MyRHC Compliance index

FDA

FDA Mobile Health App Compliance

Evaluate mobile medical app compliance with FDA guidance, 21 CFR Part 11, data security, clinical validation, and app store requirements

Telehealth & Digital Health Medtech Biotech & Life Sciences Healthcare Technology US

At a glance

Short name
mHealth Apps
Issuing / stewarding body
FDA
Jurisdiction
US
Also known as / related labels
FDA Mobile Medical App Guidance · 21 CFR Part 11 · HIPAA · GDPR · ISO 62304

What this entry covers

Evaluate mobile medical app compliance with FDA guidance, 21 CFR Part 11, data security, clinical validation, and app store requirements

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid — it is not legal advice and is not a substitute for the official text.

Official documentation

How to use this index entry

  1. Open the official link above (or the agency home if the deep link drifts).
  2. Confirm edition / revision date against your program scope.
  3. Map applicability by sector and jurisdiction listed in the metadata.
  4. Follow related frameworks only after checking their own official sources.

Disclaimers

  • MyRHC does not host proprietary standards text (ISO, some industry bodies).
  • Where standards are paywalled, we link to the publisher’s catalog page.
  • Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice. MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.

Same agencies or sectors — still verify each official source independently.

FDA AI/ML

Official

FDA AI/ML Software as Medical Device (SaMD)

Evaluate FDA AI/ML-based Software as Medical Device compliance per 2021 guidance, covering predetermined/adaptive algorithms, algorithm change …

FDA AI & Machine Learning Medtech

ISO 62304

Official

ISO 62304 Software Lifecycle Assessment

Evaluate medical device software development per ISO 62304:2006/AMD1:2015, covering software safety classification, development processes, risk …

International Standards Medtech

RPM

Official

Remote Patient Monitoring (RPM) Compliance

Evaluate remote patient monitoring program compliance covering CMS reimbursement, device accuracy, data transmission security, and clinical workflows

HHS Telehealth & Digital Health Healthcare

Contract Manufacturing (cGMP CMO) Compliance

Official

Assessment for pharmaceutical contract manufacturing organizations covering cGMP compliance, quality agreements, and third-party oversight

FDA Contract Manufacturing Pharma

FDA Part 11

Official

FDA 21 CFR Part 11 Electronic Records Compliance

Evaluate compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in FDA-regulated industries

FDA Healthcare Biotech & Life Sciences

FDA 820

Official

FDA 21 CFR Part 820 QSR Assessment

Evaluate compliance with FDA Quality System Regulation for medical device manufacturers - the U.S. equivalent of ISO 13485

FDA Medical Device Biotech & Life Sciences