US FDA clearance and approval

Do you intend to sell in US?

The US is the world’s largest medical device market. Medical devices marketed in the United States are subject to the regulatory controls by the U.S. Food and Drug Administration (FDA). With the focus on EU manufacturers who intend to sell in US, Meliora Compliance will help you to obtain the regulatory approval/clearance for your device in US.

We offer the following services:

  • Preparation of US regulatory pathway
  • Implementation, or upgrade of your quality system to be compliant with the FDA QS Regulation (21 CFR Part 820) and Medical Device Single Audit Program (MDSAP)
  • Working with your design and development team to make sure that development activities, including design verification and validation testing, are performed according to the US recognized standards and other applicable requirements
  • Preparation of 513(g) Request for Information on classification 
  • Preparation of Pre-Submissions and presence at meetings with FDA
  • Preparation of Investigational Device Exemption (IDE) submissions for US clinical study approvals
  • Preparation of request for the Breakthrough Device designation
  • Preparation of Safer Technologies Program (STeP) entrance request
  • Developing of a strategy to establish substantial equivalence (SE) for medical devices that require 510(k) submission
  • Creation of 510(k) submission for obtaining FDA clearance
  • Preparation and submission of De Novo request for classification
  • Creation and Premarket approval (PMA) submission
  • Creation of Humanitarian Use Device (HUD)/ Humanitarian Device Exemption (HDE) marketing application
  • Reviewing of IFU, labels and marketing materials to ensure compliance with regulatory requirements
  • Selection and appointment of US Agents for establishments based outside the US
  • Training on FDA QSR and on product-related submissions and clearances
  • Representation of establishments at QSR (21 CFR Part 820) inspections by FDA
  • FDA 483s and Warning Letter analysis, response, and recovery
  • Establishment registration and device listing in FURLS

Questions?
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