The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.
A thin film electrode platform technology developed by Neuroone Medical Technologies Corp. could be used to treat chronic back pain according to new tests. Eden Prairie, Minn.-based Neuroone said it concluded initial testing that demonstrate the electrode could provide chronic stimulation at typical stimulation parameters currently used to treat patients suffering with chronic back pain due to multiple failed back surgeries.
The U.S. FDA does not have legal authority to impose recalls on most regulated products, making the March 3 final guidance for voluntary recalls a key policy declaration for industry. The guidance recommends that recalling firms make extensive use of electronic communication to announce a recall, but the referenced FDA guidance for electronic communications was finalized in 2006 and makes no reference to social media as an electronic conduit for recall information.
The FDA’s proposal to harmonize the Quality System Regulation (QSR) with ISO 13485 has finally become more than just a hot topic among device makers, and the agency held a March 2 advisory hearing on the matter. One of the critical concerns for industry is the proposal of a one-year term of implementation upon publication of a final harmonization rule, a timeline that some argue should be doubled or tripled in order to serve as a practicable implementation timeline.
A Seattle-based startup has secured breakthrough device designation for its blood-based Alzheimer’s disease (AD) test. Altpep Corp.’s Soba-AD platform is designed to selectively detect toxic forms of amyloid-beta peptide associated with AD progression. The company said early data indicated the assay can detect AD before symptoms including cognitive impairment and neurodegeneration arise.
Small American device manufacturers are more likely to sell their products only in the U.S., and thus the FDA proposal to more closely align the Quality System Regulation (QSR) with ISO 13485 would seem to place unwarranted demands on these companies.
The FDA has published an updated guidance for the appeals process at the Center for Devices and Radiological Health, but the issuance of that guidance did not happen in a vacuum. Mark Duval, president of Duval & Associates in Minneapolis, told BioWorld that industry is filing more appeals of premarket decisions of late, an uptick he said is an artifact of the practice of FDA reviewers more commonly asking for additional data for these applications.
Medtronic plc has launched a single-use device for outpatient-based treatment of chronic, obstructive Eustachian tube dysfunction (ETD). Medtronic’s FDA-approved Nuvent system is a manually controlled balloon catheter for insertion into the Eustachian tube canal. Once pressurized, the balloon expands and dilates the Eustachian tube canal to relieve symptoms of ETD.
The U.S. Patent Trial and Appeal Board’s (PTAB) decision Feb. 28 that Broad Institute scientists were the first to invent the use of CRISPR/Cas9 genome editing in eukaryotic cells is just another chapter in the ongoing saga of who has patent rights to various elements of the CRISPR platform.
The U.S. FDA’s device center has posted a report on premarket review performance metrics under the current device user fee schedule, and the latest data show an 83% rate of deficiency in first-cycle reviews of PMA original filings in the last three months of calendar year 2021. That rate is down somewhat from the 91% rate seen in 2016, but is up substantially from the 63% major deficiency rate seen in 2018, the low-water mark for this metric for more than a decade.
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