The Regulatory Desk https://theregulatorydesk.org/ The authoritative source for no-nonsense analysis of regulatory issues. Independent notes on FDA warning letters including BlephEx, clinic software, malpractice files, and the rules on devices and drugs. en-us BlephEx, LLC: unresolved FDA warning letter https://theregulatorydesk.org/letter-725861.html https://theregulatorydesk.org/letter-725861.html Tue, 07 Jul 2026 00:00:00 GMT Notes on the public FDA warning letter dated June 3, 2026 to BlephEx, LLC of Brentwood, Tennessee. Repeat FDA warning: mold on sterile multi-use drug caps https://theregulatorydesk.org/letter-726714.html https://theregulatorydesk.org/letter-726714.html Thu, 25 Jun 2026 00:00:00 GMT Nihon Kohden added alarm-silence after clearance, with no new 510(k) https://theregulatorydesk.org/letter-727803.html https://theregulatorydesk.org/letter-727803.html Fri, 12 Jun 2026 00:00:00 GMT 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 Wed, 20 May 2026 00:00:00 GMT ZOLL under FDA warning for a nine-month-late device report https://theregulatorydesk.org/letter-711320.html https://theregulatorydesk.org/letter-711320.html Thu, 30 Apr 2026 00:00:00 GMT Abbott shipped Libre 3 without the accuracy test FDA required https://theregulatorydesk.org/letter-722046.html https://theregulatorydesk.org/letter-722046.html Fri, 23 Jan 2026 00:00:00 GMT 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 Fri, 21 Nov 2025 00:00:00 GMT Diowave sold a “healing beam” outside the exemption FDA named https://theregulatorydesk.org/letter-712715.html https://theregulatorydesk.org/letter-712715.html Fri, 26 Sep 2025 00:00:00 GMT FDA: stop using unauthorized blood-pressure wearables https://theregulatorydesk.org/note-bp-unauthorized-2025.html https://theregulatorydesk.org/note-bp-unauthorized-2025.html Tue, 16 Sep 2025 00:00:00 GMT 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 Mon, 27 Jan 2020 00:00:00 GMT 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 Tue, 09 Sep 2026 00:00:00 GMT Who has to report a malpractice check https://theregulatorydesk.org/note-npdb-reporting.html https://theregulatorydesk.org/note-npdb-reporting.html Tue, 09 Sep 2026 00:00:00 GMT Where a warning letter goes after FDA posts it https://theregulatorydesk.org/note-letter-travels.html https://theregulatorydesk.org/note-letter-travels.html Tue, 09 Sep 2026 00:00:00 GMT 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 Tue, 09 Sep 2026 00:00:00 GMT 177 complaints at FDA, none in the firm’s own file https://theregulatorydesk.org/note-medwatch.html https://theregulatorydesk.org/note-medwatch.html Tue, 09 Sep 2026 00:00:00 GMT