On November 21st, the Food and Drug Administration (FDA) released final guidance for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review processes, which clarifies how the FDA will use third party review organizations (ROs) to review 510(k) submissions and EUA requests during a public health emergency. The guidance provides guidance on the FDA’s conduct of both the 510(k) Third Party Review Program and EUA third party review, including guidance on device eligibility and procedures for 510(k) Third Party Review Organizations, and expectations for Third Party review to ensure quality, consistency, and conflict prevention.

Background

The 510(k) Third Party Review Program (3P510k Program) began in 1996 when the FDA launched a voluntary third party 510(k) review pilot program for selected medical devices. The pilot program was codified and expanded by the Food and Drug Administration Modernization Act in 1997. Only class I and II medical devices are eligible for the 3P510k Program.

In 2017, the FDA Reauthorization Act of 2017 (FDARA) was signed which required the FDA to issue guidance on the factors the agency will use to determine which class I and II device types are eligible for review by 3P510k ROs, including the risk of the device type, whether the device type is permanently implantable, life sustaining, or life supporting, and whether there is public health justification for review by an accredited individual. The 3P510k Review Program makes for a more rapid decision process for 510(k) device manufacturers by allowing third party ROs to review low-to moderate risk devices so the FDA can focus its internal scientific review resources on higher risk, complex devices. A 3P510k RO must be recognized by the FDA under section 523(b) of the FD&C Act to be eligible to participate in the Review Program. The review process for the 3P510k program is straightforward:

  1. ROs review a 510(k) submission and forward their review package which includes their review memo, the submission, and their recommendation to the FDA.
  2. The FDA then reviews the RO’s memo and recommendation and makes the final decision within 30 calendar days after receipt of review package.
  3. The FDA informs the RO and the 510(k) Submitter of their final decision.

The COVID-19 pandemic created the need for a different type of third party review, namely, emergency use authorization (EUA) reviews given the large amounts of EUA requests from manufacturers to review diagnostic products to detect SARS-CoV-2.  In response, the FDA contracted with third parties to provide third party EUA Review (3PEUA). In December 2022, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) was signed into law which clarified the FDA’s authority regarding use of third party review organizations to conduct initial reviews of EUA requests for in vitro diagnostic products and directs the FDA to issue guidance on such third party review procedures. The primary purpose of the 3PEUA review process is to enable to the FDA to rapidly expand its resources to review EUA requests related to medical devices if the Secretary of Health and Human Services (HHS) has made a declaration of emergency or threat justifying authorization of emergency use (an “EUA declaration”), authorizing the emergency use of an unapproved product[1]. The FDA may establish a contractual relationship with one or more qualified 3PEUA ROs to conduct such reviews in a timely manner. In general, the FDA intends for EUA requests to be submitted directly to FDA and then the FDA may forward the EUA request to 3PEUA ROs, as appropriate. But to respond quickly and increase access in certain emergency situations, the FDA may determine that public health would be better served by having submitters send certain EUA requests for in vitro diagnostic products directly to a 3PEUA RO instead. The 3PEUA review process differs from the 3P510k Review Program in several ways. Some of the main differences are:

  • 3PEUA review may only occur following a relevant declaration under section 564 of the FD&C Act justifying emergency use authorization of a product. Assignment of a EUA request will be determined at FDA’s discretion.
  • EUA Submitters should send EUA requests directly to FDA, and FDA may decide to send certain EUA requests to a 3PEUA RO for review. For in vitro diagnostic products, FDA may determine that the public health would be better served by having submitters send EUA requests directly to a 3PEUA RO.
  • The FDA may contract with 3PEUA ROs directly. This includes the review of EUA requests for in vitro diagnostic products where FDA determines it would be appropriate to send EUA requests directly to a 3PEUA RO.
  • 3PEUA ROs will be identified based on expertise and skills needed in anticipation of or at the time of an emergency declaration; FDA does not anticipate selecting 3PEUA ROs in advance of an emergency declaration under section 564 of the FD&C Act.

