Devices
FDA has issued Novocure a Not Approvable Letter for its PMA for Optune Mya for treating adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation. The said the agency determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval, according
Devices
FDA is seeking public input on how to evaluate the benefits and risks of medical robots capable of performing tasks autonomously or being operated remotely, as advances in artificial intelligence and connectivity expand their potential clinical applications. In a just-posted discussion paper, CDRH identifies regulatory questions involving autonomous decision-
Devices
FDA is planning to hold a two-day public workshop 12/2-3 to examine the benefits and risks of robotic medical devices capable of autonomous operation or remote teleoperation, potentially informing future regulatory policy for the emerging technologies. The CDRH hybrid workshop is intended to bring together device manufacturers,
Devices
FDA has issued an Early Alert concerning a potentially high-risk defect in Compact Medical's ButterflyBVM bag-valve-mask resuscitators that could cause inadequate ventilation, hypoxia, serious injury or death. The agency said Compact Medical is removing certain lots of the single-use devices and requiring additional pre-
Devices
Harmed Americans for Reform in Medical Device Safety (HARMS) is asking FDA to confirm that robotic surgical systems are investigational when used in nipple-sparing mastectomies. The advocacy group’s 10/31 petition says clarification is needed because of an apparent inconsistency between the agency’s clearance of the da
Devices
At the 13th Annual Symposium on Pediatric Device Innovation, CDRH associate director for the Total Product Life Cycle Advisory Program (TAP), April Marrone, presented tips on the most effective way to use the TAP accelerator, which has already enrolled about 160 innovative devices. An online Medical Design & Outsourcing post
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FDA has issued a revised a 6/2024 draft guidance outlining the performance characteristics manufacturers should evaluate, validate and control for medical devices used to deliver drugs and biological products, including drug-device combination products. The guidance, Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological
Devices
FDA has issued a Warning Letter to Utah-based Chirp Innovations LLC for promoting its cleared Halo Wireless Muscle Stimulator for menstrual pain without obtaining additional marketing clearance and for widespread deficiencies in its quality system and medical device reporting procedures. The 10/2 Warning Letter followed an 11/2025
Devices
Commenting on an FDA proposal for classification of accessories distinct from other devices, including a proposed list of accessories suitable for Class 1, AdvaMed says that device specificity alone does not establish that general controls are insufficient. “Congress required FDA to classify each accessory based on its own risks, not
Devices
FDA has issued a draft guidance outlining plans to require IDE holders to use standardized electronic submission templates, extending the agency's electronic submission requirements to clinical investigations of medical devices. The guidance, Electronic Submission Template for Investigational Device Exemption (IDE) Applications, applies to IDE submissions reviewed by CDRH
Devices
AdvaMed is asking FDA to build on its existing regulatory framework for generative AI (GenAI)-enabled medical devices instead of creating new frameworks that could hinder innovation. In comments responding to an FDA discussion paper, AdvaMed said utilizing GenAI in medical devices “should not fundamentally alter the core principles that
Devices
Risk-management deficiencies and inadequate corrective action procedures were the most frequently recorded problems in FDA medical device inspections conducted under the agency's new Quality Management System Regulation (QMSR), according to an FDA Webview analysis of 2026 inspection data. FDA cited failures to document risk-management processes associated
Devices
FDA's recent Warning Letter to O.N. Diagnostics raises questions about whether the agency is applying an overly expansive interpretation of when software modifications require a new 510(k), according to a new legal analysis. In a 10/26 FDA Law Blog article, attorney Jennifer Newberger examines the
Devices
FDA is alerting health care providers about an import alert for certain Olympus Medical Systems medical devices manufactured in Japan. “Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the agency says. “Therefore, the FDA
Devices
CDRH is accelerating hiring after losing about 22% of its workforce over the past year and a half, including up to 30% of its clinical reviewers and significant numbers of artificial intelligence and digital health specialists. CDRH drector Michelle Tarver disclosed the staffing losses 10/21 at AdvaMed's
Devices
The Bipartisan Policy Center (BPC) says it supports FDA’s goal of a risk-based, least-burdensome approach that gives patients timely access to safe and effective generative artificial intelligence (AI) device functions. Responding to an FDA discussion paper on the subject, BPC makes these key points: * several approaches in
Devices
Industry executives and FDA officials who participated in a 10/19 panel at The MedTech Conference say initial industry concerns about the new Quality Management System Regulation (QMSR) and its implementation by FDA are easing as companies get more experience with inspections under the new protocol. A Regulatory Affairs Professionals
Devices
FDA has released an Olympus Warning Letter, which the company disclosed last week (see story), citing GMP issues raised during inspections of the firm’s facilities in the U.S., Japan, and Europe conducted in late 2025. According to the letter, FDA inspections at six Olympus Medical Systems manufacturing sites,
Devices
FDA has published two hypothetical examples illustrating how manufacturers of AI-enabled medical devices could modify their products under predetermined change control plans (PCCPs) without submitting a new marketing application for each change. The examples, posted 10/20, describe regulatory approaches for a hospital-specific sepsis alert system and a
Devices
FDA has cited Australian medical device manufacturer Saluda Medical Pty. Ltd. for deficiencies involving cleanroom controls, manufacturing procedures and adverse event reporting, according to a just-posted Form FDA-483 related to a 5/25 inspection of its facility in Macquarie Park, New South Wales. In the three-observation Form
Devices
CDRH has issued an early alert after learning that Edwards Lifesciences notifed customers recommending certain delivery systems used for SAPIEN M3 transcatheter mitral valve replacement be removed from where they are used or sold. Affected devices: * Commander M delivery systems (for SAPIEN M3 Transcatheter Mitral Valve Replacement System); Lots: 67718561,