Medical Devices

Washington D.C. Attorneys and Advisors to FDA-Regulated Industries

The development, manufacturing, and marketing of a medical device require an in-depth understanding of the Food and Drug Administration (FDA) regulatory process, as well as the ability to interact effectively with FDA personnel. At OFW Law, our attorneys provide comprehensive counseling and advocacy on FDA medical device matters, ranging from product clearance and approval to postmarket requirements, enforcement and compliance issues, and product promotion and advertising issues.

FDA Regulatory Counsel for the Medical Device Industry

At OFW Law, our attorneys understand the FDA regulatory process. Our medical device attorneys advise clients on a broad range of FDA medical device issues, including:

  • Adversarial matters, such as
    • Civil penalty proceedings
    • Criminal prosecutions
    • Injunctions
    • Product seizures
    • Expert witness assistance
    • Lanham Act issues
  • Development of strategies to bring medical devices to market, pre-submission advocacy with key FDA officials, and preparation of necessary regulatory filings, such as:
    • Investigational Device Exemption (IDE) applications
    • Premarket Approval Applications (PMAs)
    • Premarket Notification Submissions (510(k)s)
    • Humanitarian Device Exemptions (HDEs)
  • Compliance with Medical Device Reporting (MDR) requirements, including employee education and system audits
  • Classification and reclassification of medical devices
  • Compliance with Quality System Regulation (QSR) requirements, including employee education and system audits
  • Pre- and post-distribution issues regarding the labeling, advertising, and promotion of medical devices
  • Highly specialized medical device regulatory matters, such as:
    • Medical software, including mobile medical apps
    • In vitro diagnostics
    • Combination products
    • Custom devices
  • Managing risks associated with and responding to FDA enforcement and advisory actions, including Warning Letters and untitled compliance letters
  • Preparing for and managing FDA inspections, including:
    • Conducting pre-inspection audits
    • Assisting during inspections
    • Drafting responses to Forms FDA 483 (inspectional observations)
  • Conducting product recalls and other field actions
  • Medical device listing and establishment registration requirements
  • Medical device import and export issues, such as:
    • Export of unapproved devices
    • Import detentions
    • Import Alerts (automatic detention)
    • Import for export
    • Re-importation
  • Matters concerning clinical trials, such as:
    • Compliance with clinical trial requirements
    • Investigator disqualifications

Legislative Advocacy for the Medical Device Industry

At OFW Law, our attorneys are experienced participants in the legislative process and have played a key role in the enactment of seminal medical device legislation, including the Safe Medical Devices Act of 1990, the Medical Device User Fee and Modernization Act of 2002, and the Medical Device User Fee Stabilization Act of 2005.

We welcome you to read more about our practice by following the links to our related practice areas and to access our seminars for the medical device industry on FDA compliance. Alternatively contact OFW Law for more information about our medical device services.