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FDA Regulatory

EBG Advisors has extraordinary expertise in the medical device, biological and tissue products and combination products industries to help navigate the federal regulatory review and approval processes. Our services include supporting clients through the Food and Drug Administration (FDA) clearance and remediation process, as well as other federal and state agencies. Our clients include many of the largest device manufacturers and pharmaceutical companies in the world, as well as dozens of mid-size and smaller companies.

We can help expedite and guide our clients successfully through the regulatory quagmire. Our experience helps drug and medical device manufacturers bring new products and innovations to market quickly and efficiently.  The process has many other facets, from figuring out the best way to collect the scientific and clinical evidence needed by regulators to building an appropriate health economics case for reimbursement. We cover:

  • Early product development and the investigational phases
  • FDA regulatory clearance and approval
  • Quality system remediation
  • Business planning and reimbursement
  • Post-approval compliance and enforcement
  • Regulatory opportunities and other issues

Representative Experience:

EBG Advisors has represented a wide range of clients that offer the following types of products:

  • In vitro diagnostic products
  • Hospital beds
  • Durable medical equipment
  • Orthopedic implants
  • Cardiovascular products
  • Drug delivery products
  • Other combination products

For more information on EBG Advisors’ consulting services for medical device and FDA clearance, please Contact Us.

EBG Advisors is affiliated with the law firm of Epstein Becker & Green, P.C., which has a health care and life sciences legal practice that is among the nation's largest.

NHA offers a broad range of specialized services for our clients, strategically focused on advocating and implementing public policy solutions for numerous sectors of the health care industry.