【EXPERT Q&A】What is the FDA registration review process for medical devices?

February 26, 2024  Source: drugdu 95

Drugdu.com expert's response:

The FDA registration review process for medical devices involves the following key steps:

1.Determine Product Classification: Firstly, the classification of the medical device needs to be determined, i.e., identifying which category it falls under in the FDA's classification system. FDA categorizes medical devices into three classes: Class I, Class II, and Class III. The registration review process and requirements may vary depending on the device's classification.

2.Prepare Registration Application: Prepare a comprehensive registration application package according to FDA requirements, including product description, technical specifications, design files, clinical trial data (if applicable), quality management system documentation, manufacturing process documentation, etc.

3.Submit Registration Application: Submit the complete registration application package to the FDA. Typically, this is done through the FDA's electronic registration system, the FDA Unified Registration and Listing System (FURLS).

4.Registration Review: The FDA reviews the submitted registration application. During the review process, the FDA may request further information or clarification on aspects of the application.

5.On-Site Inspection: Depending on the circumstances, the FDA may conduct an on-site inspection to verify whether manufacturing facilities, quality management systems, etc., comply with FDA requirements.

6.Review Outcome: The FDA makes a decision based on the review outcome. If the registration application is approved, the FDA issues a registration certificate, permitting the device to be marketed and used in the United States. If the registration application is denied, the FDA provides reasons for the denial along with necessary guidance. Applicants can make adjustments and reapply as needed.

In summary, the FDA registration review process for medical devices involves multiple stages, including preparation of application materials, submission, review, on-site inspection, and decision-making. Applicants must strictly adhere to FDA requirements and guidelines and maintain communication with the FDA to ensure a smooth application process.

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