US Regulators Plan Overhaul of Third-Party 510(k) Review Program
Regulatory Updates |
EMERGO SUMMARY OF KEY POINTS:
- US FDA is amending its 510(k) third-party review program 3PRO to reduce the need for agency re-reviews of these submissions and market entry delays.
- As part of the 3PRO overhaul, FDA will adjust its list of eligible devices to focus more on lower-risk, less complex products.
- By 2021, FDA wants 85% of 3PRO-reviewed 510(k) submissions to go through without the need for agency re-review.
The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications that have undergone third-party review by the agency’s 2021 fiscal year.
FDA intends to achieve this goal by revamping its 510(k) Third Review Program (3PRO) as well as clarifying which types of medical devices meet the criteria for third-party 510(k) reviews via new draft guidance. According to FDA, changes to 3PRO will allow the regulator to focus on reviewing more complex and higher-risk devices while improving US market access for lower-risk products whose safety and effectiveness may be more easily assessed by third-party reviewers.
How 510(k) third-party reviews currently work
In its current form, the FDA’s third-party review (3P) program (known as the Accredited Persons or AP Program) entails the following steps:
- 510(k) applications for devices with eligible product codes submitted to the 3P;
- 3P uses FDA criteria to evaluate 510(k) submissions;
- 3P sends submissions to FDA along with Substantially Equivalent or Not Substantially Equivalent recommendations;
- FDA issues final determination based on 3P’s recommendations.
However, FDA may also deem it necessary to re-review 510(k) submissions from third-party reviewers within 30 days of receiving these submissions.
“When FDA routinely re-reviews 3P submissions, it prevents FDA and sponsors from experiencing efficiencies the 3P Review Program is meant to achieve, including that reviewers do not have more time to focus on higher-risk and more complex devices,” states the agency.
To reduce the need for re-reviewing 510(k) submissions from 3Ps, FDA plans to amend the list of device types eligible for third-party reviews so that more complex and higher-risk devices are not included; equip 3Ps with more resources and tools to provide more sound Substantial Equivalence recommendations; establish clearer criteria to help FDA reviewers determine when re-reviews of submissions from 3Ps is warranted; and installing a process to monitor and evaluate the 3P Review Program.
Revisiting device eligibility for 3P reviews
First, FDA argues that 510(k) submissions for lower-risk, simpler devices are less likely to require re-review following 3P evaluations.
Following the FDA Reauthorization Act of 2017 (FDARA), the agency now has the authority to amend its list of devices eligible for 3PRO, and plans to remove some higher-risk devices from program qualification based on new listing guidance.
More resources for 3P review organizations
Second, FDA intends to expand the pool of resources available to 3P review organizations so that these entities’ 510(k) review recommendations are deemed equivalent to agency reviewer determinations.
Additional tools and resources FDA has identified to provide to 3P reviewers include:
- Expanding general and device-specific training programs;
- Developing guided, tailored review templates for specific device types;
- Setting up an Early Interaction process wherein 3P reviewers can consult with FDA staff during premarket reviews;
- Setting up Update Channels to alert 3P reviewers when new or amended regulations affecting devices under their review are adopted.
New framework for 510(k) re-review determinations
Besides more resources for 3P review organizations, FDA also plans to provide more support to the agency’s own reviewers to evaluate 3P review recommendations and determine whether to re-reviews of these submissions.
FDA identifies several criteria its reviewers should consider when evaluating 3P review recommendations; these include a 3P review organization’s capability, device level of complexity, type of device under review, and characteristics of the manufacturer whose device is under review.
Following a performance report FDA issued in early 2018 that in some cases showed slower third-party 510(k) review timeframes than for standard FDA premarket reviews, the regulator’s moves to overhaul and bolster 3PRO to provide a more efficient US market pathway should be welcome news to qualifying manufacturers (if effectively implemented).
Learn more about US FDA 510(k) registration requirements:
- US FDA 510(k) application consulting for medical devices and IVDs
- FDA medical device and IVD regulatory strategy
- Whitepaper: Preparing a US FDA 510(k) submission
- Whitepaper: Determining Substantial Equivalence for FDA medical device registration
- Clearance calculator: How long will it take to clear my FDA 510(k) application?