Summary of Final Guidance

This final guidance contains several expectations and current thinking on key aspects of the 3P510k Review Program and 3PEUA review. The FDA breaks down their objectives into six components which are summarized below:

  1. The Factors Used in Determining Device Type Eligibility in the 3P510k Review Program
    • The risk of the device type, or subset of such device type: The FDA generally classifies medical devices based on the risks associated with the device type and devices are classified into one of three regulatory classes: class I, class II, or class III. Class III devices are not eligible for 3P510k review.
    • Whether the device type, or subset of such device type, is intended to be permanently implanted in the human body, to sustain human life, or to support human life: An RO must provide a detailed public health justification explaining why this device type should be eligible for 3P510k review according to section 523(a)(3)(B)(i)(II) of the FD&C Act and how this will positively impact public health.
    • The extent to which the device type is well understood: For example, devices with novel technological characteristics, including some devices requiring complex special controls initially classified through the De Novo process may be ineligible for 3P510k review.
    • The extent to which necessary information to make a well-informed recommendation is available to 3P510k ROs: A device type may be ineligible for 3P510k review if information relevant to evaluating a device type cannot be shared outside the agency (e.g., it is proprietary).  
    • The extent to which the review of the device type does not require multifaceted, interdisciplinary expertise: For example, the review of some kinds of clinical data or complex non-clinical data (e.g., computational modeling) or a combination product or device type either of which requires review from another Center in the Agency would likely be ineligible for 3P510k review due to the need for such expertise.
    • The availability of postmarket data suggesting that the device type is the subject of safety signals: For example, if a device type is the subject of a safety communication, a high-risk recall (Class I) or postmarket data that indicate a safety signal, this device type may be ineligible for 3P510k review.
    • The FDA will consider each of these factors to determine device type eligibility for 3P510k review. The FDA may determine that a submission is ineligible for 3P510k review if a device type that was considered eligible for review received a proposed modification to the device type that raises different concerns related to the factors listed above.
  2. Review of 510(k) Submissions or EUA Requests by Third Party Review Organizations

The FDA expects Third Party Review organizations to conduct FDA-equivalent reviews on devices and are responsible for reviewing and analyzing scientific and technical data in their submission when making recommendations to the FDA. The following steps describe the FDA’s expectations when ROs review and submit their recommendations:

