The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to the Third Party (3P510k) Review Program allowing recognized third parties to perform the review of premarket notification submissions filed by medical device manufacturers.
FDA Accredited Persons Program
According to the FDA guidance, the Accredited Person (AP) Program (the formal name of the Third Party Review Program), the authority recognizes independent third party entities to review 510(k) submissions and advise the applicants regarding the proper classification of the devices subject to review in case of any doubts. In particular, FDA-recognized third parties would be allowed to review the submissions related to low-to-moderate risk medical devices.
The document provides the criteria used by the authority to identify whether the device could be subject to review in accordance with the aforementioned pathway, describes the procedure established by the agency to recognize and suspend the recognition of the third parties eligible to review the applications (3P510k Review Organizations), and also outlines the supervisions in the form of re-review performed by the authority itself.
Actually, the 3P510k review program implementation process has started far from now and could be divided into certain milestones, namely:
- 1996 – the initial launch of a voluntary pilot program for Class I and some of Class II medical devices,
- 1997 – the 3P510k program has been implemented by the Food and Drug Administration Modernization Act (FDAMA),
- 2012 – the program has been further improved by the Food and Drug Administration Safety and Innovation Act (FDASIA),
- 2017 – the detailed requirements have been developed by the FDA.
The program is intended to reduce the regulatory burden, allowing the authority to focus its activity on the most important aspects, such as scientific research or reviewing the premarket notification submissions for the devices associated with higher risk. At the same time, this would also allow reducing the time necessary to review the submission, which would result in acceleration of the regulatory process in general, providing medical device manufacturers with the possibility to place their products on the market faster.
3P510k Submission Review Process
Before commencing the review procedure, the 3P510k Review Organization should evaluate whether the device falls within the scope of its designation (recognition) using the information from the product code classification database. In case if the 3P510k Review Organization identifies the ineligibility after commencing the review procedure, it is obliged to notify the applicant to suspend the process. At the same time, if the authority would identify the fact of reviewing the submission that is ineligible for the particular 3P510k Review Organization and falls outside the scope of its recognition, it is allowed to require such third party to suspend the reviewal process and provide the authority with additional clarifications and explanations.
According to the guidance, the whole process under the 3P510k review pathway includes the following steps:
- Review of the submission by one of the 3P510k Review Organizations,
- Submission of the recommendations issued by the 3P510k Review Organization to the authority, together with the appropriate documentation accompanying the submission,
- Review of the recommendations by the authority, that is entitled to make a final decision,
- Notification of the 3P510k Review Organization about the decision taken by the FDA,
- Transferring the final decision by the 3P510k Review Organization to the applicant.
Utilization of the approach in accordance with which the FDA evaluates only the materials processed by the 3P510k Review Organizations and not the initial applications allows reducing substantially the time necessary for the authority to evaluate each particular submission. As usual, the decision of the FDA would be based on the recommendations provided by the 3P510k Review Organization, but at the same time, the authority is entitled to make a final decision that should prevail in case of any discrepancies. According to the rules, the FDA shall render its final decision within 30 calendar days from the day it received the submission from the 3P510k Review Organization.
The applicant shall pay to the 3P510k Review Organization for the services it provides while any fees should not be paid directly to the FDA. During the whole process, the 3P510k Review Organization acts as an intermediary and maintains communications between the authority and the applicant.
It is also important to mention that participation in the program still remains voluntary, so the manufacturers intended to file a 510k premarket notification submission could consider it as one of the options, and not the obligatory procedure since they are allowed to use the Traditional, Special, or Abbreviated Programs instead on their sole discretion.
3P510k Medical Device Eligibility
The document provides a list of criteria used by the authority to define whether the device could be subject to review under the 3P510k pathway, such as:
- The risk associated with using the device depending on its type. To assess this issue, the authority evaluates the safety and performance of the device and its compliance with all applicable requirements using the information provided. According to the general rule, Class III medical devices could not be reviewed in the course of 3P510k program since they are considered as high-risk devices.
- The way the devices should be used, as well as its importance for patient`s health. To evaluate this aspect, the authority refers to such concepts as implantable medical devices, sustaining human life and supporting human life – in cases when they are applicable, the manufacturer would have to provide additional information confirming that utilization of the 3P510k program would be suitable.
- The novelty of the device. If the device walls within the scope of the De Novo pathway used for entirely new medical devices having no analogues already placed on the market, such a device could be determined as ineligible.
- The availability of the information about the device subject to review as well as the possibility to share it.
- The expertise needed to evaluate the device. For instance, the device could be found ineligible in case if it is necessary to review clinical data, or to consult with several organizations within the FDA structure, if the device constitutes a combination product, etc. At the same time, the authority also emphasizes that if it is sufficient to review simple clinical data to evaluate all aspects related to safety and performance and make a reasonable decision, such a device could still be eligible for the 3P510k program.
- The postmarket surveillance data on the devices of the same type – if the amount of adverse events and claims associated with the devices of this type is significant, the device could be found ineligible.
All the aforementioned aspects would be taken into consideration by the authority when determining the eligibility of the particular device subject to review to the 3P510 program. The authority also maintains the database of eligible medical devices and keeps it updated to reflect any changes in regulatory requirements.
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