Experience | Mintz

Worked with several Mintz clients operating in non-FDA regulated industries to determine how to manufacture and distribute face masks and alcohol-based hand sanitizers in compliance with FDA's enforcement discretion policies during the COVID-19 pandemic, including by providing promotion and labeling advice.
Counseled multiple Mintz clients developing in vitro diagnostic tests for SARS-CoV-2 on compliance with FDA’s enforcement discretion and EUA policies during the COVID-19 pandemic, including assistance with promotion and clinical testing activities.
Assisted a pharmacogenetics software company with drafting a pre-submission meeting briefing documents, attended the pre-submission meeting with the client and FDA, and counseled the client on drafting a marketing authorization application that addressed the issues discussed at the pre-submission meeting.
Advised numerous Mintz clients developing SaMD or other digital health technologies on selecting the most appropriate regulatory strategy for their products in light of contemporary FDA policies and guidance and avoiding potential regulatory pitfalls relating to software design, quality controls, and pre-market submissions.
Counseled multiple Mintz clinical laboratory clients on the regulatory framework governing in vitro diagnostic tests and restrictions on the development, distribution, and commercialization of laboratory developed tests (“LDTs”) and home-use specimen collections kits.
Assisted a clinical laboratory with responding to multiple regulatory inquiries from FDA and developing a comprehensive corrective action plan addressing noncompliance allegations relating to home-use specimen collection kits and diagnostic assays.
Participates in the Medical, Legal, and Regulatory (“MLR”) Committees that are engaged in promotional review activities on behalf of multiple clients with recently approved new drugs and biologics.
Provided extensive assistance to a major medical device manufacturer in responding to regulatory observations from multiple FDA inspections and enforcement actions, including a Warning Letter and a regulatory meeting, including development of a corrective action plan, assisting with the implementation and effectiveness evaluation of corrective and preventive actions, and auditing the company’s complaint handling and MDR reporting systems.
Collaborated with ML Strategies to develop a comprehensive strategy to advocate FDA and Congress for development and implementation of regulatory oversight for third-party servicers of medical devices on behalf of a major medical device manufacturer.

FDA Team Helps Novel Therapeutic Developer Obtain Orphan Drug Designation

Mintz advised Glia, LLC on its successful bid to obtain orphan drug status from the FDA for its topical gel to treat ocular Graft-versus-Host Disease. The disease can affect stem cell or bone marrow transplant recipients and cause intense eye pain, ocular degeneration, and blindness.

Mintz Helps Client Navigate Medicare & Medicaid Coverage

Mintz is helping a manufacturer and distributor of device systems used in wound treatment pursue Medicare and Medicaid coverage options throughout the country, including negotiating coding. Mintz attorneys met with the Centers for Medicare & Medicaid Services (CMS) regarding scope of coverage.

Communication Key in Client's Response to FDA

Mintz is helping a client that manufactures medical technologies for facility and home-based care design and implement corrective actions in response to an FDA follow-up inspection. Although the client has two open FDA inspections, Mintz attorneys have helped the company avoid a warning letter.