  1. Determine device eligibility
    • A 3P510k RO should determine whether they have the expertise to review the device type and whether that device type is eligible for 3P510k review.
    • If the RO lacks the expertise or the device is not eligible for review, the RO should not accept the 510(k) submission for review from the 510(k) Submitter. If the device is determined to be ineligible after the RO has already accepted the submission, the RO should inform the Submitter immediately and discontinue the review.
    • A 3PEUA RO should also review an EUA request to ensure that it is appropriate for 3PEUA review regardless of whether the EUA request is sent from the FDA or directly from the EUA Submitter.
  2. Assign a Product Specialist(s), Final Reviewer, and Technical Expert(s) to conduct the substantive review of a submission
    • Each submission should be assigned to a Product Specialist with appropriate expertise for the type of device under review.
    • The Product Specialist may add qualified Technical Experts to the review team and should document the rationale for choosing to use any Technical Experts to ensure sufficient competency in the review.
    • ROs should also identify at least one Final Reviewer within its organization who is independent from prior review of the submission and is responsible for providing a final supervisory assessment of the Product Specialist’s work before it is submitted to FDA.
  3. Obtain relevant FDA guidance(s) and information
    • Third Party Review Organizations should be familiar with publicly available information relevant to their review such as the FDA’s guidance database to find relevant final guidance documents, special regulatory requirements for certain class II devices, or the FDA’s Emergency Preparedness and Response website may provide additional information for 3PEUA ROs.
    • 3P510k ROs should review FDA’s postmarket databases, including recalls, market withdrawals, and safety reports, Medical Device Reports, Medical Device Reports for the device to identify any issues with clinical use of similar devices that should be considered and addressed in the review of the subject device.
    • 3P510k ROs should review a device’s product code or publicly available premarket review information in the FDA’s 510(k) database for information about the legally marketed device to which a Submitter is comparing its device, or other similar devices including Indications for Use Statements, 510(k) Summaries, Decision Summaries, and FDA decision letters.
    • Submitters should fully inform Third Party Review Organizations of any prior communications with the FDA about a device under review, including but not limited to FDA feedback obtained through the Q-Submission program, Pre-EUAs, unsuccessful marketing applications, and other interactions.
  4. Early Interaction (EI) with FDA
    • 3P510k ROs should interact, as needed, with FDA staff prior to and during the review of submissions to help ensure timely and consistent 510(k) reviews by assisting in device eligibility determinations and identifying relevant issues and contemporary review criteria.
    • The FDA encourages EIs for all 3P510k submissions especially for the first review of any device type by a Product Specialist and for any subset of device type they have not recently reviewed. In their initial recognition applications, 3P510k ROs commit to EIs with the FDA before reviewing a device type they have not previously reviewed. This interaction ensures that the 3P510k RO has the latest FDA thinking on relevant guidance, standards, and other considerations for that device type.
    • During the early interaction process with the FDA, ROs should identify one or two key questions that come up during their 510(k) review. The FDA will then triage these questions and respond to the RO. Focused key questions include asking FDA to clarify a particular issue for the 3P510k RO, such as whether the software in a device should include basic or if FDA would expect the device to be regulated under a different product code.
  5. Ensure a submission is administratively complete
    • 3P510k ROs should conduct a review of the 510(k) submission based on 510(k) regulations from 21 CFR part 807 subpart E to ensure that a submission is administratively complete and to assess whether the 510(k) submission includes all the information necessary to conduct a substantive review and to reach a recommendation.
    • The 510(k) Submitter should utilize the electronic Submission Template and Resource (eSTAR) to facilitate the preparation of 510(k) submissions to make sure a submission is administratively complete.
    • 3PEUA ROs should also ensure that an EUA request has enough information to enable review before conducting a substantive review. The exact type and amount of data needed to support an EUA may vary depending on the nature of the declared emergency or threat of emergency and the nature of the candidate product.
    • Third Party Review Organizations should not act as a consultant for the Submitter. It is the responsibility of the submitter to be familiar with the content and format requirements of a 510(k) submission or EUA request prior to submitting to FDA or a Third Party Review Organization.
  6. Conduct the substantive review of a submission
    • A substantive review for 510(k)s focuses on the evaluation of substantial equivalence (SE) as defined in section 513(i) of the FD&C Act. CFR 807.100(b) sets forth the criteria that FDA uses to determine whether a device is substantially equivalent to a legally marketed device.
    • The 3PEUA RO review and recommendation should include those materials appropriate to the conditions of authorization discussed in Appendix A of the “Emergency Use Authorization of Medical Products and Related Authorities” guidance. The review and recommendation should also include a proposed indication for use. For example, an in vitro diagnostic product indication would include the sample type, the disease or condition being tested, when the test should be administered and by whom it can be used.
