MDUFA V: FDA Proposes New Program To Engage External Experts Early – But Industry’s Skeptical
The US agency is asking medtech companies to fund a program that would bring together external experts to advise on their products early on, but industry is skeptical about the program’s ability.
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MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds
In newly published meeting minutes, industry and the US FDA continued to clash over a proposal to create a new pre-submission advisory program and what to do with carryover user-fee funds.
The most recent Medical Device User Fee Amendments meeting minutes expose how the US agency and the medtech industry continue to disagree over the agency’s previous user-fee commitments and desire to get more funding.
FDA Blames ‘Super Office’ Reorg For Falling Short On 2019 Review-Time Goals For Recalls, High-Risk Adverse Events
The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.