On Thursday, February 2, Senators Bob Casey (D-PA) and John McCain (R-AZ) introduced S. 2067, titled the “Safe, Efficient, and Transparent Medical Device Approval Act” or the “SET Device Act.” The bill would require FDA to reclassify preamendment Class III devices or require them to go through the premarket approval (“PMA”) process, and would streamline the de novo process.
In the Safe Medical Devices Act of 1990, Congress amended Section 515 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to require FDA to reclassify preamendment Class III devices to a lower class or require them to go through the PMA process. The deadline to do so was December 1, 1995, but FDA still has over 20 preamendment Class III devices to reclassify. The SET Act would require FDA to issue a final regulation for each device it determines should remain in Class III, or special controls for devices it reclassifies into Class II, within 18 months of enactment of the bill.
This would not be the first time FDA has been encouraged to comply with the statutory requirements to classify the remaining Class III preamendment devices. In January 2009, the Government Accountability Office (“GAO”) issued a report recommending that FDA “expeditiously take steps to issue regulations for class III device types currently allowed to enter the market via the 510(k) process by requiring PMAs or reclassifying them to a lower class.” In response to the GAO report, FDA stated that it was committed to complete the classifications “as expeditiously as possible.” In the three years since then, FDA has only issued final rules classifying four devices. Given FDA’s disregard for the timeframe in the current statutory requirement, and its failure to follow through after the GAO report, there is no reason to believe that FDA will comply with the 18 month deadline put forth in this proposal.
Like two bills proposed in Congress in 2011 on which we previously commented (here and here), this bill also proposes to streamline the de novo process. The current statutory language requires a sponsor to submit a 510(k) notification to FDA even if believes there is no appropriate predicate device. The sponsor must then wait to receive a not substantially equivalent determination from FDA before it submits a de novo reclassification petition to reclassify the device into Class I or II. Under the proposal in the SET Act, a sponsor may follow a process similar to that under current law, or may submit an initial petition for reclassification after determining that no predicate exists without the need to submit a 510(k) and wait for a not substantially equivalent determination.
This proposed change will benefit both industry and FDA. It will save FDA time and resources by consolidating the 510(k) review and de novo classification processes into one step. It will also allow sponsors to more quickly bring new, innovative, low- to moderate-risk devices to market because they can submit a reclassification petition without having to wait for a not substantially equivalent decision. Despite these positive procedural steps, the question remains whether FDA would be willing to review devices through the de novo process rather than requiring devices without a predicate go through the PMA process. One of the reasons FDA may be hesitant to utilize the de novo process is the burden of creating special controls. Perhaps if, in addition to remedying the procedural hurdles, creating special controls could be optional, FDA may be more likely to clear products through the de novo process. Nevertheless, this bill is a step in the right direction. As we stated in our prior blog posts on this topic, FDA and industry both would like to see improvements in the de novo process, and this bill should receive much support and little resistance.
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