Third party review of 510(k) submissions – When it makes sense and which third party to choose?
What is a Third Party Review?
A third-party review is the review of a 510(k) that has been submitted directly to a third party rather than the FDA themselves. Back in 1997, as part of the FDA Modernization Act or FDAMA, the ‘Accredited Persons Program’ was created. This allowed the FDA to accredit persons, or ‘third parties’ to conduct the primary review of certain 510(k) submissions. One of the goals of this program was to be able to make the submission and review process faster and more efficient.
The third-party review is not a full alternative to submitting a 510(k) to the FDA. Third parties are authorized by the FDA to conduct the primary review of specific types of devices only. Only certain devices are eligible for third party review. The FDA keeps a database of those devices here in one of their medical devices databases (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm).
The use of a third party review also does not bypass the FDA. The third party is only conducting the primary review of the 510(k) and then forwarding the submission, the review of the submission, and the post review recommendation to the FDA. The FDA then has a 30-day timeline to issue a final determination of the submission.
How many 510(k) submissions use a third-party review?
In 2016, I did an analysis of 510(k) submissions reviewed by the general and plastic surgery panel. I reviewed submissions that received clearance between January 1, 2015, and August 10, 2016. Of the 690 510(k) clearances that were issued by the panel, only nine (9) were submitted for third party review. Although third party reviewers were responsible for only 1.3% of the submissions I reviewed, there are other device classifications with higher percentages of reviews being conducted by third-party reviewers. There were a total of 114 submissions that were issued 510(k) clearance through a third-party review process during that period.
For this article, I reviewed the 3,023 510(k) clearances that were issued in the past 12 months (i.e., May 23, 2016, through May 23, 2017). Only 75 of the 510(k) submissions issued (2.5%) were submitted for third party review. Of these 75 submissions, the average review time by the FDA (after the third party review is completed) was 46 days. Since the average review time for the FDA of a traditional 510(k) is 183 days (based upon my data analysis from 2016), third party review can potentially reduce your 510(k) clearance timeline by months.
Why do only 2.5% of 510(k) submitters utilize a third-party review?
Originally, my theory was that only a limited number of product classification codes are eligible for third party review. The FDA is trying to expand the third-party review program, but 44% of third party reviews are for the radiology panel. Another 13% were for the general hospital panel, and 13% more of the reviews were for the cardiovascular panel. Finally, less than 7% were reviewed for the dental panel. The remaining 17 submissions were reviewed for other panels. A closer look at the product classification codes shows that there are only a few product codes within these panels that are being reviewed by third parties.
I also had a second theory for why so few submitters are using third parties. As I reviewed the actual 510(k) summaries for these 75 submissions, I noticed there were only four (4) companies listed as third party reviewers in the last 12 months:
- Regulatory Technology Services, LLC (http://www.markjob.com/) = 56 submissions
- Third Party Review Group, LLC (http://www.fdathirdpartyreview.com/) = 15 submissions
- TUV SUD America, Inc. (http://www.tuv-sud-america.com) = 3 submissions
- Center for Measurement Standards of Industrial in Taiwan = 1 submission
2018 Updated- FDA’s reporting of the first three quarters of 2018
Compared with the above information, the first three-quarter reportings for 2018 list a total of more third party reviewers. Currently, in the quarterly reports from the FDA, there are the following 3rd party reviewers:
- AABB = 5 or less
- Center for Measurement Standards of Industrial (CMSI) = five or less
- New York State Department of Health (NYSDOH) = five or less
- Nordic Institute of Dental Materials (NIOM) = five or less
- Regulatory Technology Services, LLC. (RTS) = 36
- Third Party Review Group, LLC. (TPRG) = 13
- TUV SUD America, INC. (TUV) = 5 or less
The FDA keeps an up to list of approved third-party reviewers under the Medical Devices Databases. Titled Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997- (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfthirdparty/Accredit.CFM?party_key=8).
As of Quarter Three, there have been a total of 53 Third Party 510(k) Submissions Accepted. A majority of these completed by Regulatory Technology Services, LLC, and Third Party Review Group, LLC (TPRG). 36, and 13, respectively. All of the others have five or less, but these numbers may increase once the fourth-quarter report is released.
When should you choose a third-party review instead of submitting directly to the FDA?
Always check the 510(k) database to see if third party reviewers were used for your product’s classification code. Ideally, a third-party reviewer has been involved in a device that is in the same product classification, and possibly that device would be a suitable predicate for you to select for your 510(k) submission. If your search yields no results, your device may not be eligible for a third party review. However, you can always contact one of the four third party reviewers listed above.
In general, the third-party review process is an excellent way to shorten your 510(k) clearance timeline by months. The cost is significantly more than the FDA user fee. However, a faster time to market is almost always worth the increased fee. Therefore, if a third party review is available, I recommend taking advantage of this option.
Do you need help?
Medical Device Academy offers a regulatory pathway analysis service for $1,500. For those of you that are only interested in the US market, rather than including the EU and Canada, the cost for this service is only $750. Do you need help identifying the product classification for your device, determining the required performance testing, and selecting a predicate device? We can do this for you in one week or less. Do you need an expedited review? We can also determine if your product is eligible for third party review and obtain a quote for you.
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Interesting article about third-party review