"On first reading, FDA's report includes a number of commendable steps to improve the 510(k) process," said Stephen J. Ubl, president of AdvaMed, an industry lobby, in a statement. Still, he worried some changes could cause a "significant disruption" to the nearly 34-year-old 510 (k) process.

One of the industry's biggest beefs is with the FDA's call to create a publicly searchable database that would include design schematics and what the industry considers sensitive proprietary information about devices that "foreign competitors would have access to," Ubl said.


In another possible added burden on developers, the FDA report also recommends manufacturers include all the background scientific information it can on a product regarding its safety and effectiveness.

Medical Imaging & Technology Alliance (MITA), which represents imaging device manufacturers, is also unsure about the full implications of the new report.

"Further study will be required to fully understand the implications of these recommendations," the group said in a statement e-mailed to DOTmed News.

MITA recognized that a number of the changes have the potential to make the clearance process "more rational and predictable." But the group expressed concern that if these changes are implemented incorrectly, it could impede patient access to new lifesaving technology.

The Institute of Medicine (IOM) is undertaking its own review of the procedure and has hosted several public panels. It's expected to submit its report by March.

"Near-term, we do not anticipate relief from an already prolonged, difficult and increasingly demanding 510(k) process," Leerink analyst Wise wrote. "But longer-term, depending on actual enforcement approaches, clearer rules in theory should make the approval process more manageable and predictable vs. the many current uncertainties. This ultimately would be positive for industry."

Heather Mayer contributed to this report.

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