Understanding the FDA 3P510K Guidance for Third-Party Review


The time lags due to FDA resources constraints oft-associated with companies receiving a Substantially Equivalence Determination (510(k) review) to bring their products to the market has proved to be a concern. This article takes stock of the 3P510K process, and SGS involvement in the 3P510K process, with a focus on SGS’s end-to-end assessment capabilities to provide answers with maximum efficiency.

Against the backdrop of the numerous delays that have frustrated the procurement of 510(k) substantial equivalence experienced by companies looking to place their manufactured devices on the market, the FDA reeled out 3P510K (3rd Party 510(k)). The 3P510K was innovated to meet the ever-rising demand for reviewing newly manufactured medical devices and issuing equivalence determination (510(k)) through third-party organizations. Through a 510(k) application to the FDA, manufacturers signify their intention to place their products on the market, and that these products are deemed safe, effective, and substantially equivalent to another device currently in the market.

The 3P510K — An Overview

Amidst the volume of 510(k) requests from medical device manufacturers — to determine whether their manufactured medical devices are substantially equivalent (SE) or not substantially equivalent (NSE), the FDA came up with the 510(k) Third Party Review Program (3P510K) targeted at decongesting its administrative workload.

Prior to this time, the FDA initially struggled to meet high levels of demand for a period spanning at least two (2) decades. The FDA resorted to The Medical Device User Fee Amendments to recruit more human resources — this effort proved to be unsuccessful to meet the demand.

In an attempt to optimize this model, the FDA came up with a multi-year analysis that factored in previous failed attempts at an outsourced/3rd-party review program. The review produced an eclectic range of shortcomings, from incidents of double reviews (where the companies pay once and get reviewed twice, which was time-consuming) to internal feedbacks within the FDA suggesting that some Class II devices bore the potential risk of a greater magnitude, and should be afforded more scrutiny than a third-party organization.

3P510K review program aims towards yielding an upturn in 510(k) decision speed, especially as in the status quo, the process of procuring 510(k) decisions from pre-market submission was somewhat beset with bottlenecks, resource constraints and complex paper-work processes. These consume valuable time that could prove overly costly in light of the marketing considerations and projections of 510(k) submitters.

With the FDA agreeing to no second review, the 3P510K serves up an efficient option to manufacturers as accredited third-party review organizations are empowered to review low-to-moderate risk medical devices. This way, the FDA is relieved of a congested ‘review workload,’ with its attention re-focused on playing an oversight role while still retaining the necessary resources to scrutinize higher risk Class II devices and PMAs.

Now, the FDA is able to leverage its collaborations with third parties to shorten the process of getting 510(k) medical device clearance through the premarket notification.

SGS’s 3P510K Partnership

As part of its concerted efforts towards helping these companies bring their manufactured devices to the market efficiently and safely, SGS is partnering with the FDA to meet these demands. In the same token, it procured the FDA’s approval to participate in 3P510K premarket submissions for manufactured medical devices. There are some salient features of the SGS — SP510K partnership that can be reeled out:

  1. There is no incidence of double reviews by the FDA (and SGS).
  2. 510(k) submitters will still get their FDA letter-headed letter for clearance purposes.
  3. SGS engages the services of trusted, dedicated experts to review the devices.
  4. A medical device manufacturer may elect whether or not undertake this review program. (It is voluntary)
  5. It operates as a direct alternative to the traditional FDA 510(k) review.

Since the FDA is mandated to operate an ‘all-comers’ policy where it cannot omit submissions that are below the required standard, most submitters exploit the 3P510K channel to circumvent the FDA. In a bid to avoid this, SGS screens these submissions, weeding out ‘ineligible’ candidates (candidates without a good chance of securing a 510(k)) in the process to reduce the workload on the FDA.

For as long as a company wishes to pursue its 510(k) submission, SGS will commit to reviewing it. Also, when a company wishes to deal directly with the SGS, they must first withdraw their submission from any other reviews underway.

The SGS 3P510K program’s end-to-end capabilities come to light when the accepted 3P510K becomes scheduled and SGS commits to an agreed date on the calendar with the company, after which the company provides complete submission and SGS reserves a date of dedicated reviewing by its team of experts. The same applies to fixing a deliverable date, after which SGS runs optimization checks before final submission to the FDA.

SGS, however, does not guarantee a substantial equivalence determination. The metric such an evaluation would be predicated upon include but are not limited to proposed device, predicate, and the bench data accumulated to document equivalence.

In conclusion, swift execution of the reviewing and clearance of low-to-medium risk 510(k) devices is made possible with the collaborative efficiency of the FDA and SGS. This also presents an opportunity to 510(k) submitters, who are SGS customers with a more proven track record in 510(k) submissions, to navigate their manufactured medical devices into the market swiftly.

SGS Solutions

In addition to 3P510K review, SGS offers a comprehensive range of services, including auditing and product testing, to help companies gain certification. Contact us today to learn about how we can help better prepare you for your 3P510K review.

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