik' Review Program Builds On US FDA eSubmission Efforts

The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.

train fast run on railway track in sunny day

US FDA is unveiling a new pilot program that will encourage companies to submit 510(k)s electronically with the promise of a quicker review time.

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The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.