FDA guidance, policy shifts and enforcement that change what a submission needs, written for the team that has to file it.
FDA flagged the removal of Nova Biomedical's Gen 2.0 StatStrip hospital glucose meters as its most serious recall class on October 20. A barcode from a previous scan can stay on screen, filing a result under the wrong patient.
FDA published two hypothetical predetermined change control plans on October 20, one for a hospital-localized sepsis alert model and one for continuously learning arrhythmia software.
FDA expanded Import Alert 89-04 on October 20 to cover more Olympus devices made in Japan, including the Endocapsule small intestinal capsule set and two bronchovideoscopes.
Medtronic won a CE mark for its Vitalis pacemaker family, covering ReSyncra CSP, Restoria CSP, Refina CSP, Effectra and Confirma. The devices pace the heart's own conductive bundles rather than the ventricular wall.
The comment period on FDA's generative AI device discussion paper closed October 19. The paper proposes a two-axis risk framework and a premarket competency assessment built on non-clinical benchmarking followed by clinical confirmation.
FDA posted an early alert on October 15 about the Commander M delivery system used to implant the Edwards SAPIEN M3 mitral valve. Edwards has three reports of the balloon bursting during inflation, with one death and one serious injury.
Salvia BioElectronics said on October 15 that the first US patient has been implanted in RECLAIM-II, its trial of the MySalvia migraine neuromodulation system. The study will enroll about 150 adults with resistant migraine across more than 20 US sites under an FDA investigational device exemption.
FDA classified Avid Medical's removal of an IV start kit as Class I on October 14. The kit contains BD ChloraPrep applicators from a lot BD recalled for possible Aspergillus penicillioides contamination.
FDA sent Olympus a warning letter dated October 7 over quality system violations found at six facilities inspected in late 2025. Olympus says the letter does not restrict manufacturing or sales and requires no recalls.
Butterfly Medical won EU MDR certification for the Butterfly Prostatic Retraction Device, an implant for benign prostatic hyperplasia, on the back of a 244-patient trial. Its US premarket approval application is still with FDA.
Spiro Medical implanted its first patient in PULSAR, a feasibility study of spinal nerve stimulation for severe uncontrolled asthma. The study runs under an FDA investigational device exemption and will enroll up to 30 patients.
FDA issued an early alert on October 9 for the Philips Lumify handheld ultrasound. Philips reported eight serious injuries and four deaths as of September 29, tied to a software fault that demands re-registration and blocks scanning until it completes.
AdvaMed filed comments on October 9 asking CMS to make more breakthrough devices eligible for the RAPID coverage pathway and to let diagnostics in. Comments on the proposed notice close October 13.
FDA granted Breakthrough Device designation to Natera's multi-cancer early detection assay, the Austin company said October 9. The agency reviewed data across 12 cancer types before granting it.
Three 2023 De Novo grants became Class II regulations on October 9. Owlet's Dream Sock now sits at 21 CFR 870.2705, and its special controls are public text a follow-on 510(k) can be written against.
FDA approved an investigational device exemption on October 2, 2026 for Sonorous Neurovascular's B-SILENT 2 trial of the BosSTENT cerebral venous sinus stent. It is the first US trial of a venous sinus stent for pulsatile tinnitus, with enrollment expected in the fourth quarter.
FDA granted SeaStar Medical a Breakthrough Device designation for its Selective Cytopheretic Device in adults with sepsis, announced October 7. It is the seventh designation for the same platform.
FDA told O.N. Diagnostics to stop distributing version 3.0.0 of its VirtuOst VFA spine CT software because three separate changes each required a new 510(k). One was replacing the machine learning model that finds vertebral landmarks.
BD agreed on October 6 to invest $19 billion in US manufacturing in return for exemption from future Section 232 tariffs on its products. The exemption holds only if BD meets milestones neither side has disclosed.
The UK government accepted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare on October 6, 2026. The MHRA will monitor AI-based devices across their lifecycle rather than checking them once at approval.
FDA exempted 14 generic types of drug-of-abuse test system from premarket notification on October 6, effective immediately. The exemption applies only when the device is labeled solely for employment and insurance testing, and it now covers federal drug testing programs.
FDA published classification rules on October 6 creating Class II regulations for focused ultrasound mechanical ablation, hyperoxia monitoring and hereditary cancer sequencing panels. All three codify De Novo grants from 2023 and took effect the same day.
FDA approved NeuWire Medical's investigational device exemption for STROKE-REWIRE on October 5. The randomized, sham-controlled study will enroll up to 135 chronic ischemic stroke patients at up to 12 US sites starting in the first half of 2027.
FDA granted HeartBeam a Breakthrough Device designation on October 5 for assessing heart attacks outside the hospital. The Santa Clara company already holds two 510(k) clearances, both for arrhythmia assessment.
