The FDA wants to establish five categories of Class III devices.
Five Class III Device Categories Proposed
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After complaints from stakeholders that the original deadline of June 23, 2014 did not allow for enough time to analyze and respond to the proposal, the agency backed down and extended the deadline to comment on the proposed rule on classification and reclassification until September 22, 2014.
Then There Were Five
The five categories of Class III devices would be defined by risks, benefits and available controls. According to the agency, moving to the new classifications could streamline classification of high-risk devices and promote consistent expectations about the process and provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.
Under the planned rule, Class III devices would fall into one of the following categories:
- Devices that present known risks that can’t be controlled;
- Novel devices for which the risk-benefit profile is unknown or unfavorable;
- Devices for which general and special controls are insufficient, necessitating a full review of manufacturing information;
- Devices for which premarket review of any change affecting safety or effectiveness is required; and
- Combination products.
The FDA currently categorizes medical devices into one of three classes—Class I, II, or III—based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk.
Recent changes to the FDA law allow for the reclassification of devices by administrative order instead of by regulation.
Read It Here
Interested parties may submit electronic comments to http://www.regulations.gov or written comments to Docket No. FDA-2013-N-1529. Read Thursday’s Federal Register notice here. The proposed rule is here: http://www.fdanews.com/ext/resources/files/03/03-31-14-Classification.pdf.
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Discussion
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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