FDA Launches Program for Precertifying Software Companies with Records of Quality Design, Validation

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FDA Launches Program for Precertifying Software Companies with Records of Quality Design, Validation

Firms With ‘Culture of Quality’ May Not Need To Provide Premarket Submissions for Some Products

Dennis Tosh

Guide to Medical Device Regulation

August 1, 2017 at 11:13 AM EST

The FDA’s Center for Devices and Radiological Health (CDRH) will develop a pilot program for precertification of software companies. The precertification could in some cases eliminate the need for premarket submissions to the agency for software products regulated as medical devices, the center said. Through the voluntary pilot precertification program, the FDA and participa... Read More

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FDA Launches Program for Precertifying Software Companies with Records of Quality Design, Validation

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