FDA issues guidance on modified medical devices

By Kimberly Atkins The Daily Record Newswire The Food and Drug Administration has issued draft guidance in an effort to clarify when medical devices that were approved through the 510(k) process but later changed, updated or otherwise modified, must go through the premarket approval process again. The 510(k) process, the approval avenue for lower-risk devices, requires device makers to demonstrate that the new or modified product is substantially equivalent to another legally marketed medical device. But if modifications made to such devices affect the product's safety or effectiveness or change its intended use, another 510(k) must be submitted. "We are making the regulatory process for medical devices less challenging by better describing our expectations" said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in a statement announcing the draft guidance. "In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money." The draft guidance, which can be found on the FDA's website, clarifies the kinds of changes that trigger the need for a new submission, such as specific labeling changes, changes in the technology used, changes in performance specifications, manufacturing changes and changes in materials used to make the device. Published: Mon, Aug 1, 2011