Issue No. 7 · Week of September 28, 2026
Two FDA field actions landed the same week the agency finalized MDUFA VI, which locks in a real fee gap for foreign registered manufacturing facilities. Washington also told federal agencies to start identifying Canadian origin products that could be dropped from federal procurement, a direct new front for anyone building product in Canada for the U.S. market. If you manufacture abroad and sell into the U.S. or Canada, this is a good week to check your exposure on both the FDA fee side and the federal procurement side.
Hospitals and Health Systems
Just three GPOs now serve more than 80 percent of US hospitals, study finds
Vizient, Premier and HealthTrust together served more than 80 percent of U.S. hospitals in 2024, up from about 62 percent a decade earlier, with Vizient nearly doubling its hospital count largely through acquisitions. Growing GPO concentration means landing on just a few national contracts increasingly determines access to most of the U.S. hospital market.
Source: Becker’s Hospital Review
Quebec’s new hospital procurement system draws political fire over cost
Quebec approved a new Financial and Procurement Information System meant to replace 41 separate finance and purchasing systems across the province’s health institutions, with reported cost estimates ranging from $329.4 million to nearly $1 billion. The winning contractor is already tied to a separate troubled government IT project, a sign Quebec hospital procurement may stay in flux and under heavier scrutiny over the coming year.
Source: Canadian Healthcare Technology
WakeMed-Atrium Health merger approved by Wake County, but draws state antitrust pushback
Wake County commissioners voted 5-2 to approve the merger, which still needs FTC and DOJ review and includes a five year cap on WakeMed price increases plus a $150 million community benefit fund. Days later, North Carolina’s Treasurer publicly called for the state Attorney General and FTC to scrutinize the deal, so a combined system covering the Triangle region may not consolidate purchasing until federal review clears.
Source: Becker’s Hospital Review
Federal Health Systems: VA and DoD
VA opens search for an integrator to unify VistA, Oracle Health and finance systems
VA issued a request for information, comments due October 2, for a technology integrator to connect its Community Care Network, its parallel Oracle Cerner and legacy VistA records, and a new financial and acquisition system into one operating model. Continued upheaval in VA’s core systems, alongside a consolidation from five community care regions to two, signals VA facility level purchasing and vendor onboarding could stay disrupted well into the transition.
Source: Washington Technology
Regulatory: FDA and Health Canada
FDA finalizes MDUFA VI fee schedule with higher costs for foreign manufacturing facilities
The finalized MDUFA VI commitment letter builds in a roughly $5,000 fee differential charging foreign device manufacturing facilities more than domestic ones, on top of a new $2,000 pre submission meeting fee credited toward future application fees. Companies that do not file U.S. tax returns also lose eligibility for small business fee reductions, locking in a real cost gap against U.S. based competitors.
Source: Mintz, FDA in Flux Newsletter
FDA flags reboot risk in React Health VOCSN ventilators tied to a loose cable connector
An early alert warns that an unseated internal flow transducer cable connector, especially after the unit is dropped, can trigger a reboot and a System Fault 10 alarm that stops therapy delivery. No deaths or injuries have been reported, but it is a reminder that a mechanical connector detail, not just software, can trigger a fleet wide FDA use advisory.
Source: FDA, Center for Devices and Radiological Health
FDA flags setup and button failures in Abiomed’s Automated Impella heart pump controllers
The early alert describes failures to recognize purge cassettes at setup, an unreliable selection button, and startup and software defects that could delay or degrade therapy. Abiomed, now part of J&J, is letting hospitals keep using affected units while it schedules hardware, firmware and software fixes.
Source: FDA, Center for Devices and Radiological Health
Health Canada warns of counterfeit laser devices circulating in Canadian clinics
Counterfeit versions of the Soprano diode laser system are being sold to clinics across Canada under falsified device licences and mislabeled manufacturer information. Health Canada is urging clinics to verify listings against the Medical Devices Active Licence Listing, worth noting for any legitimate device maker watching for forged versions of its own products.
Source: CP24, citing Health Canada
Import, Customs and Trade
Medtech Canada warns US memo targeting Canadian-origin products threatens device trade
A September 16 U.S. Administration memorandum directs officials to identify Canadian origin products that could be dropped from the federal civil procurement system, which Medtech Canada says was triggered by Canadian provincial procurement restrictions on U.S. companies. Canada exported about $2 billion in medical devices to the U.S. in 2023, about 75 percent of its device exports, while importing $4.8 billion from U.S. suppliers, so any Canadian based or Canada manufacturing device company should watch closely for an exclusion list or a reciprocal response.
Source: Medtech Canada, via Newswire
Also Noted
Four recent medical device maker cyberattacks
Becker’s rounds up four 2026 device maker cyberattacks, Stryker, Medtronic, Abbott and Boston Scientific, that disrupted manufacturing, shipping and order processing without touching device function.
Source: Becker’s Hospital Review
CMS eyes Medicare payment cuts for more than 1,100 lab codes
CMS’s preliminary 2027 lab fee schedule would cut payment on more than 1,100 of 1,528 test codes, with molecular and genomic testing facing the steepest reductions.
Source: Becker’s Hospital Review
Key Takeaways for Medical Device Manufacturers
This week’s developments put additional attention on the cost and procurement environment facing manufacturers selling into the U.S. and Canadian markets. Foreign registered manufacturing facilities should account for the higher costs outlined under MDUFA VI, while Canadian manufacturers selling into U.S. federal channels should watch closely for any procurement exclusions affecting Canadian origin products.
The continued concentration of U.S. hospital purchasing among a small number of GPOs also reinforces the importance of national contracting strategies, while the FDA and Health Canada actions highlight the need for strong postmarket controls, device traceability and monitoring for counterfeit products.
Questions About U.S. or Canadian Market Access?
Dawa Medical supports foreign medical device manufacturers entering the U.S. market as U.S. Agent, FDA Initial Importer and Importer of Record, with 3PL warehousing and regulatory compliance support. Through TB Medical Inc., manufacturers can also access Canadian importation and distribution support.
About The Access Brief: The Access Brief summarizes publicly reported news affecting medical device manufacturers selling into the United States and Canada and reflects Dawa Medical’s own understanding. It is not legal, regulatory or binding advice, and formal advice should come from qualified counsel or a specialist consultant.