Control Bionics has CE marked NeuroStrip, its wearable surface EMG sensor, as a Class I device under the EU Medical Device Regulation. The mark opens the EU, the EEA and Northern Ireland, and leaves a TGA application in Australia as the last one outstanding.
The AMA CPT Editorial Panel approved a Category I code for implanting a subfascial tibial neuromodulation device, BlueWind Medical said on October 2. The code takes effect January 1, 2028.
FDA classified Draeger's removal of VentStar Resus Neo breathing hoses as Class I on October 2. The hose, model MP00310, serves infants up to 22 pounds and can crack or come off at a connection.
CDRH picked BD, Epitel, Prapela, Current Health and Skribe Medical as the first READI-Home participants on October 1. The challenge asks for home devices that keep discharged patients out of the hospital, and FDA plans nine participants by December 4.
CDRH published its fiscal 2027 guidance agenda on October 1, listing 11 final guidances and three drafts as A-list priorities. Comments are due November 30, 2026, under docket FDA-2012-N-1021.
FDA granted Breakthrough Device designation on October 1 to Medtronic's IN.PACT BTK, a paclitaxel-coated balloon for peripheral artery disease below the knee. No drug-coated balloon is approved for that territory in the US.
The AMA CPT Editorial Panel approved Category I codes for Medtronic's Symplicity Spyral renal denervation system and its Altaviva tibial neuromodulation implant, the company said October 1. Both take effect in January 2028, replacing Category III codes.
PearlMatrix P-15 began drawing a Medicare new technology add-on payment on October 1, Cerapedics said. NTAP covers up to 65 percent of the added technology cost on qualifying inpatient cases.
Japan's Ministry of Health, Labour and Welfare approved Optune Pax on October 1 for adults with unresectable locally advanced pancreatic cancer, used with gemcitabine and nab-paclitaxel. Approval rests on the Phase 3 PANOVA-3 trial.
BioCardia filed a revised De Novo pre-submission for its Helix cardiac delivery catheter on October 1, through FDA's Q-Submission program. The company says 15 clinical trials and nearly 500 patients sit behind the device.
WHO expanded medical device prequalification on September 30 to cover condoms, intrauterine devices and AI tuberculosis screening software. The program previously ran on in vitro diagnostics and male circumcision devices.
Autonomix Medical said on September 30 that a pre-submission meeting pointed its sensing platform to a Class II 510(k). The company is targeting US clearance in about 15 months.
FDA and the Medical Device Innovation Consortium held a joint public meeting at White Oak on September 25, 2026 on regulatory science gaps in device development. Docket FDA-2026-N-8563 takes comments until November 24, 2026.
FDA classified Boston Scientific's removal of Imager II angiographic catheters as Class I on September 25. Two serious injuries had been reported as of July 16, with no deaths, and complaint rates never rose.
CMS preliminary 2027 Clinical Laboratory Fee Schedule rates cut 775 test codes by the statutory maximum of 15 percent and touch close to 1,200 codes in all. Quest, Labcorp and the lab trade groups are pressing Congress to pass H.R. 5269, the RESULTS Act.
FDA published draft premarket guidance for robotically-assisted surgical devices on September 25. Comments are due November 24 under docket FDA-2026-N-9505.
CDRH will hold a hybrid public workshop on December 2 and 3 on robotic devices that run autonomously or under remote teleoperation. In-person registration closes November 23, and the agenda covers terminology, benefit-risk and policy.
FDA posted a Class I designation on September 24 for Becton Dickinson's correction to convenience kits and procedure trays holding recalled Huons sodium chloride ampules. BD reported no serious injuries or deaths.
The Molecular and Clinical Genetics Devices Panel voted 10 to 0 on safety, 6 to 4 on effectiveness and 7 to 2 with one abstention on benefit-risk for GRAIL's Galleri multi-cancer blood test on September 23, 2026. FDA is expected to decide on the PMA in the coming months.
FDA posted an early alert on September 23 covering 12 React Health VOCSN ventilator configurations. An internal flow transducer cable can work loose, rebooting the device and setting off recurring System Fault 10 alarms.
FDA posted an early alert on September 23, 2026 for three Automated Impella Controller configurations from Abiomed. A retrospective review of servicing records found units needing hardware, firmware or software updates. No serious injuries or deaths were reported as of September 8.
CMS released preliminary 2027 Clinical Laboratory Fee Schedule rates on September 21, 2026. More than 1,100 of roughly 1,500 tests with calculated rates would be paid less, and the agency puts annual savings near $1B. Final rates publish in November.
FDA posted materials on September 21 for a September 23 Molecular and Clinical Genetics Panel meeting on GRAIL's Galleri multi-cancer early detection test. GRAIL filed the PMA on January 29, 2026.
