Policy & Regulation
FDA, CMS and lawmakers: guidance, coverage decisions, recalls and enforcement.
FDA Early Alert Covers All Medline Beds After Two Deaths and Market Exit
Medline reported two deaths and 16 serious injuries tied to fire and entrapment hazards, then revised its removal to allow continued use with new instructions.
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CereVasc Alzheimer's Study Shows How an Investigational Device Exemption Works
Cooper Companies CEO Albert White Steps Down; Rosebrough Named Executive Chair
FDA Expands Instylla's Embrace Hydrogel Embolic Approval to Peripheral Arterial Bleeds
Heat Packs and Heating Pads Make Up 83% of FDA Reports on Physical Therapy Devices
Boston Scientific Cuts 2026 Guidance for a Third Time After Cyberattack
More in Policy & Regulation
FDA Drafts Guidance Requiring eSTAR Template for IDE Applications
Once final, investigational device exemption applications would have to be filed electronically after a transition of at least one year, with no waivers planned.
FDA Finalizes Guidance on Labeling Apps Used With Prescription Drugs
The agency treats app content as drug labeling and says device-connected apps generally belong in prescribing information, while most standalone app content will be treated as promotional.
FDA Names Nova Biomedical StatStrip Hospital Glucose Meter Removal a Class I Recall
Prior scan data can stay on the Gen 2.0 meter's screen and send a glucose result to the wrong patient's record, according to the FDA.
Olympus Receives FDA Warning Letter Covering Six Manufacturing Sites
The letter, dated October 7, follows late-2025 inspections in Japan, Germany and the US and centres on the company's quality management system, Olympus said.
FDA Early Alert Flags Philips Lumify Ultrasound Flaw Linked to Four Deaths
A software issue can block scanning when the app-based ultrasound has no Wi-Fi or cellular signal, with delays in care reported in pre-hospital settings.
AdvaMed Asks CMS to Widen RAPID Medicare Pathway for Breakthrough Devices
The trade group wants broader eligibility, room for diagnostics and firm timelines as comments on the proposed coverage route close October 13.
FDA Updates BD Alaris Infusion Set Class I Recall After BD Revises Performance Data
An updated FDA notice adds products after BD said testing showed some sets perform significantly worse than the company had previously disclosed.
FDA Device Center Puts AI, Change-Control Plans and Surgical Robots Atop FY 2027 Guidance List
CDRH's annual lists name the guidance documents it intends to publish this fiscal year, and comments on the priorities are open until November 30.
FDA Posts Class 2 Recalls of 11 United Imaging CT and PET/CT Scanner Models
A study-splitting software problem can keep patient images from appearing on the scanners' administration screen, which may lead to rescans, the company told the FDA.
FDA Classifies Abiomed's Removal of All Automated Impella Controllers as Class I Recall
Abiomed is replacing purge sensor components in every controller worldwide after reporting 37 serious injuries and three deaths associated with the issue.
FDA Issues Draft Guidance on Premarket Submissions for Surgical Robots
The draft sets out testing, clinical data and labeling recommendations for teleoperated robotic systems and treats their clinical studies as significant risk.
CMS Adds Heart Failure, COPD and Substance Use Tracks to ACCESS Payment Model
The outcome-based Medicare model for technology-supported chronic care will take on the new conditions in spring 2027, two months after its July launch with 160 organizations.
FDA Classifies Medtronic Bravo CF Capsule Delivery Device Removal as Class I Recall
The recall covers 127,416 reflux-testing delivery devices worldwide, and Medtronic has reported 184 serious injuries and no deaths associated with the issue.
CMS Finalizes TAVR Coverage Update, Adding Asymptomatic Aortic Stenosis Under Study Rules
The final national coverage decision drops the evidence-development requirement for symptomatic patients and replaces hospital volume floors with operator thresholds.
FDA Posts BMC Medical's Class I Recall Announcement for Luna G3 APAP Devices
BMC says a firmware update reached most of 20,160 sleep apnea devices in 2024, but up to 196 units may still run the affected version.
