pharmdgroup01

This is interested in manufacturers that are submitted two copies of their 513(g) requests to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER). These are associated with fees for reviewing requests. PDG may be recommended pre-sub discussion feedback requests and/or discussions with CDRH preceding submission of the 510(k).

Call : 08133332950
Email : [email protected]
Visit : https://pharmdevgroup.com/complete-guidance-of-513g-exempt-devices/