US FDA Medical Device Regulations & Guidelines
We have assembled the public documents below as a service to the medical device community. Although we do our best to ensure that these documents are the latest versions, things change. If you would like to suggest a document for inclusion or we have included an outdated version, please let us know. All documents were published by the US Food and Drug Administration and are in PDF format unless otherwise noted.
Design Control Guidance for Medical Device Manufacturers
Text related to FDA 21 CFR 820.30 and sub-clause 4.4 of ISO 9001.
Food, Drug and Cosmetic Act
Section of Act as it relates to medical devices including Chapter 5, Subchapters A & E.
Labeling for Medical Devices
Guidance on medical device labeling from the FDA.
Quality Systems Regulations (QSR)
US FDA QSR regulation and Good Manufacturing Practices (GMP).
Post Market Surveillance
Guidance on criteria and approaches for medical device post-market surveillance.
Human Factors in Medical Device Design
Discusses the CDRH push to have manufacturers apply Human Factors to device design.
User Fees
Summary of FDA fees for 2008 thorugh 2012.
