What procedure does FDA use to review a PMA manufacturing section?
When a fileable PMA arrives at the ODE/DMC, the DMC processes the application as follows: • Logs in and tracks the submission. • Assigns due dates for the CDRH offices based on the date of receipt, e.g., 180 days after receipt. • Alerts the ODE Program Operations Staff (POS) of the incoming PMA. • Sends one complete copy of the PMA to OC Field Operations Branch (OC/FOB) within 7 calendar days of receipt. • Files one copy in the DMC. • Further processes the application administratively, prepares a transmittal coversheet, and forwards the document to the appropriate ODE review division or OIVD. When OC/FOB receives its copy of the PMA, it processes the document as follows: • OC/FOB assigns an internal tracking number for the PMA, establishes a due date (see Table 1) for the OC or OIVD review of the manufacturing information, and generates a transmittal coversheet. • The PMA with its transmittal coversheet are delivered to the appropriate enforcement division in OC, or to OIVD. If clinica
