Kleinfeld, Kaplan & Becker advises global, mid-sized, and start-up companies on legal and regulatory issues associated with medical devices, including research and development, FDA submissions and user fee issues, marketing, and life-cycle management. We also support clients in implementing corporate compliance programs to ensure marketing in compliance with law and industry guidelines, including drafting compliance programs and training employees.
Our firm has been actively involved in efforts to streamline regulatory requirements leading to expedited 510(k) and PMA clearance, reclassification, novel approaches to GMP/QSR and pre-approval inspections, and assisting in the development of guidance documents.
Our work in medical devices also extends to:
Regulatory Strategy and Submissions
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
Quality Systems Regulation
Our firm helps clients comply with FDA’s device quality system regulations by interpreting the rules, case law, agency guidance, and industry practice. We assist in responding to FDA inspectional observations, warning letters, and other enforcement actions relating to device quality.
Safety, Recalls and Reporting
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.
Labeling and Advertising
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.
Contracts and Due Diligence
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.