Medical Devices and the Regulatory Process

One of the biggest issues you face when bringing a medical device product to market is the complicated and ever-changing maze of regulatory issues. We can help you manage food, beverage, and drug regulations (FDA), Medicare and Medicaid coverage and payment rules, and compliance with health care fraud and abuse laws, such as the anti-kickback statute and Stark.

Specifically, we can assist you by:

  • Advising on device clearance and approval strategies, including 510(k) strategies, product classification, and reclassification
  • Counseling on investigational device exemption (IDE) requirements, clinical trial issues, and humanitarian device requirements
  • Developing regulatory strategies such as fast track, accelerated approval, and treatment IDEs to bring new products to market and to patients as quickly as possible
  • Providing counsel throughout the application process, including leading FDA meetings and appeals
  • Advising and counseling on compliance issues of increasing importance to the medical device industry, such as off-label promotion and marketing activities implicating the federal anti-kickback statute, Stark, and the False Claims Act
  • Drafting and assisting with the implementation of compliance programs based on the AdvaMed Guidelines, the OIG’s Compliance Program Guidance, and “best practices” in general
  • Providing training programs for medical device sales force management and field personnel
  • Advising regarding the various legal issues raised by research and clinical trials, including conflicts of interest, agreements with investigators and institutions, IRB issues, and issues in dealing with consent, HIPAA compliance, compensation, and recruitment