Devices
A 11/9-12/3/2025 FDA inspection at AseptiKits in North Salt Lake, UT, found that the company manufactures and markets several PALA Your Tears models. A just-released 6/4 Warning Letter says the firm’s PALA Your Tears models are adulterated because the firm does not have
Devices
FDA says that based on its data analyses, it has determined that CCIC Huatongwei International Inspection (Suzhou) Co., Ltd., in Suzhou, Jiangsu Province, China, has, in several instances, copied the results of another study or created falsified or otherwise invalid medical device data that were submitted to the agency. “Until
Devices
Sen. Tom Cotton (R-AR) has introduced legislation that would require FDA to review and potentially recall Chinese-manufactured networked medical devices deemed to pose cybersecurity risks to American patients. The proposed legislation, titled the Countering Chinese Cyberthreats for Patients (Countering CCP) Act, would direct FDA and the Cybersecurity and
Devices
Harmed Americans for Reform in Medical Device Safety, which is led by cardiac surgeon Nooman Noorchashm, known to FDA for his opposition to power morcellation and for raising issues about surgical mesh, is petitioning the agency to require Vena Medical to obtain an IDE for its MicroAngioscope. The 6/22
Devices
FDA has formally closed an enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company's Blood Pressure Insights feature should be regulated as a medical device. In a recently issued closeout letter, FDA informed the wearable technology company that it had
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pump systems manufactured by Abiomed and its manufacturing partner Oscor. According to the agency, certain 14 French and 23 French introducer sheaths may develop unexpected leakage from
Devices
FDA has provided additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate development of medical devices intended to reduce avoidable hospital readmissions by supporting patients in home settings following discharge. The challenge, formally known as READI-Home: Reducing Readmissions through Device Innovation for the
Devices
FDA’s release of information from the first 100 medical device inspections conducted under the new Quality Management System Regulation (QMSR) provides a real service for medical device manufacturers that treat QMSR as the inspection model it actually is. That’s the view of independent expert Marcelo Trevino writing in
Drugs
North Dakota State University economics professor Raymond March says there is a clear reason why FDA struggles to provide effective risk management guidance and seems to flounder when asked to manage risk for others: it can’t. Writing for the Independent Institute in an online post, March argues that “risk
Devices
Draeger has expanded a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations used in operating rooms and other procedural settings. The devices are used to deliver inhaled anesthesia and provide both automatic and manual ventilation for adult, pediatric, and neonatal patients. According
Devices
A 2/27-4/5/2025 FDA inspection at the Zoll Medical facility in Chelmsford, ME, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of an automated external defibrillator, ventilator, and electrodes and sensors. A just-released 4/30 Warning Letter says the specific
Devices
CDRH associate director for compliance and quality Keisha Thomas told the RAPS Quality Conference that medical device companies need to treat risk management as an ever-evolving responsibility. Her presentation covered FDA’s new compliance program under the new Quality Management System Regulation, according to a RAPS online post. “Our
Devices
FDA has issued an early alert regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara System, a positive pressure therapy device used to mobilize lung secretions and deliver aerosolized medications. According to the agency, Baxter has initiated an urgent medical device correction involving
Drugs
Three Akin Gump attorneys say that while a 2026 FDA draft guidance on how drug companies may communicate healthcare economic information with payors, formulary committees, and similar entities doesn’t break significant new ground, there are some differences between it and the 2018 final guidance it will replace when it
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation systems manufactured by GE HealthCare, citing concerns that the devices may deliver incorrect oxygen concentrations to newborn patients. The alert follows a company notice advising users to inspect and, if necessary,
Devices
FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the expedited pathway by medical device developers seeking to bring innovative technologies to patients with serious or life-threatening diseases. According to updated figures released by FDA, the agency had granted
Devices
FDA has issued a guidance document outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification requirements, a move aimed at reducing regulatory burdens on manufacturers while maintaining existing safety and quality controls. Under the guidance, FDA said it does not intend to enforce compliance with
Devices
FDA has issued an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the company’s Impella heart pump system, citing concerns about blood clot formation that could lead to serious vascular complications. The agency said it is aware that Abiomed has advised
Drugs
FDA has published a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities: Questions and Answers, with answers to common questions about firms’ communication of health care economic information (HCEI) about their prescription drugs and medical devices to payors, formulary committees, or other similar entities
Devices
DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the commercial market after being designated for destruction, prompting the company to notify users and coordinate with FDA and law enforcement authorities. The company disclosed that the affected sensors were originally
Devices
FDA has published a final guidance, Content of Human Factors Information in Medical Device Marketing Submissions, to provide a risk-based framework to guide manufacturers on the human factors information that should be included in marketing submissions to CDRH, including 510(k)s, de novo requests, PMAs, and HDEs. The
Devices
FDA this week marked the 50th anniversary of the 1976 Medical Device Amendments by highlighting the law’s lasting role in shaping the modern oversight of medical devices. In a new FDA Voices commentary, CDRH director Michelle Tarver said the amendments created the regulatory framework that continues to govern how