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Expert guidance on FDA MAUDE monitoring, post-market surveillance automation, regulatory strategy, and AI-powered compliance for medical device teams.
No. The FDA is building AEMS to consolidate its adverse event systems, and it replaced FAERS on the drug side in March 2026. Devices have not moved. MAUDE is still the source of record, and openFDA still serves it.
Recalls citing 'Under Investigation by firm' fell to 5 in the week of August 10–17, 2026, a fraction of the trailing 8-week weekly average. But the product mix — diagnostics, infusion sets, dental implants and vascular access — shows the label 'under investigation' can mask urgent patient-facing risks.
Seven recalls posted between August 3 and August 10, 2026 pushed Orthopedic Manual Surgical Instruments to 7.0 times their trailing 8-week weekly average, with two distinct root causes — subcontractor machining failures and sterile barrier compromise — driving the spike.
Recalls naming 'Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component' devices hit 7 in the week of July 27–August 3, 2026, running at 7.0 times the trailing 8-week weekly average. Five of those seven records name the same failure mode: cracking of carbon fiber connecting rods after reprocessing.
Recalls naming duodenoscopes and accessories reached 6 in the week of June 29–July 6, 2026, six times the trailing 8-week weekly average, with at least five citing the same sterile packaging breach issue across a CRE wireguided balloon dilator line.
Recalls citing package design or selection as the root cause reached 12 in the week of June 27–July 4, 2026, a 12.0x spike above the trailing 8-week weekly average. Five of those recalls share a single failure mode: potential sterile breach of device pouches.
Everything medical device professionals need to know about the FDA MAUDE database, from search strategies to overcoming its well-known limitations.
AI and NLP are reshaping how medical device companies detect safety signals, classify adverse events, and meet regulatory obligations under FDA and EU MDR requirements.
Why systematic monitoring of competitor adverse events gives medical device companies a strategic edge in regulatory planning, market positioning, and risk management.
Periodic Safety Update Reports are essential under EU MDR but notoriously time-consuming. Learn what can be automated and what still needs human judgment.
The FDA is consolidating its adverse event databases into AEMS. Drugs moved first; devices are named in scope but have not migrated. Here is what is coming for medical device companies and how to prepare.
The FDA will eventually move device adverse event data into AEMS. It has not yet. Here is how to set up your SOPs, monitoring and PSUR baselines now so the cutover costs you a day instead of a month.
Devices have not migrated to AEMS, and the openFDA device/event endpoint is still the live source — weekly refreshes, roughly 25 million records, no deprecation. A technical look at the endpoint today, what a cutover would change under the hood and why archiving raw responses now protects your audit trail later.
FDA is connecting its Elsa AI assistant to consolidated submission data. Here is what the agency has actually confirmed, what is still only trade coverage and why traceability is the real gap for device teams.
Post-market surveillance breaks where volume outgrows attention. Reading faster, hiring another analyst or narrowing scope only delays the moment the method fails. What to automate, and what to leave with your team.
Stop manually searching FDA databases. Get AI-assisted adverse event monitoring, provisional reports with retained evidence and weekly digests.
