Advised diagnostic clients on various permitted "research only" uses and other device status issues, such as whether the diagnostic product will require a 510(k) or a premarket approval (PMA) or may be a combination product based on intended use and claims made.
Assisted clients on performance testing requirements for various types of 510(k)s and advised clients on human clinical study testing requirements under an IDE for both 510(k)s and PMAs.
Advised clients on approval/clearance strategies for medical device and diagnostic products. Prepared or aided in the preparation of 510(k) and investigational device exemptions (IDE), and reviewed labeling for submissions.
Organized Pre-Submission meetings with CDRH, participated in Pre-Sub meetings and negotiated client’s position on 510(k) filings and IDEs with CDRH.
Counseled clients on compliance/enforcement initiatives by the FDA, including device manufacturing inspections, Form 483 responses, Warning Letter responses, border detentions, and product recalls.
Negotiated the extent and depth of device recalls with FDA.
Met and negotiated with the FDA regarding product clearance, labeling, and enforcement initiatives on behalf of clients.
Advised and represented clients regarding combination products issues involving both device/drug combinations and device/biologic combinations.
Assisted clients with Establishment Registration and Device Listing with FDA.
Advised and assisted clients on Medical Device reporting requirements.
Advised clients on CMS reimbursement issues.
Represented clients on export of unapproved Medical Devices, import detentions, import alerts, and re-importation issues.
Assisted clients with regard to highly specialized Medical Device issues including:
Hyaluronic acid material for knee joint injections and for wrinkle reduction
In vitro diagnostics
Combination device/drug or device/biologic products