FDA’s December 2025 RWE Guidance and Latin American Clinical Data: A New Strategic Window for Medical Device Sponsors

In December 2025, the FDA finalized an update to its 2017 guidance on the use of real-world evidence (RWE) in medical device regulatory submissions. The revision is narrow on paper but strategically significant: the FDA no longer always requires sponsors to submit or secure access to identifiable individual participant-level data when using real-world data sources to support an IDE, 510(k), De Novo, PMA, or HDE submission. Aggregate, de-identified, and privacy-restricted data sources are now acceptable with appropriate justification.

For MedTech sponsors running first-in-human and early-feasibility clinical trials in Latin America, this shift creates a new strategic window — one worth understanding before your next regulatory conversation with the FDA.

What Changed in the December 2025 Guidance

The 2017 guidance effectively expected sponsors to obtain patient-level records when using real-world data sources — a high bar when the underlying data came from registries, hospital systems, or health databases outside the US that operated under privacy rules limiting sponsor access. The December 2025 revision explicitly acknowledges that reality and redirects the evaluation toward a different question: whether the evidence is scientifically sound and fit for purpose, regardless of whether the sponsor can access every underlying record.

Three practical shifts flow from this:

• De-identified and aggregate datasets are now usable. Sponsors no longer need to demonstrate access to identifiable records when privacy rules forbid it, as long as data relevance, reliability, and traceability are documented.
• International data sources are explicitly addressed. The FDA recognizes that privacy and legal frameworks outside the US (GDPR, Latin American data protection laws, regional privacy statutes) may limit participant-level sharing — and says so directly.
• The burden shifts to transparency. Where participant-level data are unavailable, sponsors must clearly document what data are available, who has access, and how limitations affect the results.

The guidance still applies only to medical devices. The parallel drug and biologics RWE guidance remains unchanged for now, with an FDA statement that updates are under consideration.

Why This Matters for Latin American Clinical Data

Latin America has spent the last decade becoming a practical venue for FIH and early-feasibility medical device trials. The region offers 40% faster regulatory approval timelines, 30% lower overall trial costs, and ethics-committee turnaround of 4 to 8 weeks against 6 to 12 months in the US and EU. Clinical data generated in the region are already accepted by the FDA under 21 CFR 812.28 when ICH-GCP compliance is documented.

What the December 2025 guidance adds is a second, complementary path: real-world evidence sourced from Latin American healthcare systems, registries, and post-market data — data that was previously awkward to incorporate into US submissions because of cross-border privacy restrictions. Under the new guidance, a MedTech sponsor can now more credibly combine:

• A prospective FIH or early-feasibility study conducted under ICH-GCP at accredited Latin American sites, producing the core safety and effectiveness data;
• Supporting real-world evidence drawn from regional hospital registries, payer databases, and post-market surveillance — including aggregate-only sources — to strengthen external validity, capture long-term outcomes, or support indication expansion.

Strategic Implications for MedTech Founders

For founders and regulatory directors planning a device program, the December 2025 revision opens three concrete strategic options:

• Smaller, faster pivotal studies. When aggregate RWE can support effectiveness or safety endpoints, prospective sample sizes can sometimes be reduced, shortening enrollment timelines and cost.
• Stronger post-market commitments. FDA post-market surveillance obligations can increasingly be satisfied with regional registry data and claims-like datasets from Latin American health systems, rather than expensive prospective US post-approval studies.
• Indication expansion without re-running a full trial. When a device is approved for one indication, RWE from real-world use in Latin American hospitals can support label expansion submissions with a much smaller prospective component.

What You Need to Get Right

The FDA is not lowering the scientific bar. The agency explicitly reinforced that relevance and reliability remain the core evaluation criteria. Practically, sponsors planning to use Latin American RWE in a submission should:

• Prespecify the protocol. Define in writing how the RWE data source will be used, what endpoints it supports, and how missing data will be handled — before any analysis runs.
• Document data provenance. Source systems, extraction dates, curation steps, and validation activities must be traceable. When patient-level access is not available, this documentation burden increases.
• Address bias and confounding explicitly. Sensitivity analyses, transparent endpoint definitions, and prespecified analytic assumptions are essential.
• Validate key data elements. Device exposure capture (through UDIs or alternative approaches), clinical outcomes, and covariates must be validated against a gold standard where feasible.

Frequently Asked Questions

Does the December 2025 FDA guidance apply to drug or biologic submissions?
No. The current revision applies to medical device submissions only. The FDA has indicated that it intends to consider parallel updates for drugs and biologics, but those have not been finalized. Drug sponsors should continue to engage the FDA early on a case-by-case basis when proposing RWE approaches.

Can I use a Latin American hospital registry as a real-world data source for an FDA device submission?
Yes, provided the data are relevant to the population, exposure, and outcomes of interest, and reliable in terms of generation, curation, processing, and validation. The December 2025 guidance explicitly accepts aggregate and de-identified data sources when participant-level access is restricted by local privacy law, so long as sponsors transparently document those limitations.

How does this guidance interact with 21 CFR 812.28 for prospective trials?
The two frameworks are complementary. 21 CFR 812.28 governs acceptance of prospective clinical investigations conducted outside the US, requiring ICH-GCP compliance. The December 2025 RWE guidance governs acceptance of real-world data — registries, claims, electronic health records — that are not generated through a prospective clinical trial. A well-designed Latin American regulatory strategy can now use both pathways in a single submission.

bioaccess® is a contract research organization purpose-built for first-in-human and early-feasibility medical device trials, operating across 10 Latin American countries with a 12-month timeline guarantee. Learn more at bioaccessla.com or book a strategy conversation at bioaccessla.com/book-a-meeting.