In a related matter, the FDA has issued draft guidance in an effort to clarify when medical devices that were approved through the 510(k) process, but later changed, updated or otherwise modified, must go through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 so-called 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. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement announcing the draft guidance, had this to say:
We are making the regulatory process for medical devices less challenging by better describing our expectations. 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The draft guidance, which can be found on the FDA’s website, clarifies the kinds of changes that trigger the need for a new submission, such as specific labeling changes, changes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. Hopefully, the abuses of the fast-track system will be a thing of the past, but that will only happen if the FDA does its job. Of course, that will require adequate funding from Congress.
Source: Lawyers USA Online
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