AdvaMed Pushes 510(k) Guidance Changes

“The current draft guidance document is patently unacceptable,” it says, “and our comments submitted to the public document detail our issues. The draft guidance substantively modifies existing regulations and is inconsistent with other FDA policies.”
AdvaMed also says that the proposed 510(k) Program Guidance could significantly affect the notification process and that many aspects of the draft document introduce new questions and challenges for manufacturers. 

“It needs to address how the agency intends to determine a product’s intended use,” the letter says. “The draft guidance suggests that FDA plans to use information other than the proposed labeling, including ‘agency knowledge’ to determine a product’s intended use — an approach that conflicts with the statute. This issue needs to be addressed as it also further hinders the transparency and predictability of FDA’s decisions.”