The US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) enforces a three-tier regulatory system for medical devices based on risk. Medium-risk devices typically require 510(k) Premarket Notification in order to be sold in the US, while high-risk devices must go through the Premarket Approval (PMA) process prior to commercialization. Many manufacturers must also meet quality system requirements laid out in 21 CFR Part 820 in order to market their devices in the US.
Let Emergo assist you in evaluating the US medical device regulatory framework as it applies to your device(s)
Emergo's worldwide network of consultants, industry sources and regulatory contacts enables us to develop in-depth and accurate analysis of medical device markets including the USA. Our Global Regulatory Overview report service for the American medical device market covers topics such as:
- Regulatory Background on the FDA and CDRH
- Product Technology Assessment
- FDA US Agent Representation
- Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- US Regulatory Roadmap
Please contact us for more information about our Regulatory Overview Report for the United States.