US Medical Device Consensus Standards
Links to applicable US Consensus Standards
- Web Version of ISO 13485:2016(en) Medical devices — Quality management systems — Requirements for regulatory purposes
- Web Version of IEC 62304:2006(en) Medical device software — Software life cycle processes
- Web Version of IEC 82304-1:2016(en) Health software — Part 1: General requirements for product safety
- Web Version of IEC 62366-1:2015(en) Medical devices — Part 1: Application of usability engineering to medical devices
US Medical Device Regulations
Links to applicable US FDA Regulations
- U.S. FDA Title 21, Chapter I, Subchapter H Part 800 General
- U.S. FDA Title 21, Chapter I, Subchapter H Part 801 Labeling
- U.S. FDA Title 21, Chapter I, Subchapter H Part 803 Medical Device Reporting
- U.S. FDA Title 21, Chapter I, Subchapter H Part 806 Reports of Corrections and Removals
- U.S. FDA Title 21, Chapter I, Subchapter H Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
- U.S. FDA Title 21, Chapter I, Subchapter H Part 814 General Premarket Approval of Medical Devices
- U.S. FDA Title 21, Chapter I, Subchapter H Part 820 Quality System Regulations
- U.S. FDA Title 21, Chapter I, Subchapter H Part 821 Medical Device Tracking Requirements
- U.S. FDA Title 21, Chapter I, Subchapter H Part 822 Post Market Surveillance
- U.S. FDA Title 21, Chapter I, Subchapter H Part 830 Unique Device Identification
- U.S. FDA Title 21, Chapter I, Subchapter H Part 860 Medical Device Classification Procedures
Links to FDA Guidance and Regulatory Updates
Quality and Compliance (Medical Devices) - A good starting point for the FDA's Medical Device Quality and Compliance Tools
FDA Guidance Documents - Database search engine for guidance documents (draft and final) applicable Medical Devices and Radiation Emitting Devices under the Center for Devices and Radiological Health (CDRH)
Class II Special Controls Documents - Class II devices are those devices for which special controls, combined with general controls, are needed to provide assurance of safety and effectiveness. The documents listed under this link elaborate the special controls for the applicable Class II devices.
These documents describe how such devices may comply with the requirement of special controls. The risks to health identified in these documents must be addressed.
Quality Management System Regulation (QMSR) Final Rule - amending current good manufacturing practices (CGMP's) of 21 CFR 820 and incorporating ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes) by reference. This update goes into effect 2 February 2026.
Center for Devices and Radiological Health (CDRH) Compliance Programs - FDA updated Compliance Program Guidance Manual (CPGM) for the Inspection of Medical Device Manufacturers
Design Control Guidance For Medical Device Manufacturers - From March 1997, but still the core quality & regulatory requirements for medical device manufacturers that design their own products.
21 CFR 820.30 defines the requirements; this guidance document elaborates on those requirements.
Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff - This guidance is intended to assist medical device manufacturers in preparing and maintaining a QMS and provide the information expected regarding the Quality System as part of Certain Premarket Application Reviews following implementation and effectivity of the QMSR, 2 February 2026.
Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff - Recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
If you have computerized systems that automate or store quality system data, this guidance identifies various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff - Applicable to devices with cybersecurity considerations, not limited to devices that include a device software function or that contain software (including firmware) or programmable logic.
The guidance is not limited to devices that are network-enabled or contain other connected capabilities. This guidance describes recommendations regarding the cybersecurity information to be provided for device premarket submissions when submitted to the Center for Devices and Radiological Health (CDRH).
Electronic Submission Template for Medical Device Q-Submissions - Draft guidance document introduce submitters of Q-Submissions (Q-Subs) to the Center for Devices and Radiological Health (CDRH) to the current resources and associated content developed and made publicly available to support certain Q-Sub electronic submissions to FDA.
Q-Submissions are pre-submission interactions initiated by industry stakeholders to obtain FDA feedback before submitting formal regulatory applications for medical devices. These interactions are part of the FDA’s Q-Submission Program, which include:
- Pre-Submissions (Requests for FDA feedback before a formal submission (e.g., 510(k), PMA)
- Other Q-Sub types such as 513(g) requests (means for device manufacturers to obtain information about the Food and Drug Administration’s views regarding the classification of a device), informational meetings, and study risk determinations.