|Trends & Perspectives|
FDA issued its guidance for industry and FDA staff titled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” In the guidance document’s introduction, FDA states that it proposes the “downclassification” and exemption from 510(k) requirements of the Class II devices that are the subject of the document because the safety and effectiveness of those devices is sufficiently established.
Late last year, FDA issued its guidance for industry and FDA staff titled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” In the guidance document’s introduction, FDA states that it proposes the “downclassification” and exemption from 510(k) requirements of the Class II devices that are the subject of the document because the safety and effectiveness of those devices is sufficiently established. These devices also have, according to FDA, sufficiently controlled risks that general controls are able to manage.
For the Class I devices that are the subject of the guidance document, FDA intends to propose an amendment to the classification regulations to exempt these devices from 510(k) requirements that currently apply.
While FDA proposes and finalizes these downclassifications and exemptions, it will exercise enforcement discretion with regard to 510(k) submission requirements for the relevant devices.
The devices subject to enforcement discretion per this document include the following:
• Clinical chemistry devices, such as iron (non-heme) test systems, breath-alcohol test systems, and others;
• Hematology devices, such as platelet-adhesion tests, euglobulin lysis time tests, and others;
• Immunology and microbiology devices, which include hemoglobin immunological test systems.
Background and Impact of the Guidance Document. Peper Long, associate director for external relations at CDRH, told IVD Technology in an e-mail that the IVD industry, via AdvaMed, presented the agency with a suggested list and process for determining a set of devices that, given current knowledge of those devices and the right controls, can safely be exempted from the premarket notification requirement. FDA considered this list and the process itself while performing its own analysis. “As a result,” wrote Long, “FDA identified many of the same devices industry had identified, but also several others.”
Long wrote that FDA believes that the guidance document “shows FDA’s commitment to using the least-burdensome regulatory controls that still allow for the safe and effective use of medical devices.” It also, she wrote, “shows that FDA is open to adjusting this balance for a particular device to reflect our experience and new regulatory tools and methods that become available.”
Long believes this document benefits IVD manufacturers by freeing up resources---“theirs and ours,” she wrote---for premarket review of devices that “really need that effort.”
A Drop in the Bucket? Thomas Tsakeris of Devices & Diagnostics Consulting Group (Rockville MD) believes that FDA’s intent to exercise enforcement discretion for certain IVDs reflects better focus of agency-oversight resources, but “only slightly.” He points out that the listed devices are relatively low-risk, conventional assays which he suspects “represent analytes for which 510(k)applications are not submitted with any high frequency.” Impact on the IVD industry, he believes, will be minimal, and his assessment is that the guidance is a nominal attempt by FDA to demonstrate regulatory flexibility. “However,” he says, “this flexibility is being applied in diagnostic test areas where flexibility is not significantly sought by the IVD industry.”
Tsakeris adds that while the reclassifications and exemptions described in the guidance document may not be particularly significant, what is remarkable is the method FDA is using-issuing a guidance document rather than “implementing formal and burdensome rule-making procedures.” FDA has been criticized in the past, he says, for attempting to extend its regulatory reach via guidance document rather than the making of rules, such as with the regulation of multivariate assays and LDTs. In this case, however, Tsakeris believes that reducing the regulatory burden, “even for a few low-risk IVDs,” via the guidance process will be well received by industry.