Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in EBG’s Washington, DC office, was interviewed in the September/October 2007 issue of MX Magazine, on current medical technology regulatory issues.
The article, “Roundtable: Medtech’s Outlook in Regulatory Affairs,” presented a discussion about FDA-related legislation and other areas of concern to medical technology (medtech) manufacturers. Legislation moving through Congress includes reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA II), combination products, international harmonization, genetic testing, third-party inspections, unique device identifiers, and device safety to promotional issues.
Thompson commented that the lack of clear FDA guidance in areas such as device advertising and promotion created a source of frustration for companies in the medtech industry. “Companies don’t know what they are permitted to say about their products. And they don’t know when it’s appropriate to share information and when it’s not ?… .” He noted that the industry needed both substantive direction and “a process that can be used to get input from the agency.”