Matters
- Obtained release of detained imported VTM test kits intended for use during the COVID-19 pandemic by persuading FDA that the product was eligible for entry under the agency’s enforcement policy.
- Negotiated a rapid medical device review with the FDA resulting in the clearance of an amendment to a 510(k) and a follow-on Special 510(k) within 80 days of starting the project.
- Advised clients producing Personal Protective Equipment for use during the COVID-19 pandemic on how to obtain an Emergency Use Authorization or comply with FDA enforcement policies.
- Negotiated a 510(k) pathway with the FDA for a first of its kind medical device, avoiding the de novo process, and resulting in a 510(k) clearance.
- Successfully appealed an FDA rejection of a clinical trial design for a PMA supplement to enable the medical device company to embark upon its study, leading the FDA to issue guidance to redefine the proper balance between pre-market and post-market data requirements.