    • The Final Reviewer is responsible for providing a final supervisory assessment of the Product Specialist’s work before it is submitted to FDA.
    • Lastly, when the substantive review is complete, the Product Specialist(s), Technical Expert(s) (if applicable), and Final Reviewer should reach an agreement on a final recommendation before submitting the recommendation to FDA.
  7. Identify deficiencies in a submission
    • If a Third Party Review Organization identifies any deficiencies during their review, it should contact the submitter and may use any form of communication (e.g., telephone, email, or letter) to resolve the matter provided confidentiality is maintained and the interaction is documented. ROs should avoid the exchange of substantive data and information solely over the telephone to avoid errors that may arise in the absence of a written request and response.
    • When requesting additional information from a 510(k) Submitter, 3P510k ROs should structure their additional information requests as described in FDA’s guidance document entitled “Developing and Responding to Deficiencies in Accordance with Least Burdensome Provisions” which contains examples of well-constructed deficiencies and responses to FDA’s requests.
    • ROs should document the deficiencies, the Submitter’s response to the deficiencies, and the discussion on the adequacy of the response in their review memorandum sent to the FDA along with a copy of all written communications related to resolving the deficiencies between the submitter and the Third Party Review Organization (e.g., email, letters, summary of teleconferences).
  8. Document a review
    • ROs should prepare their review documentation specifying the reasoning and steps that led to their final recommendation. 21 CFR 10.70 (“Documentation of significant decisions in administrative file”) provides a framework that should be utilized by Third Party Review Organizations.
    • The review memo should provide a clear narrative of: (1) how the device works; (2) for a 510(k), what information the submitter provided to demonstrate the device is SE to a legally marketed device, or, for an EUA request, based on the totality of the scientific evidence available, the information the submitter provided to demonstrate it is reasonable to believe that the product may be effective for the specified use, as well as recommendations pertaining to the scope of authorization under section 564(d) of the FD&C Act and conditions of authorization under section 564(e) of the FD&C Act; and (3) how the Third Party Review Organization evaluated that information.
    • The review memo should also convey how a Third Party Review Organization made their recommendation regarding the device by describing the adequacy of each section of the submission. It should also reference sections and page numbers of the submission in their review memorandum where possible.
  9. Organize and submit a submission including associated Third Party Review Organization review documentation
    • Upon completing the review of a submission, the Third Party Review Organization should submit the following to FDA: (a) the submission generated by the submitter, and (b) the review documentation generated by the Third Party Review Organization via the electronic submission template, eSTAR, which is the only currently available electronic submission template to facilitate the preparation of 510(k) electronic submissions.
    • For 3PEUA submissions, the 3PEUA RO should submit files to the CDRH Portal or CDRH’s Document Control Center. If the EUA Submitter has amended their original submission during the 3PEUA review, or the submission was sent directly to the 3PEUA RO, the 3PEUA RO should submit two separate sets of files instead.
    • The FDA recommends that 3P510k and 3PEUA ROs include the following documentation with their submission:
      • A cover letter signed by the Final Reviewer that identifies the purpose of the submission, contact information of the Final Reviewer and Submitter, the name of the device, the RO’s recommendation with respect to the device, and the date when the submission was ready for substantive review.
      • A signed certification that the reported information accurately reflects the data reviewed and that no material fact has been omitted.The Submitter’s complete submission prepared by the Submitter, not the Third Party Review Organization.
      • A review memorandum including complete documentation of the Third Party Review Organization’s review of the submission as described above and signed by all personnel who conducted the review (generally the Product Specialist(s), Technical Expert(s), when applicable, and Final Reviewer), with a decision recommendation.
    • The FDA recommends that only 3P510k ROs include the following documentation with their submission:
      • A review of the 510(k) submission contents that show the submission was administratively complete and includes all of the information necessary for the 3P510k RO to conduct a substantive review on FDA’s behalf.
    • The FDA recommends that only 3PEUA ROs include the following documentation with their submission:
      • A review of the EUA request contents to show that the EUA request includes all of the information necessary for the 3PEUA RO to conduct a substantive review on FDA’s behalf.
    • For submissions submitted directly to Third Party Review Organizations, the Submitter should sign a letter authorizing the 3P510k RO to submit the 510(k) to FDA and authorizing the 3P510k RO to discuss the contents of the 510(k) with FDA on their behalf.
  10. Submit additional information upon FDA’s request
    • After submission, if the FDA determines that additional information is needed to make a final decision (i.e., an SE determination or authorization), the agency will contact the Third Party Review Organization either by telephone or email. If the FDA requests additional information, the RO should:

