The regulatory services provided to our clients (sponsors of medical devices) include developing regulatory strategies for successful submissions, preparing plans for FDA interactions and resource planning. We can prepare an entire regulatory submission, individual sections of a submission, or simply review the submission the sponsor has prepared.

Our services include:

• Strategic regulatory consulting and planning, including:
  • Development of preclinical and clinical trial design
  • Medical device classification
  • Submission classification for products with combined regulatory status
  • Interpretation of legislation, regulations, and guidelines, including import and export applications
  • Regulatory review of advertising and promotional material
  • Due diligence and consultation with venture communities and law firms on acquisition and compliance issues
  • Guidance on access to investigational devices during regulatory application preparation and review
• FDA Submission: Complete or partial submission management, preparation and evaluation (e.g., IDEs, 510(k)s, PMAs, HUDs, HDEs, Supplements, Updates, Amendments, Petitions, etc.).
• FDA Representation: Preparation and coordination of strategic and pre-IDE meetings with regulatory authorities including “relationship” guidance and panel meetings.
• Post-market surveillance program evaluation and guidance, including post-approval studies, safety issues and alerts, and labeling review.
• Humanitarian Device Exemption guidance and assistance.