Regulatory Services

Postapproval clinical studies are often required as a condition of approval of a PMA. We have experience designing postapproval studies for devices used across many clinical applications.

Our team can assist with the editorial and technical aspects of writing manuscripts that report the results of clinical or non-clinical studies for peer-reviewed medical journals. We have assisted with over two dozen published articles, including co-authoring articles in such journals as the Journal of Vascular Surgery, the Journal of Urology, Gastrointestinal Endoscopy, and the European Journal of Vascular and Endovascular Surgery.

522 studies are post-market surveillance studies that are sometimes required for certain already-approved devices. The FDA will typically order a 522 study if there are questions of specific concern involving the device.

Our team has designed several 522 studies and has managed correspondence with the FDA throughout the studies.

Any interested party can request that all devices of a given type be reclassified (for example, from Class III to Class II). Such petitions involve summarizing the existing information on the device and demonstrating that the reclassification is warranted.