Framework

V3 + DiMe

Verification · analytical · clinical

Documentation

End-to-end

Methods, evidence, version history

Submission

Supported

IND · IDE · NDA · BLA · MAA

Built for regulatory review, not just data collection

Regulatory-Ready
Digital Endpoints

Regulatory-ready endpoints are not a marketing label. They are digital measures developed using correlation, training, verification, and validation methodologies aligned with FDA, EMA, and DiMe practices — documented end-to-end so they can stand up in a submission package.

Talk to Delve Explore Wearables

V3-aligned · Documented · Submission-ready

FDA

EMA

DiMe

Regulatory Endpoint Workflow

Define → Validate → Document → Submit

Will the FDA accept the wearable data as evidence?

Acceptance depends on how the endpoint was developed and documented — not on the device. Delve's V3-aligned package gives reviewers what they're looking for.

Method first. Metric second. That's what review teams care about.

Method first. Metric second. Aligned with FDA / EMA / DiMe practice

What 'Regulatory-Ready' Actually Means

A regulatory-ready digital endpoint is one whose method, validation, and provenance are documented end-to-end — to a level that supports its inclusion in a regulatory submission. The phrase is not about the device, the vendor, or the dashboard. It is about the paper trail.

Verification: documented evidence that the sensor measures what it claims to measure
Analytical validation: evidence that the algorithm computes correct values on labeled data
Clinical validation: evidence that the metric reflects the clinical outcome of interest
Submission package: a bundle of method, validation evidence, change history, and example outputs ready for inclusion

Regulatory readiness is a property of the documentation — not the device.

Related pages: Validation · Digital Endpoints

Regulatory-ready digital endpoint pipeline with documented validation evidence

Why Digital Endpoint Submissions Stall

Most digital endpoint submissions stall not because the underlying technology is unsound, but because the validation evidence is missing, partial, or not packaged in a reviewable way.

Black-box algorithms

Reviewers can't accept a metric they can't explain. Opaque vendor algorithms are a hard stop.

Validation gaps

Verification done; analytical validation thin; clinical validation absent. Submissions need all three.

No version history

An algorithm that changes silently mid-study leaves reviewers unable to trust comparisons over time.

Provenance loss

Values arriving without device, firmware, and algorithm-version context can't be re-analyzed.

Misalignment with intent

Strong validation against the wrong clinical question doesn't help the submission.

Late documentation

Documentation written after the trial is harder to defend than documentation built alongside it.

Submission readiness is something you build in from the beginning — not bolt on at filing time.

Delve Regulatory Approach vs Traditional Wearable Programs

Traditional wearable programs

Vendor-defined algorithms
Patchy validation evidence
Algorithm history not tracked
Documentation assembled at filing time
Provenance not preserved

Delve regulatory-ready approach

Documented, versioned algorithms
V3-aligned verification + analytical + clinical validation
Change history maintained over the study lifetime
Documentation built alongside the trial
Provenance preserved with every value

We don't replace your regulatory team — we give them an organized, defensible package.

What a Strong Regulatory Endpoint Package Includes

Endpoints that hold up under review are packaged for review — not just collected.

Endpoint definition: protocol-aligned description of what the measure represents
Three-layer validation evidence: verification, analytical, clinical
Version history: full changelog with rationale for each release
Example outputs: representative data with provenance fields
Re-analysis procedure: documented steps for reviewers who want to reproduce results

When the package is organized, the conversation with reviewers stays focused on the science.

See related pages: Security & Privacy · Validation · Endpoint APIs

Regulatory-ready digital endpoint package with validation evidence and version history

Aligned With Current Regulatory Expectations

Delve tracks the frameworks reviewers actually use — and updates validation patterns as those frameworks evolve.

FDA Digital Health CoE

Methodology aligned with current FDA guidance for digital health technologies in clinical trials.

EMA qualification advice

Endpoint methods take EMA qualification opinions and scientific advice into account.

DiMe V3 framework

Verification, analytical, and clinical validation patterns follow the Digital Medicine Society V3 framework.

21 CFR Part 11

Electronic records and signatures handled in a 21 CFR Part 11-compliant infrastructure.

GCP

Endpoint operations follow ICH GCP principles for clinical investigation.

Audit support

Immutable audit trail, scoped access, and documented procedures for inspections.

We support — we don't replace — your regulatory team. The submission still belongs to your filers.

FAQ

Will the FDA / EMA accept this digital endpoint?

Acceptance is decided per submission. What Delve provides is a documented, defensible package that contains the evidence reviewers ask for. Your regulatory team owns the submission strategy.

How is this different from a 'validated' consumer wearable?

Consumer 'validation' typically refers to the sensor. Regulatory-ready digital endpoints require validation of the full chain — sensor, algorithm, and clinical meaning — documented in a way reviewers can audit.

Can Delve attend regulatory meetings with us?

Yes. We'll join pre-submission meetings or sponsor briefings to walk through the digital endpoint package if that helps your regulatory team.

Regulatory-Ready Digital Endpoints