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Medical Devices

Medical devices are complex. So is the FDA regulatory framework that governs them. As science and technology in digital health and other medical devices continue to evolve at a rapid pace, FDA’s Center for Devices and Radiological Health works to adapt accordingly. We stay on top of it all, providing timely, practical, and strategic regulatory advice to our clients.

Our Work

We work with our clients at all stages of medical device development, tailoring our scope and approach to each client’s needs and business objectives. From product early development to post-market requirements, we advise on navigating the complex regulatory requirements, strategic and policy considerations, and everything in between.

How We Help

Regulatory Strategy and Policy Advocacy

  • Identify and analyze the potential options for market entry consistent with the product type, its intended use, and claims of interest
  • Serve as a strategic thought partner on the potential regulatory options for obtaining FDA authorization for products to be marketed as devices
  • Assess intellectual property and commercial considerations to help inform regulatory strategy
  • Engage in legislative and regulatory policy advocacy, including participating in notice and comment rulemaking proceedings and the development of FDA guidance documents
  • Identify gaps in the current FDA regulatory framework and participate in public workshops and related policymaking in the rapidly evolving areas of digital therapeutics and other novel technology-based devices
  • Analyze, develop arguments for, and prepare Requests for Designation for device-drug/biologic combination products
  • Prepare agreements with institutions and investigators, and coordinate with Contract Research Organizations, for development of medical device products

Pre-Market Regulatory Counseling

  • Draft and negotiate clinical trial, research collaboration, licensing, and related agreements critical to the seamless development and testing of a medical device
  • Advise on and assist with the legal and regulatory aspects of clinical investigations, including Investigational Device Exemptions, Institutional Review Boards, Informed Consent, and Sponsor and Investigator responsibilities
  • Advise on, prepare for, and participate in FDA pre-submission meetings
  • Advise on and assist with 510(k) submissions for pre-market clearance of a device: Traditional, Special, Abbreviated, and Safety and Performance Pathways
  • Advise on and assist with obtaining de novo classifications, including commercial considerations
  • Advise and assist with Pre-Market Approval Applications (PMAs) for marketing approval of devices
  • Advise on and prepare for Advisory Committee meetings

Post-Market Regulatory Compliance

  • Analyze proposed post-market modifications to a device and advise on optimal regulatory approach for implementation
  • Advise on, prepare for, and participate in FDA inspections
  • Respond to FDA inspectional 483s, Warning Letters, and other threatened government enforcement actions
  • Review and advise on labeling and promotional materials, including company website audits
  • Conduct due diligence and regulatory audits of device companies and facilities in connection with potential corporate transactions
  • Review and develop company standard operating procedures
  • Advise on device manufacturing and Quality System Regulation (QSR) requirements and compliance
  • Respond to FDA import Hold Orders to secure release of product detained at the port of entry
  • Assist with compliance with device registration and listing requirements
  • Analyze proposed post-market modifications to a device and advise on optimal regulatory approach for implementation

Key Contacts