510(k) Submissions

PDG’s 510(k) compilation consists of a series of steps designed to ensure that CDRH accepts the filing. The first step is to determine (to the extent possible) that the 510(k) is the most appropriate regulatory pathway including whether traditional, special or abbreviated 510(k). This is followed by a data review of the device records, comparing them to FDA regulations and guidances, and production of a gap analysis. The next step is preparation of the submission including such critical elements as a detailed technical comparison to the predicate, summaries of all testing, revised labeling, substantial equivalence documentation, the 510(k) summary and other required 510(k) sections. PDG then performs a review of the final documents using the FDA Refuse to Accept Policy checklist to verify that the submission meets CDRH requirements.

PDG may also recommend pre-sub discussion feedback requests and/or discussions with CDRH preceding submission of the 510(k). Such measures are often critical to adequate preparation of the submission. Upon submission and at all points throughout the process, PDG will be your regulatory voice at FDA, including assistance with responses to any deficiencies. Because the team at FDA includes experienced device professionals with access to former FDA inspectors, we know how to facilitate effective communications with CDRH and review all aspects of the data including that of allied vendors, suppliers and manufacturers.

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