Life Sciences Compliance in North America: QMSR, MDEL, and LDTs

On February 2, 2026, the US Food and Drug Administration retired a regulation that had governed device manufacturing since 1996. The Quality System Regulation is gone, replaced by the Quality Management System Regulation, and every device maker selling into the United States now operates under ISO 13485:2016 incorporated directly into federal law. Two weeks later, across the border, Health Canada published the final version of a separate overhaul that removes a licensing requirement for foreign distributors while adding a new annual disclosure obligation nobody had to meet before.

Neither change was optional, and neither arrived with a grace period long enough to feel comfortable. For regulatory affairs teams tracking both the FDA and Health Canada, 2026 is not a year of incremental guidance. It is a year in which two of North America's most established device frameworks were rebuilt at the same time, alongside a court ruling that erased an entire diagnostic testing rule and a pre-authorization pathway that is quietly changing how AI-enabled devices reach the market.

Here is what actually changed, what is still pending, and what a compliance team operating across the United States and Canada needs to track through the rest of 2026.

What changed when the FDA's QMSR took effect on February 2, 2026?

The Quality Management System Regulation replaced the 1996 Quality System Regulation at 21 CFR Part 820 by incorporating ISO 13485:2016 directly by reference, along with Clause 3 of ISO 9000:2015 for shared vocabulary. The final rule was published February 2, 2024, giving manufacturers exactly two years to transition, and FDA did not offer an enforcement discretion period once the effective date arrived.

The scope of Part 820 did not change: it remains the binding device current-good-manufacturing-practice requirement under FD&C Act Section 520(f). What changed is the reference standard itself, plus a set of FDA-specific supplements that layer on top of ISO 13485, including the Section 820.3 definitions, labeling and packaging controls, complaint handling, CAPA, and UDI record-retention requirements that are not covered by ISO 13485 alone. For combination products, FDA made conforming edits to 21 CFR Part 4 Subpart A, so a device-constituent quality system must meet the QMSR baseline even though an ISO 13485 certificate by itself does not demonstrate QMSR compliance.

Inspections changed alongside the rule. On February 2, 2026, FDA retired the Quality System Inspection Technique it had used for three decades and began inspecting under the updated Compliance Program 7382.850. Any PMA or HDE application still pending on the effective date needed to demonstrate QSR compliance if filed before February 2, 2026, and QMSR compliance if filed after, which forced sponsors filing in late 2025 to make a hard call about which standard to build toward.

Did FDA's electronic submission mandate change again in 2026?

Electronic submission requirements kept moving even as the QMSR consumed most of the industry's attention. eSTAR has been mandatory for 510(k) submissions since October 1, 2023, and became mandatory for De Novo classification requests on October 1, 2025. On June 1, 2026, FDA released a major version update, eSTAR 7.0 and preSTAR 3.0, with a transition date of August 3, 2026 after which new submissions are expected to use the updated templates.

The user-fee cycle funding the review process is also in transition. MDUFA V runs through September 30, 2027, and FDA-industry negotiations for MDUFA VI began in August 2025, with a public meeting held to discuss changes to the Total Product Life Cycle Advisory Program. Sponsors planning multi-year submission strategies should not assume the current fee structure or review-timeline commitments will carry unchanged into MDUFA VI.

What happened to FDA's plan to regulate laboratory developed tests?

It was struck down, and then withdrawn entirely. FDA's May 2024 final rule would have brought laboratory developed tests under medical device oversight by redefining in vitro diagnostic products to include tests manufactured by a laboratory. The American Clinical Laboratory Association and the Association for Molecular Pathology sued, and on March 31, 2025 the US District Court for the Eastern District of Texas vacated the rule, ruling that clinical laboratory testing services are not devices under the Federal Food, Drug, and Cosmetic Act and that a laboratory performing such services is not a device manufacturer.

FDA let its appeal window close on May 30, 2025 without filing, and on September 19, 2025 issued a new final rule formally rescinding the 2024 regulation, reverting 21 CFR 809.3(a) to its pre-2024 language. Laboratory developed tests are once again regulated primarily through CLIA certification administered by the Centers for Medicare and Medicaid Services rather than through FDA premarket review, and any compliance deadlines that labs had been tracking under the vacated rule no longer apply. This is exactly the kind of regulatory reversal that is easy to miss if a team is monitoring FDA guidance pages alone rather than the underlying litigation docket. Obsidian tracks the litigation and the rescission together on one regulatory timeline, so a compliance lead sees the vacatur, the rescission, and the CLIA fallback in sequence rather than as three disconnected headlines.

