Our medical device practice assists all actors in the supply chain where it regularly handles issues relating to medical device reporting requirements, regulatory pathway options, market entry, current good manufacturing practices (cGMPs) and quality system regulation (QSR) compliance, and postmarket compliance. Our medical device practice stays up to date on new and emerging issues in the life sciences industries, including those involved with various digital health platforms, such as mobile medical apps, software as medical device (SaMD), telehealth, wearable devices, and other health technologies. During the Coronavirus (COVID-19) pandemic, our medical device practice helped companies navigate FDA’s enforcement policies and helped companies bring products to market through designated pathways as quickly as possible, such as the Emergency Use Authorization (EUA) process.
The depth and breadth of our medical device practice spans a broad range of contexts, including:
- Premarket Compliance – We help small and global companies navigate through FDA’s Center for Devices and Radiological Health (CDRH) ever changing policies. We assist when companies intend to bring new devices to market or reconfigure current devices to determine product classifications. Our team has experience working through informal and formal pathways with FDA in determining device classifications (e.g., 513(g) submissions) and challenging FDA decisions on device classifications.
- Market Entry – We assist with Section 510(k) premarket notifications, de novo classification requests, IDE submissions, and humanitarian device exemption (HDE) submissions. Our medical device team also assists with disputes that may arise with FDA during a premarket submission – working with clients and the agency toward resolution.
- Postmarket Compliance – Postmarket compliance requirements can be extensive, and we assist clients in many areas to minimize FDA exposure and maximize marketing potential, which includes, but is not limited to:
- Establishment Registration, Device Listing, and User Fees;
- Medical Device Reporting (MDRs);
- Corrections, Removals, and Recalls;
- Product Enhancement Reportability;
- Labels, Labeling, Advertising, and Promotion;
- Enforcement provisions, including inspections, warning letters, untitled letters, regulatory meetings, and administrative detentions; and
- Export of Devices.
- Drug Product Development and Approval Strategies
- Due Diligence and Transactional Support
- Enforcement & Recalls
- FDA Regulatory Compliance
- Hatch-Waxman Act Litigation
- Human and Animal Food Ingredient Review and Approval Strategies
- Labeling, Advertising, and Promotion
- Litigation and Administrative Advocacy
- Medical Devices
- White Collar Defense & Government Investigations