Medical device registration in the United States is overseen by the U.S. Food and Drug Administration (FDA) and involves multiple steps, which vary depending on the device classification.

Determine Device Classification:

The FDA classifies medical devices into three main classes (Class I, Class II, and Class III) based on their risk to patients and the level of regulatory control needed. Device manufacturers or distributors must first determine the classification of their device, as this determines the necessary regulatory pathway and requirements.

Establishment Registration:

The device manufacturer or distributor must then register their establishment with the FDA and list their device with the FDA, both of which are typically done through the Unified Registration and Listing System (FURLS).

Device Listing:

Device products are required to be listed with the FDA. Device listing provides specific information about the device, including its classification, intended use, and labelling. This information is also submitted through FURLS.

Premarket Notification 510(k) or Premarket Approval – PMA:

It’s important to note that while many Class I devices are eligible for 510(k) exemptions, not all Class I devices are exempt. Additionally, some Class II devices may also be eligible for exemption based on specific criteria.

Manufacturers should carefully review the FDA’s regulations and guidance documents to determine whether their device qualifies for a 510(k) exemption. If there is any uncertainty, it is advisable to consult with regulatory experts or directly contact the FDA for clarification to ensure compliance with regulatory requirements. The FDA regularly updates its guidance and regulations, so staying current with their guidance is essential.

510(k): Most Class II devices require a 510(k) submission, which demonstrates that the device is substantially equivalent to a legally marketed device -predicate and does not raise any new safety or efficacy concerns. Information on predicate devices are available on US FDA Database.

eSTAR: eSTAR is a free and mandatory, interactive PDF form that standardizes and streamlines the 510(k) submission process for most medical device submissions to CDRH and CBER, including combination products and Dual 510(k)/CLIA Waiver IVD submissions. It is voluntary for De Novo, 513(g) requests, PMA, and Pre-Submissions.

PMA: Class III devices, which are considered high-risk, require a Premarket Approval application. This involves submitting extensive scientific and clinical data to demonstrate the safety and effectiveness of the device.

Quality System Regulation (QSR) Compliance: Manufacturers must establish and maintain a quality system that complies with the FDA’s Quality System Regulation (21 CFR Part 820). This includes procedures for design control, production, labelling, and post-market surveillance.

Labelling and Label Approval: Medical device labelling must meet FDA requirements. Some devices may require premarket approval of labelling content.

Clinical Studies (if applicable): If your device requires clinical data to support its safety and efficacy, you will need to conduct clinical trials in accordance with FDA regulations.

User Fee Payment: Depending on the type of submission (e.g., 510(k), PMA), there may be user fees associated with the registration process.

FDA Review: The FDA reviews the submission to ensure it meets regulatory requirements. This process can take several months, depending on the complexity of the device.

FDA Clearance or Approval: If the FDA is satisfied with the submission and supporting data, they will issue either a 510(k) clearance or a PMA approval.

Post-Market Surveillance: After clearance or approval, manufacturers are required to monitor and report adverse events and other post-market information to the FDA.

Device Listing Updates: Keep device listings up-to-date with any changes to the device, labeling, or manufacturing processes.

It’s important to note that the registration process can be more complex for certain types of devices, such as combination products (e.g., drug-device combinations) or in vitro diagnostic devices.

The FDA’s website provides detailed information and guidance documents to assist in the registration process. Consulting with experts in regulatory affairs or seeking guidance from the FDA is advisable to ensure compliance with all applicable regulations and a successful registration process for your specific medical device.  RegTrac offers expert guidance in ensuring compliance with US FDA medical device regulations. Schedule a call today to discuss your needs!