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FDA Draft Guidance on 510(k) Third Party Review Program and Emergency Use Authorization Review: Content and Format | FDA

The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.

FDA medical devices exemption class II

Table of content

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.

Once finalised, the guidance will provide an overview of the applicable regulatory requirements and additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to comply with it.

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.

Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework. It has been agreed with the authority in advance. 

The present document provides the guidelines set forth by the FDA for organizations seeking initial recognition or rerecognition as a Third Party 510(k) Review Organization (3P510k RO).

According to the document, these organisations play a critical role in the premarket review process for medical devices, and the guidance outlines the requirements and procedures for achieving and maintaining this status.

Application Process for Initial Recognition

First, the document describes the process for applying for the initial recognition. Organisations aiming to become recognised as 3P510k ROs must submit their applications to the FDA via email or mail.

The submission should include comprehensive administrative information, such as the organisation’s name, contact details, description, and a list of device types for review.
The FDA expects the application to be in a single portable document format (PDF) and encourages an additional electronic copy submission for more accessible review.

Once the application is received, the FDA will respond within 60 calendar days with a decision or a request for additional information. Respond timely to such requests to avoid the denial of recognition.

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Critical Components of the Application

The document further outlines the main elements of the application to be submitted by an interested party. According to the document, the application must cover several critical areas, namely:

  • Administrative Information: This includes basic organisational details, the contact person’s information, and a brief description of the organisation’s nature, size, years in operation, and other recognitions or certifications.
  • Conflict of Interest Prevention: The organisation must provide policies and procedures to ensure its personnel and contractors are free from conflicts of interest.
  • Personnel Qualifications: A list of all personnel involved in the 510(k) review process should be provided, including their qualifications, responsibilities, and management structure. Ensuring that these individuals are technically competent for the reviews they conduct is vitally important.
  • Certification Statements: Organizations must certify their commitment to accurate reporting, confidentiality, conflict of interest prevention, and compliance with FDA guidelines.
    They should also ensure their personnel receive appropriate FDA training and comply with specific FDA guidance documents.

Recognition Process

The scope of the guidance also covers the aspects related to the re-recognition process. Following the applicable regulatory requirements, for continued approval beyond three years, 3P510k ROs must seek rerecognition.

The application for re-recognition follows a similar format to the initial application, and the FDA evaluates the organisation’s past performance and any relevant audit information.
Applications for re-recognition should be submitted at least 60 days before the expiration of the current recognition to avoid lapses.

If an organisation’s application for recognition or re-recognition is denied, it can request reconsideration under specific FDA regulations and appeal processes.

Key FDA Expectations and Requirements

To assist the parties involved in interpreting and following the applicable regulatory requirements, the document further highlights the critical expectations established by the authority.

According to the document, the FDA emphasises the need for thoroughness, transparency, and adherence to set guidelines throughout the process.
It is vitally essential for 3P510k ROs to maintain a high standard of review quality and technical competency and to manage any potential conflicts of interest.

The guidance outlines a structured and detailed application process to ensure only qualified and capable organisations undertake the critical task of the 3P510k review.

Conclusion

In summary, this guidance issued by the FDA provides a comprehensive framework for organisations seeking to obtain or renew their status as 3P510k ROs.
It emphasises the importance of organisational structure, conflict of interest prevention, personnel qualifications, and adherence to FDA standards and procedures.

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