US Medical Device Regulations

Key Regulations & Guidelines:

• Medical Device Reporting – 21 CFR Part 803
• Guidance on Medical Device Reporting for Manufacturers (2016)
• Investigational Device Exemption (IDE) – 21CFR Part 812
• Final Rule on eMDR – Electronic Medical Device Reporting – 21 CFR 803
• The Quality System (QS) regulation : 21 CFR Part 820