Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension of Comment Period

摘要

The Food and Drug Administration (FDA) is extending to March 19, 2010, the comment period for the notice that appeared in the Federal Register of Wednesday, January 27, 2010 (75 FR 4402). In the notice, FDA requested comments on a number of identified challenges associated with the 510(k) process. The agency is taking this action to allow interested persons additional time to submit comments.