The USA is a large market for medical devices and has its own regulations for regulatory approval. Here are some important aspects of these regulations:
- Title 21 CFR Part 820: This part of the Code of Federal Regulations specifies documentation and quality management system (QMS) requirements. In many areas, Title 21 CFR Part 820 is like ISO 13485, but there are also important differences.
- MDSAP: This programme was introduced to simplify the auditing and approval of medical devices. In addition to the USA, other countries participate in MDSAP, including Japan, Canada, Australia, and Brazil. Other countries that follow the MDSAP concept (so called affiliate members) are Argentina, South Korea, and Singapore.
- 510(k): This refers to premarket notification for Class II and higher medical devices. Manufacturers must submit a 510(k) notification to the Food and Drug Administration (FDA) to demonstrate that the device is safe, effective, and not substantially different from devices already on the market.
- 513(g): This regulation describes the process for classifying medical devices in the US. Manufacturers can submit a 513(g) request to the FDA to obtain information about the classification of a particular device.
If you are looking to market medical devices in the US, it is important to follow these regulations. We can help you understand the requirements and successfully navigate the approval process. Contact us for more information and assistance.
