FDA

Clinical Laboratory Improvement Amendments (CLIA)

Federal quality standards for US laboratories testing human specimens, administered by CMS with CDC and FDA under 42 CFR Part 493.

Clinical Laboratory Improvement Amendments (CLIA) and Clinical Genetic Testing

CLIA sets federal quality standards for clinical laboratory testing on humans, including genetic tests; CMS runs the program with FDA and CDC.

Common Rule (45 CFR Part 46) and IRB Oversight

HHS regulations at 45 CFR Part 46 protecting human research subjects and governing IRB review, overseen by the Office for Human Research Protections.

Contract Drug Manufacturing under cGMP

FDA current good manufacturing practice rules as they apply to contract drug manufacturers and to quality agreements between owners and contract …

Current Good Manufacturing Practice (CGMP) for Drugs

FDA current good manufacturing practice regulations for drug manufacturing, processing, packing and holding (21 CFR Parts 210 and 211).

Data Retention and Secure Destruction

Index of US federal sources on records retention and media sanitization, including HIPAA documentation rules, 21 CFR Part 11 and NIST SP 800-88.

Drug Supply Chain Security Act (DSCSA)

US law setting up electronic, interoperable tracing of prescription drug packages through the supply chain, implemented by the FDA.

FDA 21 CFR Part 11: Electronic Records and Electronic Signatures

FDA regulation, 21 CFR Part 11, setting criteria under which electronic records and electronic signatures are accepted in place of paper records.

FDA Artificial Intelligence-Enabled Medical Devices

FDA guidance and resources for medical devices with AI-enabled software functions, including predetermined change control plans (PCCPs).

FDA Device Software Functions and Mobile Medical Applications

FDA guidance on which software functions and mobile apps FDA regulates as medical devices and where it applies enforcement discretion.

FDA Quality Management System Regulation (21 CFR Part 820)

FDA's Quality Management System Regulation for medical device manufacturers, effective 2026-02-02, incorporating ISO 13485:2016 by reference.

Good Clinical Practice (ICH E6(R3))

International standard for the design, conduct and reporting of clinical trials (ICH E6(R3)), issued by FDA as final guidance in the US.

Medical Device Single Audit Program (MDSAP)

MDSAP lets one recognized auditing organization audit a device maker for the FDA, Health Canada, TGA, ANVISA and Japan's MHLW and PMDA.

Unique Device Identification (UDI): FDA and EU

Medical device identification rules requiring a UDI on labels, with device data in FDA's GUDID in the US and EUDAMED in the EU.