Federal Register Notice: FDA is making available a draft guidance, The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations. This document is intended to assist manufacturers in preparing for FDA's review of their PMA manufacturing section and in coordinating the preapproval inspection of the manufacturing operations described in the PMA or PMA supplement. One of the performance goals associated with the Medical Device User Fee and Modernization Act of 2002 legislation is a commitment to improve FDA's scheduling and timeliness of preapproval inspections. The draft guidance does not address premarket notification (510(k)) submissions because a premarket inspection is not ordinarily conducted for 510(k) submissions. To download the draft gudiance, click here. To view this notice, click here.