On May 19, 2020, President Trump issued Executive Order No. 13924. This order instructed HHS and FDA to “review any regulatory standards that they have temporarily rescinded, suspended, modified, or waived during the public health emergency,” in order to “determine which, if any, would promote economic recovery if made permanent.” This included all devices that were applicable to the Emergency Use Authorization (EUA) Act. These devices include personal protective equipment and thermometer, as well as Computer-Aided Detection imaging systems (including lung computed tomography, chest X-ray, radiological computer-assisted triage, and Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, dry heat sterilizes, ventilators and infusion pumps).
As one of the last acts of the Trump Administration, the Department of Health and Human Services (HHS) is changing US Food and Drug Administration’s (FDA) regulatory oversight policies. The HHS announced that it is lifting premarket review requirements for seven Class I medical devices (all medical gloves) and proposes to waive such requirements for another 84, mostly Class II devices. Many of these 84 have been temporarily exempted from a longer premarket review during the COVID-19 public health emergency but have required an EUA review. Note: the HHS started with 184 devices, but was reduced to 91 devices based on MAUDE reportable events over the last 10 years.
According to the rule, within 120 days of publication, “the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice.” Since there is a lack of non-death-related adverse event reports for class II devices, HHS and FDA has determined that 510(k) premarket notification for the 84 class II devices and the unclassified device no longer necessitate the need a 510(k) to assure the safety and effectiveness of those devices. It is unclear if FDA will need to create an EUA-like rapid review process or, if by mandate, the devices will be completely 510(k) exempt and no review will be required before marketing the device.
Along with the adverse event, the HHS and FDA stated that estimates on the cost of preparing a 510(k) submission range from $100,000 to $4 million. This new exemption for these 91 device classes could eliminate anywhere from $9.1 to $364 million in startup costs. According to HHS, the savings could further accrue; instead of these costs being passed along to patients and hospitals, these savings could be invested in other areas such as research, development, and manufacturing. In addition, patients will gain more immediate access to new products that might be delayed due to 510(k) clearance delay. Lastly, the HHS said these exemptions will “conserve FDA’s scarce review resources” to be used with other riskier devices.
In their closing statement, HHS asked for further study of FDA’s review process and potential inconsistencies. FDA’s medical device Product Code database contains 6,651 unique codes and of those 157 are for class I devices that still require 510(k) clearance, and 2,662 are for class II devices that require 510(k) clearance, with many having few adverse reportable events. They also want the FDA to review the contradictions in the regulations. For example, although manual and electronic stethoscopes have the same intended use, electronic stethoscopes require a 510(K). Similarly, mercury thermometers used to measure oral, rectal, or axillary (armpit) body temperature are exempt from premarket review, but electronic thermometers which never enter into any body orifice require 510(k) premarket notification.
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