THIRD-PARTY REVIEW PROGRAM
HOW TO SUBMIT:
Here are four basic steps to submit a 510(k) through the program.
- Determine if your device is eligible.
To determine if a 510(k) submission is eligible to be reviewed under the Third Party Review Program, the 510(k) submitter can do any of the following:
- Review the list of eligible devices for the device product code (most Class I and Class II devices are eligible);
- Search the FDA's Device Classification Database;
- Contact a Third Party Review Organization 3P510k (Review Organization); or
- Contact the FDA at 3P510k@fda.hhs.gov.
- Find and contact a 3P510k Review Organization that can review your 510(k).
- A 510 (k) submitter can use either of the methods below to find and contact organizations that can review their 510(k) submissions:
- Access the List of Devices for Third Party Review page and then:
- Click on a device type at the bottom of the page. This will display a table with regulation names and product codes; and
- Click on the product code of the device. This will display additional information for the product code, including a list of any 3P510k Review Organizations that are eligible to review that type of device.
- Review the list of 3P510k Review Organizations (also referred to as Accredited Persons). The list of 3P510k Review Organizations shows the devices each organization is accredited to review and their contact information.
- Access the List of Devices for Third Party Review page and then:
- Obtain price quotes from one or more 3P510k Review Organizations and make a contract for a review.
The fee for a review is determined by the agreement between the 510(k) submitter and the Review Organization. The 510(k) submitter pays the fee directly to the 3P510k Review Organization. The FDA does not collect a user fee for third party submissions.
- submit the 510(k) to the 510k Submission Review Organization
- A letter authorizing the 3P510k Review Organization to discuss the 510(k) with the FDA and to forward it to the FDA on the 510(k) submitter's behalf. The letter should include:
- Name of the 3P510k Review Organization.
- Name and contact information of the person assigned to the review; and
- Device trade name.
- The complete 510(k) submission, including the supporting data, summaries and analysis in the format requested by the 3P510k Review Organization.
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- A letter authorizing the 3P510k Review Organization to discuss the 510(k) with the FDA and to forward it to the FDA on the 510(k) submitter's behalf. The letter should include:
- Name of the 3P510k Review Organization.
- Name and contact information of the person assigned to the review; and
- Device trade name.
- The complete 510(k) submission, including the supporting data, summaries and analysis in the format requested by the 3P510k Review Organization.
- A letter authorizing the 3P510k Review Organization to discuss the 510(k) with the FDA and to forward it to the FDA on the 510(k) submitter's behalf. The letter should include:
HOW TO BECOME AN THIRD-PARTY ORGANISATION:
Content of Application
- 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
- Name and title of the most responsible individual at the 3P510k Review Organization
- Brief description of the 3P510k Review 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.
- Prevention of Conflict of Interest
- Personnel Qualifications
- Certification Statements
SUBMIT THE APPLICATION
Once the documentation has been turned into one PDF document, the applicant can submit it to:
3P510k@fda.hhs.gov;
Attention: CDRH Third Party Premarket Review Program
Training, Guidance, and Other Resources for Third-Party Review Organizations
Third Party Review Organizations (3P510k Review Organizations) are responsible for preparing a review memorandum documenting the reasoning and steps that led to a Substantially Equivalent or Not Substantially Equivalent recommendation.
- Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews
- Under this plan, FDA is setting a goal that by the end of FY 2021 at least 85% of 3P submissions will not require substantive re-review by FDA. FDA will achieve this objective by taking the following new, additional actions:
- Ensuring the device types eligible for the 3P Review Program is appropriate.
- Giving 3PRO reviewers the tools they need to succeed. Providing a way for 3PROs to demonstrate that they can successfully apply FDA’s criteria for reviewing a 510(k) submission.
- Implementing a comprehensive framework for FDA processing of 3PRO 510(k) submission packages.
- Using program measures to monitor the 3P Review Program, adjusting as necessary to ensure goals are met, and using continuous process improvement activities to identify and implement improvements where appropriate.
Giving Third-Party Reviewers the Tools They Need to Succeed
FDA will...
- Deliver web-based training and resources to 3PRO reviewers
- Provide a review template to 3PRO reviewers to help guide their review and ensure their review contains all required information
- Make it easier for3PRO reviewers to ask questions to FDA and receive swift responses during their review
- Establish an Updates Channel so 3PRO can stay current as technology evolves and
General Training Resources
FDA will...
- Identify gaps in current publicly available training and internal FDA reviewer training
- Enhance available web-based training accordingly
- Inform 3PROs of new material through the Update Channel
3P Program Measures
To provide a comprehensive view of 3P Review Program efficiency, the 3P Review Program has defined measures that cover the entire 3P Review lifecycle.
As illustrated in the Third-Party Review Organization Report, FY18, Q2, the lifecycle has four Stages:
Stage A: The Third Party receives a file from 510(k) Submitter.
Stage B: FDA receives submission and decision recommendation from Third Party
Stage C (Optional): As needed, FDA requests additional information and puts the submission on hold until it receives a complete response to the request.
Stage D: FDA reviews all needed information and makes a final decision.
Conclusion
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- Remove the types of devices that consistently require FDA re-review from the 3P process
- Provide 3P reviewers the tools they need to succeed, including expanded general training opportunities, expanded device-specific training, the provision of tailored review memo templates, an updated Early Interaction Process, and an Updates Channel.
- Enhance the Recognition process to give 3PROs the opportunity to demonstrate their capability to perform FDA-equivalent reviews, including the creation of standards for recognizing, re-recognizing, auditing, and suspending 3PROs.
- Establish a Framework to help FDA reviewers determine whether a re-review is necessary.
- Use publicly available metrics to monitor individual 3PRO performance and the performance of the 3P Review Program as a whole; periodically perform continual improvement analyses to identify possible areas for improvement and adjust the program accordingly, as necessary.
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