FDA Regulatory for Medical Devices

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Medical device companies seeking regulatory strategies to meet a host of key business needs rely on the FDA experience and broad-based knowledge of Ropes & Gray.

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Overview

FDA regulations affect the most critical aspects of a medical technology company’s business, including research and development, product approval, manufacturing, and marketing. Our FDA regulatory team helps medical technology companies devise optimal regulatory strategies to get their products to market, market them legally and effectively, and ensure ongoing compliance with applicable rules.

With clients ranging from the largest multinational manufacturers to mid-sized companies and start-ups, our attorneys understand the compliance needs to companies at different stages of development, ensuring a careful balancing of compliance requirements with business realities. Our clients rely on our deep FDA experience, combined with our firm’s knowledge in related areas such as device-related transactions, research funding, health care regulation, and current government investigation theories, to offer legal advice informed by unparalleled insight into the legal, regulatory, and business environment in which medical technology companies operate.

We assist medical device clients in all areas of regulation including:

Experience

Examples of our regulatory medical device representations include:

  • Counseled a medical device company on its website content and the regulatory requirements for use of social media in certain product communication activities.
  • Advised a multinational medical device manufacturer on FDA marketing authorization submissions, device safety and labeling issues, and product advertising and promotional strategies.
  • Assisted one of the world’s leading medical technology companies in a multi-faceted project which included conducting a regulatory assessment across various aspects of its business, helping the company draft internal policies and guidance, and working with the company to enhance certain regulatory controls. 
  • Advised medical device manufacturers across a range of product types on Quality System Regulation (QSR) issues, Medical Device Reporting, Correction and Removal Reports, and product recalls. Among other things, we have helped clients develop action plans and prepare written responses to FDA inspectional observations and Warning Letters, negotiate with FDA with regard to remedial actions, and implement and obtain FDA close-out of product recalls.
  • Represented a medical device manufacturer in connection with FDA compounding regulations involving one of its drugs resulting in the FDA issuing a letter in support of the company’s position.  Following the FDA letter, we filed an amicus brief on behalf of the client in a pending lawsuit challenging the FDA’s position.  
  • Advised a medical device manufacturer on import and export issues and evaluating whether FDA premarket review was required for planned changes to certain company products. 
  • Represented a medical device manufacturer in responding to a subpoena from the HHS Office of Inspector General relating to the quality control testing and performance characteristics of certain products. 
  • Counseled a major medical device company’s consumer healthcare business with respect to 510(k) submissions, clinical trials, adverse event reporting, and other medical device regulatory matters following the acquisition of a medical device line of business from a competitor.