The FDA is toughening up its rules for reporting malfunctions of low-risk medical devices.
Food & Drug Administration officials issued an update for reporting requirements of so-called "class I" and certain "class II" devices that are not permanently implantable or life supporting or sustaining.
The FDA is now, “required to publish a notice in the Federal Register or send a letter to the person who is the manufacturer or importer of a class I device or a class II device that is not permanently implantable, life supporting, or life sustaining, if FDA finds that such a device should be subject to part 803 in order to protect the public health (section 519(a)(1)(B)(i)(III) of the FD&C Act),” according to the public notice.
If the devices are not the subject of an FDA notice or letter, the malfunction reports, “are to be submitted in accordance with the criteria established by the Secretary (and, by delegation, FDA), which criteria shall require the reports to be in summary form and made on a quarterly basis (section 519(a)(1)(B)(ii) of the FD&C Act).”
Stewart Eisenhart who covers medical device regulatory affairs for Emergo Group, wrote that the FDA’s clarification means the agency will now require “all devices” to reporting requirements previously targeting higher-risk devices.
“The agency plans to more clearly define which devices fall under the less rigorous quarterly malfunction reporting category. In the meantime, the FDA’s clarification states that the agency will subject all devices to more exacting reporting requirements ‘in order to protect the public health by ensuring that there is no gap in malfunction reporting for any device,'” he wrote.
Anyone interested can submit comments to the FDA electronically at Regulations.gov by May 9, 2011.
This week, the agency also issued new guidance for clinical investigations of medical devices for urinary incontinence treatment.
The new guidance covered the full spectrum of devices from low-risk, class I devices, to surgically implantable, class III, devices required to undergo the agency’s rigorous pre-market approval protocal to reach the market.
The FDA recommended that companies divide studies into two phases: "pilot," or feasibility studies and "pivotal" studies that collect primary data to evidence the device’s safety and effectiveness. The company also issued recommendations on the statistal analysis of study data.