Will medical devices also have a longer and more focused process from the FDA in the future? This group and the follow up report that the FDA step up some of the process that are involved with approving medical devices, similar to the the same footsteps being taken with new drug approvals.
This is more related to implanted devices, which unlike a pill is more of a guest that comes for dinner, the device is moving in to become part of the family. There could be even more positions for employment open up if it is determined that more field inspections, etc. are needed in the process. BD 
A new report from the Advanced Medical Technology Association, or AdvaMed, aims to stress the safety and efficacy of the current Food and Drug Administration (FDA) process for approving medical devices to counter criticism of the process that could appear in an upcoming Government Accountability Office (GAO) report.
GAO reports released in January and May of this year have been highly critical of the FDA’s medical device approval processes. The reports found that the agency has not met requirements to inspect domestic plants manufacturing medical devices every two years, and that FDA also faces major challenges inspecting foreign establishments. The new GAO report is expected to be released in September.
The approval process — also known as a 510(k) — is used for products that the FDA determines to be a low or moderate risk to consumers and are similar to devices already approved. A 510(k) is significantly faster — usually around 90 days — than the pre-market approval process used for higher risk devices, which can take more than 180 days. Additionally, 510(k) approval is less expensive, as companies are not required to conduct clinical trials on the products.
CQ Politics | Industry Goes on Offense on Medical Device Approvals
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