Devices
FDA has published a guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, to provide a “forward-thinking approach to promote the development of safe and effective artificial intelligence-enabled medical devices.” The document specifically provides recommendations on the information to include
Biologics
The House Select Subcommittee on the Coronavirus Pandemic has issued its final 550-page report that generally praises actions taken under the Trump administration and criticizes actions taken by the Biden administration. A committee statement (including a link to the full document) says “After Action Review of the Covid-19
Devices
Baxter is recalling (Class 1 device correction) its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. Baxter says
Devices
FDA has approved a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for primary and revision reconstruction breast surgery in women. The silicone gel-filled implant line “features an expanded range of base widths, projections, and volumes in an entirely new range of sizes extending from 930 cc to
Devices
FDA commissioner Robert Califf says it would be helpful if Congress gave the agency authority to set standards in the postmarket phase of artificial intelligence (AI) usage. Califf was interviewed on setting guardrails for AI in health care by JAMA+ AI editor-in-chief Roy Perlis in a JAMA article.
Devices
A 5/13-5/16 FDA inspection at Adept Medical Ltd. in Auckland, New Zealand, found Quality System Regulation and other violations in the firm’s manufacturing of NeoZoline ventilation tubes. A just-released 10/11 Warning Letter says specific violations were: * failure to establish and maintain procedures for acceptance
Devices
FDA has approved a Zimmer Biomet PMA supplement for its Oxford Cementless Partial Knee. The company says the device allows partial knee replacement procedures with “improved fixation, better long-term implant survival rate and improved efficiency in the operating room compared to the Oxford Cemented Partial Knee procedure.” Unlike traditional
Devices
ICU Medical has recalled (Class 1) its Plum Infusion Systems after receiving reports of allegedly counterfeit CSB Energy Technology batteries being used with the devices. “While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and
Devices
FDA is publishing two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers. The first guidance, “Orthopedic Non-Spinal Bone Plates, Screws, and Washers — Premarket Notification (510(k)) Submissions,” provides recommendations for submissions involving non-resorbable bone plate, screw, and washer devices.
Devices
FDA has cleared a Royal Philips 510(k) for remote scanning and remote protocol adjustment features on Philips Radiology Operations Command Center. The enhancements mean “expert radiologists can now assist technologists on-the-spot, by remotely controlling scans or adjusting protocols to acquire high-quality images needed for improved diagnostic
Devices
CDRH says a new device recall pilot program will look to improving communication timeliness about corrective actions being taken by companies on high-risk recall issues. “These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety
Drugs
The more than 200 special agents working in the field for the FDA Office of Criminal Investigations (OCI) executed more than 290 arrests and achieved over 300 convictions in FY 2023. Writing in an FDA Voices post, assistant commissioner Justin Green, who heads OCI, says the group’s work “sends
Devices
While an FDA draft guidance on chemical analysis for biocompatibility assessment of medical devices is a “step in the right direction,” additional guidance is needed to address some of its “burdensome” recommendations. That’s the view of Adrienne Lenz, the principal medical device regulation expert at Hyman, Phelps & McNamara,
Devices
Clinicians from several academic medical centers say litigation involving the Cook Celect inferior vena cava filter “demonstrates the need for greater transparency in medical device regulation,” especially involving 510(k) clearances. Writing in the Annals of Internal Medicine, the authors say (subscription or purchase required) regulatory reforms are necessary to
Devices
FDA says the Draeger 10/15 recall (correction) for its Atlan A350 and A350XL anesthesia workstations is Class 1. An agency notice says the company sent customers an urgent medical device correction indicating that a company representative would make contact to arrange for a ventilator motor assembly replacement. The notice
Devices
Smiths Medical is recalling (Class 1) its CADD-Solis Li-ion Rechargeable Battery Packs to update instructions for use due to a potential issue where battery pack damage may lead to an electric short within the battery that melts the pack casing and stops the battery from being able to
Devices
FDA has published a guidance, 510(k) Third-Party Review Program and Third-Party Emergency Use Authorization (EUA) Review, with information on the two programs. The document says the guidance’s objectives are to: * describe and distinguish FDA’s expectations for the 3P510k review program and 3PEUA review; * the factors
Devices
After reiterating that it believes FDA lacks the authority to regulate laboratory-developed testing services, the American Clinical Laboratory Association (ACLA) submits comments on an FDA draft guidance on predetermined change control plans (PCCP) for medical devices “to ensure that PCCPs can be leveraged by laboratories to support continued rapid
Devices
FDA has cleared an Ultromics 510(k) for the EchoGo Amyloidosis, an artificial intelligence-based echocardiography device to assist with early detection of cardiac amyloidosis. The company says this is the first device to reach the market under CDRH’s Total Product Lifecycle Advisory Program. “The device was among 15
Devices
The FDA Digital Health Advisory Committee will consider 11/20-21 FDA questions about the regulation and oversight of generative artificial intelligence (GenAI)-enabled medical devices. A briefing document distributed in advance of the committee meeting says the “novel capabilities of GenAI may offer unique benefits to patients and public
Devices
FDA has cleared a BrightHeart 510(k) for its artificial intelligence (AI) software for reviewing prenatal ultrasound evaluations of the fetal heart. The AI software is designed to “improve the detection of morphological abnormalities suggestive of congenital heart defects (CHDs) in resource-constrained practices,” the company says. “Our AI-powered
Devices
FDA has issued an alert about safety concerns with the use of Getinge/Maquet’s VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices. In September, the company sent customers an Urgent Medical Device Removal notice telling them to not use the devices because there