User-Fee Facts: 10 Key Medtech Details From US FDA Agreements
While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.
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Minding The Middle: FDA Fleshes Out De Novo Regs As The Program Expands
A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.
'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.
Senate Approves FDA User Fee Reauthorization Bill On 94-1 Vote
The Senate Aug. 3 swiftly approved the FDA Reauthorization Act (FDARA) on a 94-1 vote. The president is expected to sign the bill, which previously passed the House and will enact the MDUFA IV user-fee agreement and make reforms tied to device accessory review, device facility inspections, and medical imaging FDA reviews.