List of Supported Regulations

This list includes global regulations that USDM supports for our life sciences customers along with a link to the regulation for more information.*

We pride ourselves on staying current with the global regulatory landscape and are consistently at the forefront of driving change to keep up with technology.

Good Clinical Practices

• 21 CFR Part 11
• 21 CFR Par5 50
• 21 CFR Part 54
• 21 CFR Part 56
• 21 CFR Part 312
• 21 CFR Part 314
• Part 807 Estab. Reg. and Device Listing for Manuf. and Initial Importers of Devices
• 21 CFR Part 812 – Investigational Device Exemptions
• 21 CFR Part 814 – Premarket Approval of Medical Device
• The 510k & Premarket Approval (PMA) Guidance Document
• ICH E2A
• ICH E6 (R2)

GMP International Reference Guide

• 21 CFR Part 11
• Part 58 GLP
• Part 111 Dietary Supplement GMPs
• Part 210 Drug GMPs
• Part 211 Drug GMPs
• Part 820 Quality System Regulations
• ICH Q7 active Pharmaceutical Agreements
• ICH Q8 Pharmaceutical Development
• ICH Q9 Quality Risk Management (Guidance for Industry-FDA)
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical Quality System
• ICH Q11 Development and Manufacture of Drug Substances
• ICH Q12 Pharmaceutical Product Lifecycle Management (Draft)
• EU GMPs
• Canadian GMPs
• Japanese GMPs
• Australian GMPs

GMP Medical Device Reference Guide

• 21 CFR Part 11
• Part 801 Labeling
• Part 803 Reporting
• Part 806 Corrections and Removals
• Part 807 Estab. Reg. and Device Listing for Manuf. and Initial Importers of Devices
• 21 CFR Part 809 In-Vitro Diagnostic Products
• 21 CFR Part 810 – Medical Device Recall Authority
• 21 CFR Part 812 – Investigational Device Exemptions
• 21 CFR Part 814 – Premarket Approval of Medical Device
• Part 820 Quality System Regulations
• 21 CFR Part 821 – Medical Device Tracking Requirements
• 21 CFR Part 822 – Postmarket Surveillance
• 21 CFR Part 830 – Unique Device Identification
• Medical Device QSIT Manual
• PMA Premarket Approval and 510 (k) Guidance
• Inspection of Medical Device Manufacturers Program 7382.845
• Annex 11 Computerized Systems
• Annex 15 Qualification and Validation
• ICH Q9 Quality Risk Management (Guidance for Industry-FDA)
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical Quality System
• Canadian Medical Device Regulations – SOR/98-282
• ISO 13485 Quality Systems (Canadian Guidelines)
• 98/79/EC In Vitro Diagnostic Medical Devices
• 93/42/EEC Medical Device Directive Updated 2007/47/EC September 2007

*This is not an exhaustive list; for guidance on a regulation that is not listed, please contact usdm@usdm.com