Stakeholders Question HHS Premarket Notification Plan
Stakeholders are questioning the advisability of a 1/15 HHS notice stating that it is planning to exempt specified medical devices from 510(k) requirements, for which premarket review had been waived during the Covid-19 public health emergency. HHS said it wanted input on whether premarket review should be permanently waived for some or all of the 83 specified devices and views on ways to improve the 510(k) program. The notice was published in the Federal Register in the final days of the Trump administration.
The Medical Imaging and Technology Alliance (MITA) says the HHS notice did not provide the clarity MITA had sought on how products under a 4/2020 imaging guidance would be handled once the pandemic has ended. It says the notice creates confusion about manufacturer responsibilities concerning products cleared under public health emergency guidance documents. “We are further concerned that the policies and processes outlined in this notice may erode the public’s confidence in the safety and efficacy of the devices in question,” the comment letter says.
Otsuka says that most people, and certainly FDA, do not maintain that once a public health emergency is declared to have ended, the therapies used to mitigate the immediate effects of such crises should not have to undergo the more thorough, standard, FDA review process to remain on the market as safe and effective medical products. “The same should hold true here,” it says. “Several of the 84 subject device types may eventually be determined to warrant a permanent exemption, but the fact that some were granted exemption during the Covid-19 pandemic and that, during this short time period, they were not the subject of a large number of adverse event reports should not be the basis — or at least not the sole basis — for that significant determination.” The company suggests that FDA be given the time needed to carefully review the risks and benefits of exemption each of the specified device types from 510(k) clearance requirements in a manner that considers the nuances of each product type and its role in the delivery of health care.
The Baxter comment letter says it believes infusion pumps should be subject to 510(k) review and that infusion pump software also should be subject to testing, submission, and FDA review. It suggests there may be opportunities for review efficiencies and offers to work with FDA on such efficiencies.
Finally, the American Medical Association (AMA) says HHS should permanently withdraw the notice and work with FDA to determine which medical devices may be appropriate for exemption from premarket review. “The AMA strongly supports the work of FDA in this area and strongly believes decisions that would exempt medical devices from premarket review should rest with FDA officials who have expertise in this area,” the letter says. “The AMA also has concerns about the process used by HHS to justify these exemptions and believes that certain devices included in this notice are not appropriate for exemption.”