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