3. Requirements and considerations for recognition and rerecognition of 3P510k ROs under the 3P510k Review Program

    1. Operational considerations
      • The FDA recommends that all submissions, communications, and documentation related to a 510(k) or EUA review be in English. 
    2. Management of impartiality
      • The FDA will consider whether a potential RO has established, documented, and executed policies and procedures to prevent any individual or organizational conflict of interest or the appearance of a conflict of interest, including conflicts of interests pertaining to their external Technical Experts.
      • The FDA recommends that ROs should address the following to prevent a conflict of interest:
        • Third Party Review Organizations, including their personnel, should not participate in the preparation of submissions.
        • Third Party Review Organizations should not task an individual, whether employee or contractor, with reviewing a submission, if that individual was employed within the last twelve months by that submitter or by a firm who helped prepare that submission. Personnel should not review a medical device that they developed, helped develop, or prepared for submission.
        • Third Party Review Organizations should not promise or advertise any guarantees for FDA clearance or authorization.
      • The conflict of interest policies for an RO should be fully implemented and there should be an attestation that those policies have been implemented that is signed by the most responsible individual at the organization before any submission is accepted for review.
    3. Personnel involved in reviewing activities
      • Third Party Review Organizations and their personnel should demonstrate knowledge and experience with the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act; and regulations in the Code of Federal Regulations, particularly 21 CFR Chapter I Subchapter H.
      • The FDA also recommends that ROs should maintain records on relevant education, training, and skills of all personnel; establish policies to ensure all submissions are reviewed by qualified personnel; and identify at least one individual who is responsible for providing supervision over reviews and who has sufficient authority and competence to assess the quality and acceptability of these reviews.ROs are expected to consult national and/or international standards recognized by FDA as well as FDA guidance documents and should have the capability to access FDA electronic data systems and websites to search for relevant guidance documents, recognized standards, predicate summaries where appropriate, and publicly available information regarding adverse events and recalls when performing review of similar devices.
      • 3P510k ROs must certify in their application that designated personnel will attend FDA’s training for recognition and rerecognition and are expected to complete training before conducting any 510(k) reviews under the program. FDA will not accept reviews and recommendations of 510(k) submissions from ROs that have failed to have at least one designated person attend an FDA training session for recognition. The FDA expects RO personnel to be appropriately trained.
    4. Use of external Technical Experts
      • The FDA recommends the following for Third Party ROs that use external Technical Experts:
        • ROs should ensure that external Technical Experts meet the same standards as those who work within their organization, such as freedom from conflicts of interest.
        • ROs should ensure that external Technical Experts are discouraged from subcontracting parts of their contract to subcontractors, and if they do so, then the external Technical Expert should ensure that the subcontractor meets all requirements applicable to the external Technical Expert.
        • ROs should maintain records of the qualifications of external Technical Experts, in addition to evidence of regular monitoring of the Contains Nonbinding Recommendations 31 established competence, conflicts of interest and the degree of fulfillment of the outsourced work.
        • There should also be at least one qualified Product Specialist per device type that the RO is recognized to review to ensure that there is not excessive reliance on external expertise by a 3P510k RO and to enable appropriate oversight of the qualifications of external Technical Experts by 3P510k ROs.
    5. Confidential information
      • A Third Party Review Organization is required to treat information received in submissions and contained in records, reports, and recommendations as proprietary information and may not publicly disclose confidential commercial information or any trade secret.
    6. Complaints regarding Submitters
      • If a 3P510k receives any information or complaint about a Submitter that can pose a risk to the safety or effectiveness of a medical device or public health risk, they should send an email to the FDA at 3P510K@fda.hhs.gov. A 3PEUA RO should send their complaint about an EUA Submitter to the contact provided in its contract with FDA.
    7. Third Party Review Organization recordkeeping
      • According to section 704(f) of the FD&C Act, a 3P510k RO must maintain records that support its initial and continuing qualifications to receive FDA recognition including: documentation of the training and qualifications of the RO and its personnel; the procedures used by the RO for handling confidential information; the compensation arrangements made by the RO; and the procedures used by the RO to identify and avoid conflicts of interest. 3PEUA ROs would maintain records as described in the contract between FDA and the 3PEUA RO, as applicable.
      • The FDA recommends that Third Party Review Organizations retain copies of all submission reviews and associated correspondence, information on the identity and qualifications of all personnel who contributed to the technical review of each submission, and other relevant records for at least three years a submission for review to FDA. Within 15 days of receipt of a written request from the FDA, 3P510k ROs must make copies of the requested records available at the place the FDA designates.
      • The FDA recommends that 3P510k ROs establish a recordkeeping system for tracking the submission of those complaints and how those complaints were resolved or attempted to be resolved. FDA recommends that 3PEUA ROs maintain similar records.