GAO report 26-108499, published September 21, says FDA has never audited four of the nine organizations accredited to review 510(k) submissions on its behalf, and has set no time frame for finishing an audit.
FDA updated the eSTAR submission templates on September 21. Both the IVD and non-IVD versions now carry the content of the human factors guidance published May 29 and effective August 1.
FDA classified CooperSurgical's removal of INCA infant nasal CPAP sets as a Class I recall on September 18, 2026. The tubing can loosen where it meets the nasal cannula, cutting pressure and oxygen delivery to newborns.
FDA classified NOxBOX's correction of the NOxBOXi nitric oxide delivery system as Class II on September 18, 2026. Oxygen tubing inside the NOxMixer module can fail or come loose, raising the delivered nitric oxide dose or interrupting therapy.
FDA issued draft guidance on September 18 introducing an electronic submission template for premarket approval applications and their supplements. Comments are due November 17 under docket FDA-2026-D-9429.
FDA published an order on September 17 denying a petition to exempt four categories of radiology AI software from premarket notification. Rubrum Advising filed it for Harrison.ai in October 2025; the agency denied it on April 1.
CDRH runs a one-hour virtual town hall on chemical characterization testing for biocompatibility on September 23, 2026. The topic is extraction methodology under ISO 10993-18 and the implementation problems FDA keeps seeing.
Philips Respironics discontinued the V60 and V60 Plus hospital ventilators after repeated corrections and recalls, with service running through December 2029. Mindray launched the SV70 on September 17, built to take Philips V60 accessories.
FDA awarded Cognita Imaging a $1.29 million, 18 month research contract to test whether a panel of large language models can score the output of another AI model across 1 million patient exams.
A Federal Register notice published September 16 sets a Microbiology Devices Panel meeting for November 19 on pathogen-agnostic sequencing, and opens docket FDA-2026-N-8692. Comments are due November 12, but only those filed by November 3 reach the committee.
CMS is adding heart failure, COPD, substance use disorder and tobacco cessation tracks to its ACCESS model. The model launches in spring 2027 with 160 participating organizations and a ten-year run.
FDA posted a Class I recall on September 15 for the Bravo CF capsule delivery device from Medtronic and Given Imaging. The agency counts 184 serious injuries and no deaths as of August 10, 2026.
CDRH listed a new Regulatory Reliance Portal for medical devices in its September 14 updates. It is built for other countries' regulators, gathering FDA clearance letters, PMA summaries, De Novo orders, inspection records and post-market data in one place.
FDA published a Paperwork Reduction Act notice on September 11, 2026 covering medical device tracking under 21 CFR Part 821. It now estimates 662,906 annual hours across about 22,000 firms, up 47,526 hours from the last estimate. Comments close November 10, 2026.
FDA recognized ISO 10993-1:2025 in May 2026 but carved out clause 6.9 on biological risk estimation, saying the text lacks the specificity to implement. Manufacturers can keep citing the 2018 version until July 1, 2029.
FDA published a final order on September 11, 2026 creating 21 CFR 870.2380 for cardiovascular machine learning-based notification software. The class traces back to the Viz HCM De Novo that FDA granted Viz.ai on August 3, 2023.
CMS finalized its reconsideration of the TAVR national coverage determination on September 10, 2026. Asymptomatic severe aortic stenosis is now covered under coverage with evidence development, and the CED requirement for symptomatic patients is gone.
FDA published eight device classification regulations on September 10, all effective the same day. Each turns a 2023 De Novo grant into a codified Class II regulation with special controls, which opens a 510(k) route for the next company with the same device type.
FDA published a clear dental aligners page on September 9, 2026 stating that it has not authorized any aligner sold directly to consumers without a prescription. Every cleared aligner is a prescription device under product code NXC, to be used under a licensed dental professional's supervision.
The FDA classified GE HealthCare's correction for Portrait Core Services software as Class II on September 3, 2026. A software update could remove patients from Portrait Mobile monitoring and reset alarm settings to factory defaults.
FDA confirmed a Class I recall on September 3, 2026 covering roughly 1,079 unused Boston Scientific Infinion CX spinal cord stimulation leads. The company reported 1,081 serious injuries as of May 27, 2026.
Boston Scientific asked customers on August 24, 2026 to remove all Imager II angiographic catheters after finding reduced levels of stabilizing agents in the tips. The company will discontinue the product rather than correct it.
FDA issued final guidances on September 1 for 510(k) submissions covering dental composite resin devices and dental curing lights, with the Federal Register notice on September 2. They replace guidances from October 2005 and March 2006 and finalize drafts from July 2024, with changes to shelf-life testing and to how curing light output is measured.
