Medical Devices Applications and Approvals
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Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes dataset is published as part of a pilot program under the Center for Devices and Radiological Health (CDRH)...
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A 510(k) is required when: - Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments t...
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CDRH’s Post-Approval Studies Program ensures that methodologies are well-designed and conducted effectively, efficiently and in the least burdensome manner. In 2005, the Division...
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Premarket Approval (PMA) is the most stringent type of device marketing application required by Food and Drug Administration (FDA). The applicant must receive FDA approval of its P...
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FDA Recognized Consensus Standards database includes standards recognized by FDA and used to make an appropriate decision regarding the clearance or approval of a submission. Infor...