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Device firms can avoid regulatory violations and move their products into the market sooner by building quality systems (QSs) into their clinical trials, according to an FDA official.
The FDA published draft guidance June 20 to help devicemakers understand the process for the review of clinical and nonclinical information in premarket approval (PMA) applications and related inspections under the bioresearch monitoring (BiMo) program.
The FDA is hosting a public meeting in November to discuss its progress in implementing the various provisions of the Medical Device User Fee and Modernization Act (MDUFMA), including the guidances the agency has issued on the law.