The Many Benefits of Using the FDA Third Party Review Program

The Many Benefits of Using the FDA Third Party Review Program

Medical device consultants on another lesser known, yet beneficial FDA program

It’s time to submit another run of the mill traditional 510(k) for your medical device = same old fee, same old timeframe. You are just going to submit your 510(k) to the FDA per usual and wait 90 days for feedback, or hopefully that 510(k) clearance letter. Why? Because that’s “what you have always done” and you know what to expect. Well, did you know you have another option called “Third Party Reviews”? Here at PDG® we are constantly reviewing regulations and keeping up with programs like these, to ensure you have access to all of the resources available.

What is the FDA Third Party Review Program?

“The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA), based on an FDA pilot.”[1]

FDA has granted accreditation to certain review companies that allow the third party to do all of the review work and submit to FDA on behalf of the client/sponsor. FDA entrusts the third party reviewer has already reviewed the 510(k) for all parts and requirements and worked with the sponsor to tighten up their submission. FDA then has 30 days to review and decide if the 510(k) is cleared to market. Thus, in effect the sponsor should have a quicker review/response time, than if they merely followed their usual process of submitting and waiting… and waiting… and waiting… to only find out they need additional information.[2]

Refer to the marketing chart below from an accredited third party reviewer[3] that shows their average timeline difference compared to the average of a typical standard submission.

Table 1: Review Cycle Timeline Comparison[4]

2015 Standard Review Cycles
FDA
172 Day Average
TPRG
65 Day Average
DAY 1
FDA receives submission.
DAY 1
TPRG confirms receipt of 510(k) submission, validates eCopy compliance, formatting and pagination.
DAY 7
FDA sends Acknowledgment letter or sends Hold Letter if unresolved issues with User Fee and/or eCopy.
DAY 2-10
Administrative Review: TPRG assigns Primary and Senior reviewer and completes RTA checklist. Applicants immediately notified of deficiencies. Estimated timeline + 10 days.
DAY 15
FDA conducts Acceptance Review. Informs submitter if 510(k) is accepted for Substantive Review or placed on RTA Hold.
DAY 10-30
Substantive Review: TPRG interactive review allowing open lines of communication. Performs scientific assessment, formally documents the review and finalizes recommendation to FDA. Estimated timeline + 20 days.
DAY 60
FDA conducts Substantive Review. Communicates via Substantive Interaction to inform the submitter that they will proceed with the Interactive Review of the submission or it will be placed on hold and additional information is required.
DAY 31-65
FDA Review Phase: TPRG forwards the submission to FDA, obtains K number and manages all FDA communication for the applicant. FDA has 30 calendar days to complete SE determination. Estimated timeline + 30 days.
DAY 90
FDA sends final MDUFA decision on 510(k).
DAY 100
If MDUFA decision is not reached by Day 100, FDA provides communication that identifies outstanding review issues.

What are the bottom line benefits of using a third party review?

Benefit to applicant:

With quicker time-to-market, it garners the applicant the opportunity to make money…sooner! One accredited third party reviewer claims, “The program allows clients to fast track their 510k submissions reducing time to market by 100 days on average.”[5] It may cost a little more at the onset, but you can do the math to determine what this might mean to your company in the long run. Under a traditional 510(k) submission, the applicant may only request information from the FDA on the status of their 510(k) review 90 days after its initial date of submission to the FDA. On the other hand, the Accredited Persons Program requires the FDA to respond to third-party reviewed files within 30 days.[6]

Benefit to FDA:

The program is also beneficial to the FDA. As they acknowledge, 510(k)s are “the process by which most medical devices receive marketing clearance in the United States.”[7]

This not only allows FDA to have assistance in the abundance of reviews necessary to keep up with the demand, it also allows them to focus on higher level applications. FDA promoted in their guidance document on benefits of third party reviews that they “enable FDA to use its scientific review resources for higher-risk devices, while maintaining confidence in the review by third parties of low-to-moderate risk devices.”[8]

Benefits to the market:

The benefits to the FDA also benefit us, as consumers. Optimally, we want FDA to focus on the moderate to higher risk products and get as many products to the market, as soon as possible. In the end, allowing more options for consumers, usually brings the price of products down and more access to needed devices to consumers overall.

Expansion of the program over the years

Since the inception of the program and its success, the program has now expanded to include even more class II products in a pilot study. In February of 2002, FDA claimed “In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible.”[9]

In 2012, TUV (an accredited third party reviewer) estimated “at present, the eligible devices under the FDA 510(k) Accredited Persons Program account for more than 60% of all 510(k) submissions.”[10]

Therefore, chances are your device might be eligible for this program. Contact PDG to assist with all of your 510(k) and medical device needs. We have expert consultants that can review your medical device and its eligibility in the FDA third party review program.
Don’t delay, contact PDG today! You may just get your device to the market sooner than you thought.

Jodi Hutchins is an Independent Regulatory and Quality Consultant with over 15 years of global medical device registration experience, to include FDA 510(k) submissions. She held her most recent position for 9 years, as QA/RA Director for a Worldwide distributor of medical devices.

Charles Jaap is Vice-President of Operations and Business Development for PDG, a global pharmaceutical and medical device consultant with extensive experience in the strategic development of drug products and medical devices. Please feel free to contact us for more information.

The opinions and statements in this paper are solely those of Charles Jaap and Jodi Hutchins and do not necessarily reflect those of PDG™.

Sources:
[1] Third Party Review. What is Third Party Review? www.fda.gov. Updated 6/25/14 and accessed 6/28/16
[2] Ibid @ 1
[3] Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997. www.fda.gov. Updated 6/27/16 and accessed 6/28/16.
[4] Table adapted from TPRG Review Track. www.fdathirdpartyreview.com
[5] TPRG home page. http://www.fdathirdpartyreview.com. Accessed 6/28/16
[6] FDA Accredited Persons Third-Party 510(k) Review Program. https://www.tuv-sud.com/uploads/images/1378297477191319720189/fda-510k.pdf. Accessed 6/28/16
[7] Ibid @ 1
[8] FDA Guidance: Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. www.fda.gov. Issued 2/2/01. Accessed 6/28/16
[9] List of Devices for Third Party Review. www.fda.gov. Updated 2/7/02 and accessed 6/28/16
[10] Ibid @ 6
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