The Food and Drug Administration (FDA) is taking a second look at medical devices that are cleared for the market with no premarket safety tests. The FDA clearance process is called 510 (k) and it clears a medical device for marketing if it is substantially similar to a device already on the market. It is one way that defective medical devices have been fast-tracked to the marketplace, sometimes to the detriment to patients. Manufacturers sometimes take the liberty to change or modify the medical device after it has received FDA clearance. This notice issued by the FDA on Tuesday, July 26, states that “When the changes could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510 (k) must be submitted.”
The need for a new submission will be required if there are changes to labeling, to the technology used in the device or in its performance, or in the materials used to manufacture the device.
The problem with the 510 (k) process is that a request for approval by the manufacturer is almost never denied. It is more like a shuffling of paperwork than any safety-oriented approval process. The exchange of paperwork provides a clearance to market a device bypassing the more time-consuming premarket approval and clinical trials that prescription drugs must undergo.
The 510 (k) process is intended to give a fast-track approval to low-risk medical devices, however hip implants and surgical mesh, which have been found to be defective medical devices and recalled, are both implanted in the body permanently and both fall under that classification.
The FDA’s Center for Devices and Radiological Health oversees medical device approval.
Sources: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265458.htm, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265458.htm and http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm
