Legal Counsel for Medical Device Companies, Importers and Distributors

FDA regulates medical devices from first sale through recall. Since February 2, 2026, the Quality Management System Regulation has aligned FDA's device quality requirements with ISO 13485, and FDA inspects under a new compliance program. Importers, distributors and relabelers also carry obligations that are easy to miss.

MDRXLaw handles the legal and commercial side of device regulation and coordinates with qualified regulatory and engineering consultants when a premarket submission or technical analysis is needed.

Getting to Market

  • Is it a device? Analysis of intended use, classification, exemptions, and FDA's general wellness and software policies.

  • Establishment registration and device listing for manufacturers, initial importers, relabelers and foreign establishments, including the U.S. agent.

  • Labeling and UDI review before launch, including imported products.

Promotion and Advertising

We review websites, sales materials and social media so claims stay within the device's cleared or approved indications, and we advise on FTC substantiation for consumer devices and on competitor false advertising disputes.

After Launch

  • Complaint handling and medical device reporting (MDR) decisions.

  • Corrections, removals and recalls, including reports to FDA under 21 C.F.R. Part 806.

  • FDA inspections, Form 483s and warning letters (see FDA enforcement defense).

Commercial Agreements and Disputes

We draft and negotiate distribution, private label, supply and quality agreements that allocate regulatory duties, complaint handling and recall costs, and we litigate disputes when those relationships break down. For DME suppliers, we also coordinate FDA issues with Medicare enrollment and accreditation.

Talk to Us

If you make, import or distribute medical devices and have a regulatory, labeling or contract question, contact us for a confidential consultation.