The FDA’s Center for Devices and Radiological Health (CDRH) issued a new document on June 8 responding to the National Institute of Standards and Technology (NIST) call for position papers to fulfill the President’s Executive Order on improving the federal government’s cybersecurity. It details how CDRH is planning to do its part to advance the shared goal within medical devices.
With the next user fee agreement negotiations underway, device makers are not keen on a substantial hike in fee volumes. Nonetheless, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, has proposed a total product life cycle (TPLC) advisory function for the next user fee agreement, something he said would bring more predictability to industry and allow the agency to interact much more routinely with device makers.
The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access.
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome instruments for device evaluation.
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome (PRO) instruments for device evaluation. However, the draft is sufficiently vague on the question of when an existing PRO can be tweaked without an entirely new validation study to prompt the Advanced Medical Technology Association (Advamed) to press the agency for more clarity on that point.
The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.
The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
FDA warning letters to device makers have been conspicuous in their paucity in recent years, but they have been surfacing with greater frequency over the past few months.
Medtronic plc, of Dublin, has had a busy week. On Tuesday, it reported that it had received breakthrough device designation from the U.S. FDA for its Valiant TAAA stent graft system for the minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA).
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