FDA released the discussion paper Considerations for the Regulation of Generative AI-Enabled Medical Devices on August 18, 2026 under Docket FDA-2026-N-7874, with comments due October 19. It floats a two-axis risk grid, a competency-based assessment modeled on clinician credentialing, and a voluntary master file for foundation models.
FDA published fiscal year 2027 medical device user fee rates on July 30, 2026, effective October 1. The standard 510(k) fee rises to $28,653 and the small business rate to $7,163, while the establishment registration fee climbs to $13,785 with no small business discount.
FDA posted the draft MDUFA VI commitment letter on July 8, 2026, covering fiscal years 2028 through 2032. It steps the average 510(k) total time from 128 days down to 112, adds a 45-day Focused Follow-Up pre-submission, and creates a not grantable letter for De Novo requests.
FDA posted warning letters on June 30, 2026 to BMC Medical and 3B Medical, both dated May 20 and both stemming from a December 2025 inspection. FDA said firmware changes adding new detection algorithms to devices cleared under K153387 required a new 510(k), and that a shipped firmware fix was never reported as a correction.
FDA issued a closeout letter to Whoop on June 17, 2026, ending the July 14, 2025 warning letter over Blood Pressure Insights. The agency said it does not intend to enforce device requirements against the modified product, citing changes Whoop made and its own revised general wellness guidance from January 6, 2026.
FDA issued the final guidance Content of Human Factors Information in Medical Device Marketing Submissions on May 29, 2026, finalizing a December 2022 draft. It assigns each submission to one of three HF categories, and eSTAR added a matching drop-down effective August 1, 2026.
MHRA published the draft Medical Devices (Amendment) Regulations 2026 and opened a stakeholder impact survey on May 11, 2026, closing June 19. The draft creates an international reliance route recognising approvals from Australia, Canada and the United States, and adds a predetermined change control plan pathway for software.
CMS and FDA announced the RAPID coverage pathway on April 23, 2026. CMS would issue a proposed national coverage determination on the day FDA grants marketing authorization, putting Medicare coverage roughly two months out instead of a year or more. About 40 devices qualify today.
The Quality Management System Regulation replaced the Quality System Regulation in 21 CFR Part 820 on February 2, 2026, incorporating ISO 13485:2016 by reference. FDA retired QSIT the same day and began inspecting against compliance program 7382.850, which opens management review, internal audit and supplier audit records to investigators.
On January 6, 2026 FDA issued revised final versions of its Clinical Decision Support Software and General Wellness guidances, skipping the usual comment period. Software giving a single clinically appropriate recommendation can now fall outside device oversight, and wearables estimating blood pressure, oxygen saturation or glucose can be sold as wellness products.
The Commission adopted COM(2025) 1023 on December 16, 2025, a targeted revision of the MDR and IVDR. It would remove maximum certificate validity, move some software and reusable instruments to lower classes, cut notified body fees for micro and small manufacturers, and create designated pathways for orphan and breakthrough devices. The Commission estimates savings above 3 billion euros a year.
FDA published the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot in the Federal Register on December 8, 2025 under Docket FDA-2025-N-6461. Up to about ten U.S. manufacturers per clinical area can offer digital health devices to CMS ACCESS model participants without premarket authorization, in exchange for real-world data and a plan to seek clearance.
Commission Decision (EU) 2025/2371, published in the Official Journal on November 27, 2025, confirmed that the actor registration, UDI and device registration, notified bodies and certificates, and market surveillance modules of EUDAMED become mandatory on May 28, 2026. Devices already on the market have until November 27, 2026 to complete UDI registration.
The federal shutdown that began October 1, 2025 ended November 12 after 43 days, the longest on record. During the lapse FDA could not accept new device submissions requiring a user fee, while reviews already paid for continued on MDUFA carryover balances.
FDA issued the draft guidance Quality Management System Information for Certain Premarket Submission Reviews on October 27, 2025 under Docket FDA-2025-D-4051. It replaces a 2003 document and rebuilds what PMA and HDE applicants file around the QMSR taking effect February 2, 2026.
From October 1, 2025, FDA accepts De Novo classification requests only as eSTAR submissions sent through the CDRH Portal. The requirement was set in an August 2024 final guidance and follows the October 2023 eSTAR mandate for 510(k)s.
FDA issued the final guidance Computer Software Assurance for Production and Quality System Software on September 24, 2025, three years after the draft. It supersedes Section 6 of the 2002 General Principles of Software Validation and scales assurance work to the risk each software tool carries.
FDA published a final rule on September 19, 2025 removing the laboratory developed test language it added to 21 CFR 809.3 in May 2024. The action implements the March 31, 2025 vacatur by a federal court in Texas, a decision FDA chose not to appeal.
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