Services We Offer

Medical device regulations require approval or clearance for an intended use before a manufacturer can commercialize. As many companies desire technology or indication differentiation from their competition it is critical to both:

  • Offensively analyze if there are permitted opportunities to optimize the labeling/marketing and
  • Defensively adhere to FDA guidelines

Promoting off-label use, either directly or indirectly, can potentially subject device manufacturers to liability and enforcement actions by various government agencies. Further, many companies continue to struggle with developing internal policies and practices regarding permissible off-label communications. MCRA, with its integrated approach with clinical, regulatory & reimbursement is the premier firm to advise on such issues.

Our Integrated Approach

MCRA's regulatory consulting team advises many medical device companies on the FDA’s labeling, advertising and promotional policies to ensure that all promotional materials and statements meet all FDA and FTC requirements for truthfulness, fair balance and full disclosure. MCRA is not only familiar with regulatory requirements and trade association standards, but also industry best practices relating to the marketing and promotion of medical devices and interactions with health care providers.

 

 

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Glenn Stiegman

Glenn Stiegman

Senior Vice President, Clinical & Regulatory Affairs