How does FDA authorize changes to AI-enabled devices without a new submission each time?

Through the Predetermined Change Control Plan, a mechanism Congress created via the Food and Drug Omnibus Reform Act that lets a sponsor pre-authorize specific future modifications inside the original marketing submission. FDA finalized its PCCP guidance for AI-enabled device software functions on December 3, 2024, and followed with implementation recommendations on August 18, 2025. The mechanism applies across all three device pathways, 510(k), De Novo, and PMA, and is the structural fix for adaptive algorithms that FDA's older locked-algorithm expectations could not accommodate.

A separate draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, covers the fuller total-product-lifecycle documentation FDA expects for AI-enabled submissions, including risk assessment, bias mitigation, and postmarket performance monitoring. It remains in draft status and sits on CDRH's lower-priority guidance list for 2026, meaning firms are building submissions against expectations that could still shift before finalization. Sponsors filing AI-enabled devices need a live view of which FDA guidance is final and binding versus draft and directional, since submitting against outdated assumptions on either side of that line creates avoidable review delay.

What is changing for medical device importers and distributors in Canada?

Health Canada finalized the second phase of its Medical Device Establishment Licensing modernization on June 17, 2026, publishing SOR/2026-110 in the Canada Gazette, Part II. The amendments come into force December 14, 2026, exactly 180 days after publication, and change three things at once. Foreign distributors no longer need their own Medical Device Establishment Licence if they sell exclusively through a Canadian importer that already holds one, a change intended to align Canada with the United States, the European Union, the United Kingdom, and Australia. Retailers and health care facilities that import directly without a licence still have to verify that the foreign distributor they buy from holds one.

In exchange for that relief, every MDEL applicant and holder must now submit a supplier list, including each supplier's name, address, and the risk classification of the devices they supply, and update that list annually at the licence review. The prior attestation model for documented procedures, covering distribution records, complaint handling, and recalls, is replaced with an explicit, standalone regulatory obligation. Companies with pending MDEL applications when the amendments take effect must add supplier information before Health Canada will issue the licence. Businesses relying on a foreign distributor's separate MDEL should reassess their supply chain structure now rather than in November, since the compressed six-month window leaves little room to renegotiate distribution agreements after the fact.

Is Canada about to overhaul its clinical trial framework too?

A proposal is on the table, though it is not yet law. Health Canada published draft Clinical Trials Regulations in the Canada Gazette, Part I, on December 20, 2025, aiming to replace the existing drug clinical trial regime under Part C, Division 5 of the Food and Drug Regulations and the separate COVID-19 Clinical Trials Regulations with a single, risk-based framework. The stated goal is to reduce regulatory burden for lower-risk trials while preserving oversight for higher-risk ones, and to make Canada more attractive for international trial sponsors.

The public consultation, originally set to close March 20, 2026, was extended to April 19, 2026 to give stakeholders more time to comment on both the draft regulations and the accompanying guidance documents, including new guidance on decentralized clinical trials. Once Health Canada finalizes the regulations and publishes them in the Canada Gazette, Part II, they come into force twelve months later. Sponsors running or planning trials in Canada should treat the current Part C, Division 5 regime as fully in effect until that Part II publication happens, while watching for the "what we heard" report that will signal how much the final framework diverges from the December 2025 draft.

What should a North America compliance team do next?

Confirm the QMSR transition is complete, not just planned, since FDA is inspecting against Compliance Program 7382.850 now and there is no enforcement grace period left to invoke. Map every pending 510(k), De Novo, or PMA submission against the eSTAR 7.0 transition date of August 3, 2026, and check whether any Canadian supply relationship depends on a foreign distributor's standalone MDEL that will need restructuring before December 14, 2026.

Doing this by hand across two regulators, four framework versions, and an active court docket is exactly where teams lose days to information that changed weeks earlier. Obsidian tracks FDA and Health Canada updates jurisdiction by jurisdiction, with alerts the moment a final rule, a rescission, or a Canada Gazette Part II publication lands, so compliance leads spend their time on the decision rather than the discovery. For teams already stretched across MDR, IVDR, and QMSR simultaneously, Obsidian's AI companion can answer a specific question, such as which of your active submissions falls under the pre- or post-February 2026 QMSR line, against the same verified source records used throughout this article. Compliance and regulatory-affairs functions building internal tooling on top of that data can pull it programmatically through the MCP, and teams comparing plans can start with jurisdiction-level monitoring for exactly the US and Canada slices covered here.