Regulatory must reads: FDA’s policy pivot – impacts of CDRH ‘leveling up’ use of guidance documents

Hal Stowe, Senior Manager, Regulatory Intelligence, Eurofins Medical Device Services

In the US, FDA guidance documents shape how regulated industries understand Agency expectations, policy shifts, anticipated data, and sometimes enforcement authorities. The guidance process also provides an opportunity for public comment on proposed updates—an important public-private mechanism to protect patients while mitigating innovation bottlenecks. When that process is bypassed, uncertainty often
follows.

In Q1 2026, FDA’s Center for Devices & Radiological Health (CDRH) signaled a notable shift: using Level II guidance to make substantial updates to existing regulatory frameworks— creating near- and long-term implications for MedTech.

Level II guidance explained

FDA guidance is governed by Good Guidance Practices (21 CFR 10.115), which define categories (Class I and Class II) and prescribe FDA procedures for development and issuance.

Level I guidance addresses interpretations of statutory or regulatory requirements, significant changes to those interpretations, complex scientific matters, and/or highly controversial issues.

Level II guidance sets forth existing practices or minor changes in interpretation or policy; it also includes documents not classified as Level I.

Level I guidance generally uses draft guidance with public comment. Level II is typically issued faster, with limited stakeholder input; updates are effective immediately (or as specified). The distinction is illustrated by the Jan 6, 2026 updates to Clinical Decision Support Software and General Wellness: Policy for Low Risk Devices. The changes were substantial, which many stakeholders viewed as more consistent with Level I processes. The choice of Level II signals a shift in CDRH’s mechanism for updating policy, aligning with the Administration’s deregulatory agenda.

The shift & its implications

These guidance areas have long attracted varied interpretations about applicability and enforcement. Against that backdrop, CDRH’s use of Level II guidance—bypassing public comment—is notable for avoiding stakeholder-driven clarification. This is especially visible in the General Wellness update, where added interpretive scenarios appear to conflict with prior understandings. On issuance, FDA Commissioner
Makary said the intent was, “to cut unnecessary regulation and promote innovation,” consistent with an overarching deregulatory agenda. In practice, this approach all but eliminates the ability to issue Level I guidance, pushing CDRH toward faster, less procedurally burdensome mechanisms that omit industry comment.

Key policy areas affected

Sponsors should track three key areas affected by CDRH’s shift in guidance policy:

1. Clinical Decision Support (CDS) software: the update significantly narrows the scope of software regulated as a medical device.
   1. Introduces enforcement discretion for certain functions that provide a single “clinically appropriate” recommendation.
2. General wellness products: updates expand products exempt from FDA regulation, allowing non-invasive wearables that measure variables such as blood pressure and blood glucose to be marketed for general wellness without premarket review.
3. Real-world evidence: final guidance on real-world evidence is expected in FY2026.

CDRH’s full FY2026 guidance agenda is available here.

Impact on startups and commercial-stage companies

For startups, Level II guidance is a double-edged sword. For Digital Health & Wellness products, reduced barriers may lower market-entry costs and accelerate time-to-revenue. But without public comment, expectations can shift with minimal notice, creating regulatory risk that is often intolerable for startups with limited risk-absorption capacity.

For commercial-stage sponsors, CDRH’s agenda signals direction but is not definitive. Regulatory intelligence becomes essential: track CDRH updates, assess potential impacts, and audit existing CDS or General Wellness claims against revised guidance. When applicability is unclear, sponsors should use
external resources to support near-term compliance and long-term strategy.

In this environment, regulatory policy feels like a gray area. For startups and commercial-stage companies navigating this uncertainty, regulatory intelligence must be corporate infrastructure. Eurofins’ regulatory intelligence and policy experts are your guide in navigating the nuance of current, and future, Level II guidance. That expertise, partnered with our leading medical device testing capabilities, takes strategy beyond the bench. For more information, Contact Us at: Medical-Device@BPT. EurofinsUS.com.