Our Team

We help medical device and in vitro diagnostic manufacturers navigate complex FDA regulatory requirements across the total product lifecycle.

We advise clients on both premarket and post-market matters, including preparing and submitting Emergency Use Authorizations (EUAs), Investigational Device Exemptions (IDEs), 510(k)s, De Novo requests, and Premarket Approval (PMA) applications. We also assist clients with pre-submission strategies and represent them in meetings with FDA. On the post-market side, we counsel clients on complaint handling, Medical Device Reporting (MDR), field actions, and Quality System Regulation (QSR) compliance.

Our regulatory insight also extends to M&A transactions, where we provide FDA-related due diligence and help clients assess potential risks and valuations. We have experience conducting internal investigations and advising on FDA compliance considerations in corporate contexts.

Some of our successes include:

  • Obtaining Emergency Use Authorizations (EUAs) for COVID-19 diagnostic tests and personal protective equipment (PPE)

  • Receiving 510(k) clearances for obstetrical and gynecological therapeutic devices, multi-analyte respiratory virus antigen detection tests

  • Receiving De Novo authorization and subsequent 510(k) clearances for liquid chemical sterilants / high level disinfectants

  • Receiving Breakthrough Designation for software device to aid in the prediction or diagnosis of sepsis

  • Defending against potential warning letter for an in vitro diagnostic company

Our industry experience includes roles at a US founded medical device manufacturer specializing in cardiovascular and neuromodulation devices, an international advisory firm focusing on health industries, a boutique law firm, and at FDA. We have led graduate level coursework in regulatory law for medical devices and presented routinely at the Introduction to Medical Device Law and Regulation Course hosted by Food & Drug Law Institute (FDLI). Our insights have been published by FDLI and have been recognized by FDA, trade press, industry associations, and industry peers.