FDA Policy/General
Two Mintz attorneys say a recent FDA announcement that it has deployed agentic artificial intelligence (AI) raises concerns for regulated industries. Writing in their firm’s online newsletter, Joanne Hawana and Benjamin Zegarelli say agency officials predict that integrating agentic AI into regulatory workflows will lead to greater efficiency and
Devices
FDA has published a guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, clarifying how the agency evaluates real-world data to determine whether they are sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for
Drugs
FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for (1) increasing the enrollment of females in clinical trials and non-interventional studies; (2) analyzing and interpreting sex-specific data; and (3) including sex-specific information in regulatory submissions of
Devices
The Government Accountability Office (GAO) is urging HHS to shore up staffing and reassess legal authorities at FDA after finding significant weaknesses in how the agency oversees medical device recalls, including lengthy delays in formally closing recalls of high-risk products. In a just-released report, GAO found that FDA
Devices
The American College of Cardiology has joined the American Medical Association, the College of Healthcare Information Management Executives, and many other healthcare organizations in opposing a proposed change to U.S. cybersecurity policy. Cardiovascular Business reports the proposal, first developed under the Biden administration, claimed it would “better protect the
Devices
An Eagle Hill Consulting independent assessment of FDA’s Total Product Lifecycle Advisory Program (TAP) pilot found it “demonstrates exceptional performance across all key metrics, indicating strong progress toward achieving its outcomes.” The conclusion is in the 12/2025 Final Assessment Report, based on information from 95 TAP innovators and
Devices
FDA has approved the first at-home, prescription-only brain-stimulation device to treat major depressive disorder. Flow Neuroscience says its FL-100 system, a transcranial direct current stimulation (tDCS) device, is designed for adults with moderate to severe depression. It is intended as a stand-alone intervention or as
Devices
Rep. Jan Schakowsky (D-IL) and Sen. Dick Durbin (D-IL) have reintroduced legislation they say will improve the medical device recall process to protect patients. In a statement, Schakowsky says the Medical Device Recall Improvement Act would: * require FDA to establish an electronic format for medical device recall notifications;
Devices
FDA has cleared a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults (ages 22 to 55) with attention-deficit/hyperactivity disorder. The mobile app adapts 13 cognitive training games into a regulated therapeutic module designed to target cognitive processes tied to attention.
Devices
Former FDAer Daniel McMullen, who most recently was director of the CDRH Office of Neurological and Physical Medicine Devices, the agency unit responsible for the total lifecycle review of medical devices such as Neuralink’s brain implant, has joined Neuralink to lead its medical affairs division. The appointment was reported
Devices
A 6/24-7/2 FDA inspection at Envoy Medical in Saint Paul, MN, found Quality System regulation violations in the firm’s manufacturing of the Esteem II implantable hearing system. A just-released 11/11 Warning Letter says the specific violations were: * failure to adequately establish and maintain procedures
Devices
Draeger has recalled (Class 1) its ErgoStar CM 60 (catheter mount 60), an airway connector/catheter mount, after receiving multiple complaints reporting that cracks were forming in the hose of specific catheter mounts. The device is used in respiratory care to link a patient's breathing tube (e.g.
Devices
An FDA advisory committee has voted unanimously against recommending approval of Johnson & Johnson’s V-Wave heart shunt for patients with advanced heart failure who have not responded to medication, citing insufficient evidence that the implant works. The FDA’s circulatory system devices advisory panel voted 15-0 that
Devices
FDA has published a guidance, eCopy Program for Medical Device Submissions, describing how the agency is implementing the eCopy program under the FDA Reauthorization Act of 2017. The document says the eSTAR program is the current program for submissions solely in electronic format. But until eSTAR is implemented for each
Devices
FDA and the Center for Medicare and Medicaid Services’ Center for Medicare and Medicaid Innovation (CMMI) are launching the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices pilot. An FDA Digital Health Center of Excellence announcement says FDA will work with CMMI’s Advancing Chronic Care with Effective
Drugs
The Sedgwick Recall Index for the third quarter of 2025 shows that while the total 97 drug recalls was the same as in the second quarter, the number of recalled units increased 137% to 44.56 million. The report says the average recall size more than doubled between the second
Devices
FDA has issued a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop, warning that improper use could lead to serious injury or death. The alert directs clinicians to follow newly reinforced instructions and supplemental safety guidance. Olympus notified customers of the
Devices
The American Hospital Association (AHA) says it generally supports artificial intelligence (AI) policy frameworks that balance flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety. The association stated its position in response to an FDA request for comment on the measurement and evaluation of
Devices
Glycar has recalled (Class 1) certain batches of the SJM Pericardial Patch because affected units may fail to meet required tensile-strength specifications, potentially leading to serious injury or death. The recall covers one lot of the cardiovascular surgical patch, used for pericardial closure and for the reconstruction or repair
Devices
Baxter has recalled (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurity vulnerability that could allow unauthorized individuals to alter device settings. According to an FDA notice, internal testing revealed that if someone gains physical access to an unattended Life2000 device, they could potentially change therapy settings
Devices
A Massachusetts federal judge has sentenced three former Magellan Diagnostics executives for concealing a device malfunction that produced inaccurately low lead test results for thousands of children and other patients. A Department of Justice statement says the three pleaded guilty either to felony counts of introducing misbranded medical devices into
FDA Policy/General
FDA has issued a draft guidance, Cross-Center Master Files: Where to Submit, with recommendations for master file holders about to which Center a master file is to be submitted (1) that is referenced in and intended to support more than one regulatory submission for which the lead Center for