    4. Content and format of a 3P510k RO’s application for initial recognition and rerecognition

    • The FDA recommends that 3P510k ROs include the following in their recognition application:
      • Initial Recognition
        • In their application, potential ROs should include administrative information (i.e., mailing address, description of RO type, list of devices to review), prevention of conflicts of interest, personnel qualifications, and certification statements.
      • Rerecognition
        • For rerecognition, FDA may also consider the past premarket review performance of an RO and any information about the status of the 3P510k RO’s recognition, including information from an audit.
      • Recognition or Rerecognition Denial
        • A 3P510k RO that wishes to request a reconsideration of a recognition denial or rerecognition denial should appeal under 21 CFR 10.75 as a request for supervisory review following the appeals process outlined in FDA’s guidance entitled “Center for Devices and Radiological Health Appeals Processes.

    5. Process for suspension or withdrawal of recognition for 3P510k ROs

    • Under Section 523(b)(2)(B) of the FD&C Act, the FDA is authorized to withdraw recognition of any 3P510k or 3PEUA RO if they are not in compliance with the requirements of section 523 or poses a threat to public health. The following actions are prohibited:
      • Submission of a report or recommendation that is false or misleading in any material respect;
      • Disclosure of confidential information or any trade secrets without the express written consent of the person who submitted such information or secrets to the 3P510k RO; andReceipt of a bribe in any form or doing any corrupt act associated with a responsibility delegated to the 3P510k RO under the FD&C Act.
      • The FDA will periodically evaluate completed premarket reviews of 510(k)s and authorized EUAs submitted to FDA and perform an assessment of each RO to ensure they continue to meet the standards of recognition.

    6. Leveraging the International Medical Device Regulators Forum’s (IMDRF’s) requirements for Regulatory Reviewers under the Good Regulatory Review Practices (GRRP), as appropriate.

    • The International Medical Device Regulators Forum’s (IMDRF) is a voluntary group of medical device regulators who build on the work of the Global Harmonization Task Force on Medical Devices to s to accelerate international medical device regulatory convergence. The IMDRF Good Regulatory Review Practices (GRRP) working groups develop documents that are aligned with FDA requirements for third party review that can be applicable to submissions such as 510(k) submissions and EUA requests by providing criteria for reviewer competence, training, and conduct.
    • The FDA believes Third Party Review Organizations can leverage existing GRRP documents since they are likely to be in alignment with most FDA 3P510k and 3PEUA requirements and recommendations.

        Conclusion

        Crowell Health Solutions is prepared to assist with questions regarding the Final Rule and Third Party Review, including compliance planning and monitoring for additional developments at FDA. Please reach out with any questions. To learn more about recent federal proposed and final rules published by the FDA or other agencies, visit our blog or contact the professionals listed below.


        [1] An “unapproved product” refers to a product that is not approved, licensed, or cleared under section 505, 510(k), 513 or 515 of the FD&C Act.

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        Jason Johnson is a partner in Crowell’s Health Care and Privacy & Cybersecurity Groups, where he draws on his experience as a former research scientist to advise clients on complex compliance, legal, regulatory, and transactional matters. He helps clients in the health care and life sciences industries navigate data privacy and cybersecurity issues under U.S. and European law. He also offers strategic insights to assist clients with product development, marketing, clinical research, and other core business initiatives.

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