• Overview
• Content of Application
• Format of Application
• How to Submit an Application

Overview

Under the 510(k) Third Party Review Program, the FDA accredits potential 3P510k Review Organizations to conduct the review of 510(k) submissions for eligible devices. Potential 3P510k Review Organizations may apply to be an Accredited Person to review a broad range of device types or a specific device type. The FDA evaluates accreditation application packages based on criteria pursuant to Section 523 of the statute as well as the additional qualifications published in the Federal Register on May 22, 1998, as clarified in the FDA's guidance document 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.

Content of Application

1. Administrative Information:
   • Name and mailing address of 3P510k Review Organization seeking recognition
   • Full name, phone number, email address, and fax number of the contact person
     • Foreign organizations should also identify the name, address, telephone number, email address, and fax number of an authorized representative located within the U.S. that will serve as the 3P510k Review Organization's contact with FDA
   • Name and title of the most responsible individual at the 3P510k Review Organization
   • Brief description of the 3P510k Review Organization, including:
     • Type of organization (e.g., not-for-profit institution, commercial business, or other type of organization)
     • Size of organization (number of employees)
     • Number of years in operation
     • Nature of work (e.g., testing or certification laboratory)
     • Ownership, operation, and control of organization
   • Listing of any national, state, local, or other recognition
   • Listing of the device types the submitter is applying to review by product codes or classification regulation name and regulation. See List of Devices for Third Party Review page for a listing of eligible device types.
2. Prevention of Conflict of Interest:
   • Copy of the written policies and procedures established by the 3P510k Review Organization to ensure that the 3P510k Review Organization and its employees, external Technical Experts, contractors and individual contract employees involved in the evaluation of 510(k)s are free from conflicts of interest, and to prevent any individual or organizational conflict of interest, or appearance of conflict of interest that might affect the review process.
3. Personnel Qualifications:
   • Listing of personnel who will be involved in the preparation of the 3P510k Review Organization's 510(k) recommendations, including Product Specialists, Technical Experts, external Technical Experts, and Final Reviewers.  Submitters should show that these personnel are technically competent to conduct 510(k) reviews and should document the following in their application:
     • Written policies and procedures established to ensure 510(k)s are reviewed by qualified personnel;
     • Written instructions for the duties and responsibilities of personnel with respect to 510(k) reviews;
     • Written personnel standards established to ensure that designated personnel are qualified in all of the scientific disciplines presented by the 510(k)s for devices for which the 3P510k Review Organization is applying for its review;
     • Documentation (e.g., curricula vitae or CVs) to establish that the reviewers of 510(k)s (i.e., Product Specialists and Technical Experts) and other involved non-supervisory personnel meet the Recognition Criteria for qualified personnel.
     • Documentation (e.g., CVs) to establish that the supervisor(s) of 510(k) reviewers (i.e., Final Reviewer) have sufficient authority and meet the Recognition Criteria for qualified supervisory personnel. This includes documentation of education, training, skills, abilities, and experience, including specialized education and experience needed for the review of class II devices for which the 3P510k Review Organization is applying for its review; and
     • Description of the management structure, or, if an external technical expert is used for 510(k) reviews, the external Technical Expert's management structure. The application should describe the position of the individual(s) providing supervision within the management structure and explain how that structure provides for the supervision of 510(k) reviewers and other personnel involved in the review process.
4. Certification Statements:
   • Statement, signed by the most responsible individual at the organization, certifying that the 3P510k Review Organization has committed at the time of accreditation and at any time it is performing any 3P510k review that it will:
     • Report information that accurately reflects data reviewed;
     • Limit work and reviews to that for which competence and capacity are available, including conducting 510(k) reviews in accordance with the policies and procedures it has established regarding review of 510(k)s by qualified personnel;
     • Treat any information, records, reports, and recommendations that they may receive as proprietary and confidential information;
     • Respond and attempt to resolve complaints promptly regarding the activities for which it is recognized;
     • Protect against conflicts of interests in accordance with policies and procedures it has established relating to prevention of financial conflicts of interests, and annually make available to the public disclosures of the extent to which the person, and the officers and employees of the person, have maintained compliance with requirements relating to financial conflicts of interest;
   • The FDA also encourages the submitter to certify in its application that at all times, it will:
     • Demonstrate conformity while recognized by FDA with the requirements of the FD&C Act, section 523;
     • Maintain records consistent with Section VII.G Third Party Review Organization recordkeeping in 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations;
     • Comply with the eCopy requirements for premarket submissions as described in the guidance document eCopy Program for Medical Device Submissions;
     • Commit that their most responsible person or designee(s) will have completed FDA training prior to performing any reviews by the 3P510k Review Organization, and agrees that their most responsible person or designee(s) will attend such training when offered and applicable;
     • Contact FDA for early interaction before reviewing any subset of device type (by respective product code) that they have not reviewed as encouraged in Section VI.D in 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; and
     • Commit to only accepting reviews where the 510(k) Submitters certified that any relevant prior communications with FDA are disclosed.

Format of Application

Once the application is complete, the submitter should submit it as a single portable document format (PDF) file. The FDA encourages submission of an eCopy. The FDA intends to respond within 60 calendar days of the date of receipt of the application.

How to Submit an Application

Once the documentation has been turned into one PDF document, the applicant can submit it to:

[email protected];
Attention: CDRH Third Party Premarket Review Program

For more information about the content, format and how to submit an application, see Section VIII. Content and Format of an Application in 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.