marketing & labeling compliance

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:

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    Offensively analyze if there are permitted opportunities to optimize
    the labeling/marketing, and

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    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.

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.

To speak with a regulatory consultant, please call 202.552.5800

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise

GLENN STIEGMAN

Vice President Clinical and Regulatory Affairs

Mr. Stiegman manages and directs the clinical and regulatory affairs departments for MCRA and its clients. Mr. Stiegman is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Mr. Stiegman leads the firm's submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions Read More

PH: 202.552.5803

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