New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
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One Year Is Not Enough to Harmonize Quality Systems with ISO 13485
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FDA and Industry Reach Agreement on MDUFA V Medical Device User Fees
For a while, it looked like the FDA and medical tech industry might not cut a deal on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V) before the current agreement expires in September. But last week, the agency...
Harmonizing Device CGMP Requirements with International Standards
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