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U.S. FDA [510(K)] THIRD PARTY REVIEW

 
     
 

The FDAMA (FDA Modernization Act), 1997 base on a pilot program from USFDA had launched The Accredited Persons Program, the purpose of which is to improve the efficiency and timeliness of USFDA’s 510(k) Process, by which most of the Medical Devices receive Marketing Clearance in the US. The USFDA has Accredited Third Parties (Accredited Persons) who re authorized to conduct the primary Review of 510(k)s for eligible devices.

This Pilot program is further expanded to encourage greater us of Accredited Persons for the process, and the Third Parties are now allowed to review many class II devices, which were not eligible previously.

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Address : Samrat Corporate Consultants Pvt. Ltd.
​F/7, SHUKUN Plaza, L. G. Corner,
Maninagar, Ahmedabad - 380 008.
Gujarat, INDIA.
Phone : +91 - 94267 56555, +91 - 96016 01345
E-mail : info@samratassociates.com
Telefax : +91 - 79 - 2546 3355
   
 
     
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