Medical Devices

Our firm provides advice on all aspects of medical device research, development, and approval, including:

• Investigational Device Exemptions (IDEs)
• 510(k) Premarket Notifications
• Premarket Approval Applications (PMAs)
• De Novo submissions
• Drug and device combination products
• Compliance with post-approval requirements for changes in products, labeling and manufacturing processes
• Interpretation and application of FDA Quality System requirements
• Establishment registration and product listing
• User fees
• FDA reporting requirements
• HIPAA and Privacy Issues

Our firm helps clients assess the risks posed by safety-related manufacturing deviations and contamination, determine whether a recall is needed, and what the scope of any recall should be. We advise on reporting, recall implementation and effectiveness checks, documentation of corrective and preventive actions, and governmental inspections relating to product deviations and recalls.

Our firm advises on all areas of prescription and OTC device labeling, including wording, formatting, submission and/or approval of labels, labeling (such as detail pieces), advertising and other promotional materials (including social media and web promotion). In addition, our firm advises on the use of educational activities and communications with healthcare professionals, and the preparation of policies governing legal compliance for medical device promotional activities. We also provide guidance on Medicare and Medicaid reimbursement issues.

Our firm represents clients in enforcement actions, including responses to FDA inspectional observations, warning letters, recall requests and import detentions, as well as more significant actions such as seizures, injunctions, investigations and negotiation of consent decrees.

Our firm supports clients in negotiating and drafting regulatory-related agreements such as guarantees, labeling agreements, supply agreements, quality agreements, etc. We also carry out due diligence analyses of medical device companies and products that are being considered for acquisition or investment.