Sponsors of Some Devices May Submit 510(k)s to FDA Electronically Under New CDRH Pilot Program

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Sponsors of Some Devices May Submit 510(k)s to FDA Electronically Under New CDRH Pilot Program

Dennis Tosh

September 11, 2018 at 02:20 PM EST

Medical device companies now have the option to submit premarket notifications (510(k)s) for certain moderate-risk products to the FDA electronically. A Center for Devices and Radiological Health (CDRH) pilot program, announced Sept. 6, will help the agency evaluate whether use of the agency’s eSubmitter software for 510(k) submissions will produce “well-organized submissions... Read More

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Sponsors of Some Devices May Submit 510(k)s to FDA Electronically Under New CDRH Pilot Program

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