Pre-market Approval (PMA) Submission

FDA requires PMAs for high-risk Class III medical devices and in certain cases, innovative technology where no predicate may be identified. The PMA submission and review process is more complex and takes much longer than a 510(k) submission. As one might imagine, the PMA submission requires considerable preparation and resources, due largely to the requirement for clinical evidence of safety and effectiveness. Early stage activities include filing of an IDE and Institutional Review Board (IRB) approval before clinical trials may be commenced.

PDG medical device consultants conceive development strategies that include integration of clinical development in parallel with strategic regulatory planning. Critical to the success of your PMA program is the involvement of a consultant who regularly meets with FDA at the pre-submission stage and understands the myriad of variables involved with clinical trial design. When PDG writes or edits a protocol, all clinical and regulatory elements that shape the requirements for execution of the trial are addressed. PDG routinely selects, validates, qualifies and provides CRO oversight such that study sites keep progress on time.

Our industry professionals are experienced in every aspect of regulatory submissions and our consultants will support each phase of your PMA project, including pre-submission correspondence and communication with FDA, clinical trial design and oversight, and quality system compliance to include all third party vendors and suppliers.