By Julian Pecquet - 10/12/10 09:25 PM EDT
A bipartisan group of 12 Energy and Commerce members wrote Tuesday to Food and Drug Administration Commissioner Margaret Hamburg urging caution as the agency revamps the approval process for medical devices.
The FDA has launched an assessment of its pre-market review process for low- and moderate-risk devices, known as 510(k). Some consumer advocates argue the process is too lax and allows unsafe devices to get to market; the industry says the process has an outstanding safety record, and some of the 60-plus changes being considered could disrupt it.
The lawmakers say at least five proposals "should be considered controversial" and "have the potential to disrupt the device review process." They're asking for the FDA to seek additional input from stakeholders and the panel before pressing forward with them.
"Depending on how FDA implements these recommendations," the lawmakers write, "they could prevent companies from using important evidence in product applications, delay the introduction of innovative new therapies, increase the cost and time associated with new product development, and potentially upset the delicate balance that exists between providing information to the public and protecting intellectual property."
The five proposals involve:
• rescission authority;
• split and multiple predicates;
• clarifying intended use and indications for use;
• mandatory pre-market inspections and mandatory clinical information for a subset of Class II devices; and
• proprietary information.
The lawmakers said they're "not necessarily opposed" to the five recommendations but want "more transparency."
They also request that FDA provide: a more detailed work schedule for implementing the recommendations; a breakdown of how changes to the process would be addressed (through guidance, rulemaking or statutory changes); more details on the proposals; and an analysis of the recommendations' economic impact on the domestic medical device industry.