As discussed in more detail below, the PMA regulation (21 CFR 814.42(e)) identifies the criteria that, if not met, may serve as a basis for refusing to file a PMA. This guidance is intended to be used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process.

Focusing the Agency’s review resources on complete applications will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. Moreover, with the enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Amendments of 2007 (MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III), and the Medical Device User Fee Amendments of 20171 FDA agreed to performance goals based on the timeliness of reviews. Acceptance review therefore takes on additional importance in both encouraging quality applications from PMA applicants and allowing the Agency to appropriately concentrate resources on complete applications.

Therefore, we have modified the PMA filing guidance and checklist. We have separated the criteria for PMA filing into 1) acceptance criteria and 2) filing criteria. Acceptance review involves assessment of the completeness of the application, and informing the applicant in a written response within the first 15 calendar days of receipt2 of the application by the document control center (DCC) whether any elements are missing, and if so, identifying the missing element(s). In order to enhance the consistency of our acceptance and filing decisions and to help applicants better understand the types of information FDA needs to conduct a substantive review of a PMA, this guidance and associated checklist clarify the necessary elements and contents of a complete PMA application. The process we outline is applicable to all devices reviewed in a PMA application and has been compiled into a checklist for use by FDA review staff.

FDA staff and industry should note that this guidance is not significantly different from the previous PMA filing checklist and guidance document, as the PMA filing criteria defined in the regulation have not changed. The “preliminary questions” remain the same and the “filing review questions” have been separated into “acceptance decision questions” (i.e., whether the file is administratively complete) and “filing decision questions” (i.e., whether the data are consistent with the protocol, final device design, and proposed indications). In the 2003 PMA Filing Guidance, we stated that delayed submission of the manufacturing section would not preclude filing a PMA, and, if this section was not included in the original PMA application, recommended submitting this section within 90 days. However, delayed submission of the manufacturing section has rarely occurred in recent years, and in many cases this section is submitted prior to other sections of the PMA, as part of a modular PMA submission. Therefore, we are now including the manufacturing section in the checklist for a complete PMA application for an original PMA or a panel-track supplement (with a new manufacturing site or substantially different manufacturing procedures).

FDA encourages all applicants to provide an electronic copy (eCopy) in place of one of the six hard copies of the PMA application. FDA has issued guidance3 to implement Section 745A(b) of the FD&C Act, added by section 1136 of FDASIA, which provides statutory authority to require an eCopy for most submissions, including original PMAs and PMA supplements. With the implementation of this provision, a valid eCopy will be required in order for a PMA or PMA supplement to be processed and for the acceptance review to begin.

Posted on the FDA website on 30 January 2018