The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, has recently published a transcript of the final guidance dedicated to the 510(k) Third Party Review Program (3P510K). The document follows the initial guidance on 3P510K issued by the Agency earlier in March 2020, providing medical device manufacturers and other parties involved with the additional information necessary to maintain compliance with the regulatory requirements. The FDA has also updated the list of medical devices that could be subject to review under the aforementioned regulatory framework.
FDA Guidance on 3P510K: Key Points
The present FDA guidance on 510(k) Third Party Review Program highlights the most important regulatory aspects, namely:
- The factors used by the Agency to determine whether the particular medical device in question is eligible for review to be conducted by the 3P510K Review Organizations (the entities entitled to perform assessment under the 3P510K regulatory framework),
- The process and procedures performed by the Agency in order to recognize the Review Organization to carry out the assessment, to suspend or withdraw the recognition,
- Maintaining the proper quality of the services provided by the Review Organizations.
FDA 510(k) Third Party Review Program in Brief
The 510(k) Third Party Review Program has been introduced by the Agency in order to expand the availability of medical devices and accelerate existing regulatory procedures to be carried out when placing an entirely new medical device on the market while maintaining the highest level of the patients` health protection. According to the information published by the FDA, the implementation of the 3P51K is associated with the following benefits:
- It allows the Agency to focus its attention and resources on the most complicated medical devices or ones associated with the highest risk,
- It allows to expand the availability of the low- and moderate-risk medical devices to the patients and healthcare authorities by reducing significantly the time necessary to place the device on the market – when using the 3P510K framework the new device could be placed on the market within 30 days or even faster,
- It provides medical device manufacturer with the possibility to apply for conformity assessment to the organizations duly authorized and accredited by the FDA,
- It expands the accessibility of the FDA-equivalent reviews for the low- and moderate-risk medical devices, improving the productivity of the Agency.
Thus, the 510(k) Third Party Review Program is a voluntary alternative to the general medical device registration process set forth by the basic 510(k) regulatory framework the medical device manufacturer may apply for in case if the device in question is eligible for the 3P510K.
The whole process includes the following steps:
- The manufacturer of the device decides on the appropriate Third Party Review Organization to carry out the review,
- The manufacturer submits the appropriate application to the Review Organization,
- The Review Organization performs a rigorous assessment of the documents provided and submits its recommendations concerning the device in question to the Agency,
- The Agency performs a supervisory-level review and makes a final decision. Under certain conditions, the Agency is also allowed to return the application requiring the Review Organization to perform the additional assessment.
At the same time, it is also important to mention that all parties to the process could communicate with each other, while the Review Organization performs a key role in ensuring efficient communication between the manufacturer of the device and the Agency. For example, the manufacturer may ask questions of the Agency, or all parties could arrange a three-way call to discuss the most important aspects related to the submission.
Medical Device 3P510K Eligibility Criteria
As it is stated in the guidance, the actual effectiveness of the Program depends significantly on the devices subject to review. According to the document, first of all, it is important to ensure the device in question is eligible for the 3P510K review.
The decision regarding the eligibility of the device should be based on the following criteria:
- Associated risk. In order to be eligible, the device should be a low-risk medical device, providing that multi-faceted or interdisciplinary expertise is not required to perform the conformity assessment,
- Complexity. The device should be well-understood, providing that the information the Review Organization would need to assess the device is publicly available,
- Post-marketing surveillance. The device should not have post-market safety signals (thus, the 3P510K program could not be applied for the entirely new medical devices).
The Agency states that half of all 510(k) applications submitted to the Center for Devices and Radiological Health (CDRH) are eligible for Third Party review.
In order to check the eligibility of the device submitted for review from its side, the Review Organization checks the product code of the device using the appropriate FDA database.
Third Party Review Organizations
As it was stated in the present FDA guidance, the entity that is going to apply for the designation as a Third Party Review Organization should submit the appropriate application until September 12, 2020.
The application should contain the following information:
- General information about the applicant, including the particular types of medical devices to be covered by the scope of recognition,
- Special procedures and internal policies implemented by the entity in order to prevent the potential conflicts of interest,
- Details about the personnel, including the information about qualification and experience,
- Certification statements.
After the recognition, the Agency provides the newly designated Third Party Review Organization with the necessary training, and also with the feedback during its operating activity. The Agency could also conduct an audit from 12 to 18 months after the recognition.
Upon receiving the 510(k) submission, the Review Organization checks the eligibility of the device and assigns the appropriate specialist having qualification and experience necessary to review the medical device of that type. Then, depending on the product code and type of the device in question, the Review Organization chooses the appropriate guidance and standards to be applied. In case of any doubts on the particular guidance to be applied, the Review Organization may consult with the Agency to make a proper determination. The completeness of the application submitted should be also checked at this step.
The review of the device itself should be focused on the changes from the predicate – the equivalent medical device already placed on the market (FDA-approved medical device). In particular, it is necessary to assess the indications for use and any and all modifications made to the device. All changes to the device should be justified and duly documented by the manufacturer. During such an assessment, the Review Organization can also require the medical device manufacturer to provide additional information regarding the device in question and assess whether the additional clarification provided is sufficient.
Summarizing the information provided in the FDA guidance on the 3P510K Review Program, the new framework allows to accelerate the process to be performed to place the device on the market while allowing the Agency to focus its scientific resources and efforts at the most complex and high-risk medical devices requiring rigorous assessment.
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