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
- 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