FDA Rates GE HealthCare Portrait Monitoring Software Correction a Class II Recall
An update to the August 21 early alert says software updates could drop patients from the Portrait Mobile system and reset alarm settings to factory defaults.
FDA Finalizes 510(k) Guidances for Dental Composite Resins and Curing Lights
The two documents replace guidance from 2005 and 2006 and change how curing light output should be measured.
Medicare Contractors Hear Support for Topical Oxygen Coverage Proposal for Foot Ulcers
Speakers at the DME MACs' open meeting backed covering the therapy for chronic diabetic foot ulcers but asked for looser blood-flow and healing-progress rules.
MolDX Expands Medicare Coverage of NeoGenomics RaDaR ST to Immunotherapy Monitoring
The tumor-informed blood test is now covered for tracking response to checkpoint inhibitors in late-stage solid tumors, its third Medicare indication, the company said.
Boston Scientific ENROUTE Transcarotid System Removal Classified as Class I Recall
The FDA database entries cover more than 164,000 units of the transcarotid neuroprotection systems, recalled over possible arterial sheath tip separation.
FDA Final Order Moves Cancer-Drug ISH Tests to Class II, Ending PMA Requirement
In situ hybridization tests tied to an approved oncology drug can now be cleared through a 510(k) once the order takes effect on September 16.
CMS Puts RAPID Device Coverage Plan Out for Comment, Pausing TCET Intake
The Federal Register notice would put a proposed national coverage decision out the day the FDA authorizes an eligible device, and pauses the TCET pathway for new candidates.
FDA Proposes Moving Digital Breast Tomosynthesis Systems to Class II
The proposed order would let new 3D mammography systems reach the market through 510(k) clearance with special controls, instead of premarket approval.
Medicare Final Rule Ends Breakthrough Device Shortcut to Add-On Payments
Starting with fiscal 2028 applications, FDA-designated breakthrough devices must show substantial clinical improvement to win inpatient add-on or outpatient pass-through payments, with a two-year grandfather period.
FDA Revises Human Factors Guidance to Match 2026 Submission Guidance
The update to the agency's 2016 usability engineering guidance changes its definitions and documentation section to line up with a companion guidance finalized in May.
FDA Drafts Guidance on Pens, Syringes and Other Device Parts for Biosimilars
Sponsors would compare their delivery device's user interface with the reference product's in three structured analyses, with human factors data possible when differences touch critical tasks.
FDA Sets Fiscal 2027 Device User Fees; PMA Fee Rises to $636,732
Fees for the last year of MDUFA V go up about 10% for submissions, while the annual establishment registration fee climbs to $13,785 after a performance adjustment.
FDA Updates 510(k) Guidance for Hemodialysis Blood Tubing Sets
The revised document replaces 2008 guidance, aligning its biocompatibility advice with the agency's ISO 10993-1 guidance and dropping submission-format material now handled by eSTAR.
FDA to Close Manufacturing Readiness Pilot to New Applicants in April 2027
A strategy document fulfilling a PDUFA VII commitment says the pilot for fast-moving drugs and biologics filled 10 of 27 possible slots in its first three years.
CMS Proposes Ending Medicare Payment for Vendor-Run Remote Monitoring
The 2027 physician fee schedule proposal would pay for remote physiologic and therapeutic monitoring only when a practice's own clinical staff furnish it, and would require an initiating visit.
Tip Detachment Risk Puts Medtronic Harmony Valve Catheter Lots in Class I Recall
Certain lots of the system used to place the Harmony transcatheter pulmonary valve may have a distal tip that detaches; the valve itself is not part of the recall.
FDA Early Alert Flags Medline Kits Containing Recalled BD ChloraPrep Applicators
Medline told customers to remove the affected skin-prep applicators from surgical convenience kits after BD recalled certain lots over a possible breach of sterile packaging.
FDA Publishes Proposed MDUFA VI Device User-Fee Recommendations
The draft deal with industry adds a fee for Pre-Submissions, a faster follow-up meeting type and a multi-regulator review pilot, with a public meeting set for August 5.