US FDA Medical Device and IVD Regulatory Strategy

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 to be sold in the US, while high-risk devices must go through the Premarket Approval (PMA) process prior to commercialization. Most manufacturers must also meet quality system requirements laid out in 21 CFR Part 820 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 US. Depending on your needs, our Global Regulatory Overview report service for the US medical device market covers topics such as:

  • Background on the FDA and CDRH regulations and applicability to your device
  • Product technology assessment
  • Medical device registration and premarket requirements
  • Estimated costs and timeframes for meeting the regulatory requirements
  • Labeling requirements
  • US regulatory roadmap and strategy overview
  • Device classification determination and predicate device assessment
  • FDA US Agent Representation for foreign manufacturers

Please contact us for more information about our Regulatory Overview and Strategy Support for the United States.

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