FDA MEDICAL DEVICE REVIEWS

Evaluation is Needed to Assure Requests for Additional Information Follow a Least Burdensome Approach

Business & Finance, Accounting, Governmental
Cover of the book FDA MEDICAL DEVICE REVIEWS by Hugues Dumont, Hugues DUMONT
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Author: Hugues Dumont ISBN: 1230002138121
Publisher: Hugues DUMONT Publication: February 3, 2018
Imprint: Language: English
Author: Hugues Dumont
ISBN: 1230002138121
Publisher: Hugues DUMONT
Publication: February 3, 2018
Imprint:
Language: English

Determining that a new medical device is safe and effective is a substantial investment of time and resources for the sponsor and FDA, the agency that regulates medical devices. FDA relies on the device sponsor to provide supporting data at the time of its original submission, and the agency can request additional information during the review. The Federal Food, Drug, and Cosmetic Act, as amended, requires that when FDA requests additional information from sponsors, the agency consider the least burdensome means of evaluating a medical device...

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Determining that a new medical device is safe and effective is a substantial investment of time and resources for the sponsor and FDA, the agency that regulates medical devices. FDA relies on the device sponsor to provide supporting data at the time of its original submission, and the agency can request additional information during the review. The Federal Food, Drug, and Cosmetic Act, as amended, requires that when FDA requests additional information from sponsors, the agency consider the least burdensome means of evaluating a medical device...

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