The FDA wants to harmonize the agency’s 510(k) third party review submission process with those of other countries participating in the International Medical Device Regulators Forum (IMDRF).
Harmonizing FDA’s 510(k) Third-Party Review Process With the World
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On September 12, 2016, the agency issued the “510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.” Click here to read the entire 34-page document.
The third party review program authorizes FDA to accredit third parties to review premarket notification 510(k) submissions and recommend the initial classification of certain devices. This includes establishing a process of recognition of qualified third parties to conduct the initial review of 510(k)s for certain low-to moderate-risk devices eligible under the review program.
The guidance encourages device makers to participate in the IMDRF’s Single Audit Program’s (MDSAP) Regulatory Authority Council, which is expected to begin full implementation on January 1, 2017.
MDSAP allows device makers to contract with an authorized Auditing Organization (AO) to conduct a single audit to meet the regulatory requirements of all fully participating regulatory authorities, which includes Australia’s Therapeutic Goods Administration (TGA), Brazil’s National Health Surveillance Agency (ANVlSA), Japan’s Ministry of Health, Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), and Health Canada.
The guidance outlines the content and format of an application for initial recognition and re-recognition as a third-party review organization, as well as the requirements and recommendations for such a designation as such an organization.
The new draft replaces draft guidance from February 2013, entitled “Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers.”
You’ve got 120 days to submit your electronic comments on the draft guidance. Go to: http://www.regulations.gov.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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