FDA digital health guidance
FDA guidance on digital health technologies in clinical investigations — the December 2023 DHT guidance on fitness for purpose, verification and validation, IDE and significant-risk determinations — together with the related guidance on decentralised clinical trials, AI/ML-enabled device software and medical device cybersecurity. The questions they ask are the ones a reviewer asks about your endpoint.
ALCOA++ in the Age of Digital Health Technologies (Part 5/8)
Can your audit trail reconstruct every DHT data transformation from source to submission? Are firmware, algorithms, and databases synchronised under one…
Read the article →Are Consumer Devices (e.g. Fitbits, …) Compliant for Endpoint Data Collection?
Can consumer wearables like Fitbits generate regulatory-grade clinical trial data? What risks arise when sponsors use consumer devices for endpoint…
Read the article →BYOD/eCOA in 2026: Timestamp Drift, Part 11/GDPR, and Audit Trails No One Wants to Own
What is “timestamp drift,” and how can a few minutes of clock deviation invalidate your eCOA endpoint data? Who actually owns the audit trail when…
Read the article →Best Practices for Usability Testing in DHTs
What makes usability testing a regulatory requirement for DHTs? How can poor usability compromise data integrity in decentralised trials? What are the most…
Read the article →DHT QMS: The Missing Link Between Mature Systems and Digital Health Readiness
Is your QMS framework prepared to manage device-level risk and traceability? How can sponsors extend quality oversight to digital endpoints without…
Read the article →Device Fit and Classification: When “Commercial” Becomes “Clinical” (Part 3/8)
Have you validated every DHT used in your trial for analytical, clinical, and usability accuracy? Are you certain of each device’s risk class in all…
Read the article →Endpoints and Algorithms: How Firmware Can Break Your Study (Part 4/8)
Can a single firmware update, algorithm change or data-sync failure invalidate months of trial data? How did the FDA’s DHT guidances change who answers for endpoint traceability and version control?
Read the article →Fit-for-Purpose or Bust: A Real-World Rubric for DHT Verification, Validation & Usability
What makes a DHT truly “fit-for-purpose” in a clinical trial context? How do verification and validation differ—and why does it matter? What role does…
Read the article →From Compliance Burden to Competitive Edge: How DHT Readiness Can Shorten the Path Through Review
Can building DHT compliance into trial design, rather than adding it later, mean fewer regulator questions and less rework? Is your compliance programme adding time to your timelines—or saving it?
Read the article →How to Survive – and Win – in the New Digital Health Economy (Part 8/8)
Is your organisation’s QMS built to manage devices, data, and endpoints together? Would your DHT-derived evidence survive a multi-country audit? Who in your…
Read the article →ICH GCP E6 Is Changing — And Digital Health Technologies Are at the Centre
For years, Digital Health Technologies lived slightly outside the GCP spotlight. Useful? Yes. Innovative? Absolutely. GCP-critical? Not always. ICH GCP E6 (R3) changes that.
Read the article →Meet the New Digital Health Reality: How to Make Your DHT Trials Regulator-Ready in 2026
Will your digital endpoints still hold up under regulatory scrutiny in 2026? Could you explain your DHT data pipeline to an inspector—without guessing? Are…
Read the article →Navigating AI Regulations: Insights on FDA’s AI/ML Guidance and the EU AI Act
How do the FDA's AI/ML guidance and the EU AI Act differ in regulating AI in life sciences? What challenges do life sciences companies face when complying…
Read the article →Navigating CE Marking and Global Compliance for DHTs in Clinical Trials
Does your CE mark actually protect you outside the EU? Most sponsors assume it does — until their US arm hits an IDE requirement. What happens when the MHRA…
Read the article →Roles Redefined: Manufacturer, Importer, System Producer — Which Are You? (Part 6/8)
Are you certain your organisation’s role under MDR or FDA law is correctly defined? Have you appointed authorised importers or representatives for DHT…
Read the article →Sponsor Oversight of Digital Health Technologies in Decentralised Clinical Trials: A Regulatory Guide
How do sponsors avoid becoming “accidental manufacturers” when deploying wearables in trials? What happens if a consumer-grade DHT fails to meet regulatory…
Read the article →The 2024 FDA DCT Guidance Decoded: 9 Operational Traps Sponsors Still Fall Into
What hidden operational traps are still tripping sponsors under the 2024 FDA DCT guidance? How can sponsors maintain investigator oversight across…
Read the article →The DHT Compliance Wake-Up Call: Why “Digital-Ready” Isn’t “Regulator-Ready” Anymore
Could you reconstruct any digital endpoint in your trial for an inspector—without opening PowerPoint? Is your DHT compliance actually regulator-ready, or…
Read the article →The DHT-Ready QMS: Integrating Device, Data, and Clinical Quality into One System (Part 2/8)
Does your QMS include design-history and validation records for every DHT you use? Are firmware, algorithms, and human-factors results governed under change…
Read the article →The Global Compliance Map: Deploying DHTs Across Borders (Part 7/8)
Are your DHTs classified and registered in every country where they’re used? Have you appointed local importers and authorised representatives? Do your…
Read the article →The Shockwave: What the FDA’s DHT Framework Really Means (Part 1/8)
Are your current DHTs validated for analytical, clinical, and usability accuracy? Who in your organisation owns responsibility for device version control?…
Read the article →When a Digital Health Tool Becomes a Medical Device: The Hidden Regulatory Roles No One Told You About
If your digital health tool is already collecting endpoint data, are you absolutely sure regulators don’t see it as a medical device? Who’s carrying the…
Read the article →“It’s Just a Phone”
Did you know a consumer smartphone can trigger four separate regulatory frameworks the moment it touches a clinical endpoint? Why do so many sponsors fail…
Read the article →A document appears here because it names FDA digital health guidance in its own text. Nothing is inferred: this is what we have actually written about it.