US FDA Medical Device Registration, 510(k) and PMA submissions

In the United States Medical Devices are regulated by FDA’s Center for Devices and Radiological Health (CDRH) and encompass anyone who manufactures, repackages, relabels, and/or imports medical devices sold in the United States.

The type of medical device registration required depends on the class of device. Medical devices are classified into 3 categories based on the risk of use, with Class I being the least risky, and Class III being the most. For this reason, regulatory control increases with each class.

  • Class I: Most Class I medical devices can be self-registered. This path typically takes 1 month
  • Class II: Most Class II medical devices require a 510(k) submission. This path typically takes 6-9 months
  • Class III: Most Class III devices require a Pre-Market Approval (PMA) submission. This path typically takes 18-30 months

Our Services

  • Evaluate the classification of your medical device and determine the proper FDA product code and regulation number
  • Preparation of a Medical Device Establishment Registration and Listing
  • Facilitate interaction with regulatory agencies, during development stages, submissions and submission approval process
  • Liaison with regulatory agencies on regulatory, CMC, clinical and toxicology matters
  • Determine which similar (predicate) devices already have FDA 510(k) clearance and whether they are suitable for use in your 510(k) submission.
  • Review testing requirements, applicable FDA guidance documents and required standards.
  • Provide a detailed product-specific list of documents needed for review by our 510(k) consulting team.
  • Provide a detailed list of documents, reports, diagrams or clinical data needed before 510(k) preparation can begin.
  • Prepare a technical comparison of your medical device to other predicate devices with FDA 510(k) clearance
  • Preparation of Premarket Notification 510(k) Submissions
  • Preparation of Premarket Approval (PMA) Submissions
  • Applications for an Investigational Device Exemption (IDE)
  • Current Good Manufacturing Practices (cGMP) Audit and Review
  • Medical Device Reporting (MDR)
  • Medical Device Label Review for compliance with 21 CFR Part 801

Contact our medical device specialists using the form for support with your FDA medical device registrations