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AdvaMed asks FDA to limit changes to the 510(k) program

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With the U.S. Food and Drug Administration's 510(k) process for clearing low- and moderate-risk medical devices in the midst of being revamped, Advanced Medical Technology Association has expressed its support of the government agency's efforts to change the program.

However, while the Advanced Medical Technology Association (AdvaMed) wants the FDA to improve the 510(k) process as a strategic priority of its Center for Devices and Radiological Health (CDRH), the association is worried that "the over 60 proposed changes could negatively impact the agency's mission to ensure American patients have timely access to safe and effective medical technologies," according to an AdvaMed statement.

"We urge FDA to move forward with changes to the 510(k) premarket review program in a way that builds on the strengths of the current program," Janet Trunzo, AdvaMed executive vice president for technology and regulatory affairs, said in a press release. "While many of the agency's recommendations have the potential to increase the efficiency and consistency of the review process, others could chill device innovation and the flow of improved products to patients without corresponding public health benefits."

AdvaMed issued the statement after an FDA public meeting to discuss the administration's progress and plans for revamping the 510(k) program.

"Implementing so many changes would likely overwhelm the agency and industry and have the effect of disrupting, rather than improving, an already effective program," Ms. Trunzo said. She also noted that the quality, rather than quantity, of the proposed changes is most critical.

"FDA should focus on changes that are targeted, have a corresponding public health benefit, strengthen the current system and enjoy broad support," Ms. Trunzo said in the release.

Based on AdvaMed's statement, good areas to start focusing on include increased reviewer training, development of key guidance documents and improving the de novo review pathway.

In August, CDRH released two comprehensive evaluations of the 510(k) program compiled by committees formed in September 2009. During the 60-day review period for the documents, which ended Oct. 4, the FDA reached out to stakeholders such as AdvaMed.

“The 510(k) review process is well-designed to assess the safety and effectiveness of low- and moderate-risk medical devices whose risks are well understood from experience with similar devices," AMO Senior Vice President and AdvaMed Chairman Jim Mazzo told Ocular Surgery News. "The basic structure of the 510(k) process is sound, but every process can be improved. AdvaMed has been engaged with FDA and provided extensive comments and recommendations to the agency on ways to improve the clarity and consistency of the 510(k) process and we feel any new regulatory requirements should balance FDA’s dual mission of protecting the public health while facilitating innovations that benefit patients.”