The U.S. FDA posted a draft guidance providing select updates atherectomy devices for the peripheral vasculature, with a comment period closing Sept. 11, 2020. The draft proposes to amend several provisions of an existing guidance for submissions for the same device type under the 510(k) program, including provisions for software used in connection with these devices. The agency said that recent advances in software that guide the cutting/lasing functions of these devices raise the level of concern (LOC) sufficiently that sponsors will have to document and justify any determination that the LOC for their device does not exceed a minor or moderate LOC based on software failure. Another proposed modification is for pyrogenicity testing, for which ISO 10993 is available as a standard, while the section of the existing guidance for engineering may be modified for simulated use testing. Among the considerations here is that the sponsor should demonstrate that the device is deliverable at the intended access point (e.g., femoral artery) without vascular damage. Interested parties can comment at regulations.gov under docket number FDA-2018-D-2494.
The U.S. Department of Defense has proposed to extend by three years a program for evaluating lab-developed tests that have not been submitted to the FDA for review. The extension is applied to tests conducted anywhere in the world, and thus non-U.S. labs are included so long as those labs are operating in accordance with that host nation’s credentialing standards. In the case of testing in the U.S., labs must be certified under the Clinical Laboratory Improvement Amendments of 1988.
The U.K. Medicines and Health Care Products Regulatory Agency said the head rings in the USS II polyaxial spinal fixation system by Synthes GmbH of Umkirch, Germany, may crack during or after implant. The issue was identified in a November 2019 field safety notice issued by the company, and while the majority of instances of cracking are said to have occurred intraoperatively, the condition might not be identified until the procedure has been completed. Customers are urged to quarantine any unused devices for return to the manufacturer, and patients whose implants took place two years or less ago should be contacted to discuss whether the patient has experienced symptoms suggestive of cracking. Patients reporting symptoms can be radiologically evaluated, and asymptomatic patients should follow up with their surgeon each year for a minimum of two years after implant, the agency said.
Australia’s Therapeutic Goods Administration (TGA) said it has received a “significant number” of applications for inclusion of thermometers and other temperature-sensing devices for inclusion in the Australian Register of Therapeutic Goods (ARTG), an interest prompted by the COVID-19 pandemic. The agency said the guidance posted in response to that interest provides information on whether the device in question is a regulated device, and recommends that sponsors establish the risk classification for their offering prior to filing a regulatory submission. The agency also provided information for devices exported to Australia.