The Regulatory Desk https://theregulatorydesk.org/ Independent notes on how health products, clinic tools and patient rules are actually policed. Every note is built from a public record and links its primary source. en-us Sun, 20 Sep 2026 12:00:00 GMT https://www.rssboard.org/rss-specification The Regulatory Desk https://theregulatorydesk.org/logo.png The Regulatory Desk https://theregulatorydesk.org/ BlephEx, LLC: unresolved FDA warning letter https://theregulatorydesk.org/letter-725861.html https://theregulatorydesk.org/letter-725861.html Sat, 19 Sep 2026 12:00:00 GMT FDA FDA warning letter CMS 725861, issued to BlephEx, LLC on June 3, 2026: three eyelid devices, 177-plus complaints, and a repeat finding from a 2019 inspection. A randomised trial of the eyelid device found no benefit over sham https://theregulatorydesk.org/note-blephex-trial-2024.html https://theregulatorydesk.org/note-blephex-trial-2024.html Sun, 20 Sep 2026 12:00:00 GMT Devices & drugs A double-masked randomised trial of 42 patients, published in BMC Ophthalmology in 2024, found no significant difference between BlephEx treatment and sham. Repeat FDA warning: mold on sterile multi-use drug caps https://theregulatorydesk.org/letter-726714.html https://theregulatorydesk.org/letter-726714.html Sat, 19 Sep 2026 12:00:00 GMT Devices & drugs FDA warning letter CMS 726714 to Excelvision–Fareva, June 25, 2026: mold on sterile multi-use caps, recurring CGMP failures, and Import Alert 66-40. Nihon Kohden added alarm-silence after clearance, with no new 510(k) https://theregulatorydesk.org/letter-727803.html https://theregulatorydesk.org/letter-727803.html Sat, 19 Sep 2026 12:00:00 GMT Clinic software FDA warning letter CMS 727803 to Nihon Kohden Digital Health Solutions, June 12, 2026: an alarm-silence feature added after clearance, with no new 510(k). 3B Medical labeled a sleep device for reuse it was never cleared for https://theregulatorydesk.org/letter-725108.html https://theregulatorydesk.org/letter-725108.html Sat, 19 Sep 2026 12:00:00 GMT Devices & drugs FDA warning letter CMS 725108 to 3B Medical dba Reach Health, May 20, 2026: an APAP labelled for multi-patient reuse, and cloud software on a 2016 risk file. ZOLL under FDA warning for a nine-month-late device report https://theregulatorydesk.org/letter-711320.html https://theregulatorydesk.org/letter-711320.html Sat, 19 Sep 2026 12:00:00 GMT FDA FDA warning letter CMS 711320 to ZOLL Medical, April 30, 2026: defibrillators and MRI ventilators, complaints closed as user error, a report filed months late. Abbott shipped Libre 3 without the accuracy test FDA required https://theregulatorydesk.org/letter-722046.html https://theregulatorydesk.org/letter-722046.html Sat, 19 Sep 2026 12:00:00 GMT FDA FDA warning letter CMS 722046 to Abbott Diabetes Care, January 23, 2026: finished-device accuracy testing skipped after assembly, sterilisation and packing. Vohra paid $45 million after an EMR billed every debridement as surgery https://theregulatorydesk.org/note-vohra-2025.html https://theregulatorydesk.org/note-vohra-2025.html Sat, 19 Sep 2026 12:00:00 GMT Clinic software A Justice Department settlement of November 21, 2025: Vohra Wound Physicians paid $45 million over allegations its EMR billed every debridement as surgery. Diowave sold a “healing beam” outside the exemption FDA named https://theregulatorydesk.org/letter-712715.html https://theregulatorydesk.org/letter-712715.html Sat, 19 Sep 2026 12:00:00 GMT Devices & drugs FDA warning letter CMS 712715 to Technological Medical Advancements, September 26, 2025: claims beyond the infrared-lamp exemption and no design-history file. FDA: stop using unauthorized blood-pressure wearables https://theregulatorydesk.org/note-bp-unauthorized-2025.html https://theregulatorydesk.org/note-bp-unauthorized-2025.html Sat, 19 Sep 2026 12:00:00 GMT Advocacy FDA’s safety communication of September 16, 2025: do not use smartwatch or ring features that claim to measure blood pressure without FDA authorization. Practice Fusion sold opioid alerts, then paid $145 million https://theregulatorydesk.org/note-practice-fusion-2020.html https://theregulatorydesk.org/note-practice-fusion-2020.html Sat, 19 Sep 2026 12:00:00 GMT Clinic software A Justice Department resolution of January 27, 2020: an electronic health record vendor paid $145 million for selling clinical alerts to an opioid maker. The malpractice file you can download — and the one you cannot https://theregulatorydesk.org/note-npdb-public.html https://theregulatorydesk.org/note-npdb-public.html Sat, 19 Sep 2026 12:00:00 GMT Malpractice The National Practitioner Data Bank publishes malpractice payments as statistics, with names stripped by statute. It is not a query on a named practitioner. Who has to report a malpractice check https://theregulatorydesk.org/note-npdb-reporting.html https://theregulatorydesk.org/note-npdb-reporting.html Sat, 19 Sep 2026 12:00:00 GMT Malpractice Under Title IV, a payer reports a malpractice payment made for the benefit of a practitioner. An FDA warning letter to a manufacturer does not start that clock. Where a warning letter goes after FDA posts it https://theregulatorydesk.org/note-letter-travels.html https://theregulatorydesk.org/note-letter-travels.html Sat, 19 Sep 2026 12:00:00 GMT Malpractice Federal contracting decisions and export certificates may follow an FDA warning letter. A finding about a clinic’s day-to-day practice does not follow from it. The 483 you can read — and the reply you usually cannot https://theregulatorydesk.org/note-foia-reading-room.html https://theregulatorydesk.org/note-foia-reading-room.html Sat, 19 Sep 2026 12:00:00 GMT Advocacy FDA’s inspection observations are posted in the OII electronic reading room. The firm’s written reply usually is not, unless someone files a FOIA request. 177 complaints at FDA, none in the firm’s own file https://theregulatorydesk.org/note-medwatch.html https://theregulatorydesk.org/note-medwatch.html Sat, 19 Sep 2026 12:00:00 GMT Advocacy Anyone can report a device problem to FDA through MedWatch. Warning letter 725861 shows what the record looks like when a firm’s own complaint file was empty.