Mark M. Yacura, Partner

Medical Devices and Diagnostics

  • 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
    • Custom devices