The U.S. FDA said in a May 27 statement that it has granted an emergency use authorization (EUA) to Clew Medical Ltd., of San Francisco, for the company’s software designed to screen emergency department patients for the likelihood that they will be diagnosed with COVID-19. The predictive screening algorithm is a standalone software as a medical device (SaMD) product that uses vital signs, lab data and other sources of information to determine the probability that the patient has been infected with the SARS-CoV-2 virus. The FDA said there are no approved or cleared devices that provide this function.
The U.S. FDA said that its plan to update the Electronic Medical device reporting (eMDR) includes the use of a revised version of form 3500A, part of a series of updates that will allow the public to more readily analyze adverse events in the agency’s Manufacturer And User Facility Device Experience (MAUDE) database. The update for form 3500A day includes new structured data fields that clarify whether a report represents multiple events, and a data fields to capture the number of events being summarized. The agency said the eMDR system will be updated to accommodate the new fields in form 3500A, but will also include adverse event codes to harmonize the system with terminology used published by the International Medical Device Regulators Forum.
The U.S. Government Accountability Office (GAO) said the Centers for Medicare and Medicaid Services is among four federal government agencies that have imposed conflicting cybersecurity requirements upon states that receive data from those agencies. The three other agencies in the GAO report are the IRS, the FBI and the Social Security Administration, and GAO said the four agencies had promulgated policies for cybersecurity requirements that were at odds with those developed by the other three agencies. A survey of state cybersecurity offices disclosed that the states experienced elevated cybersecurity compliance costs due to the unaligned cybersecurity policies, although the report also noted that the differences in cybersecurity policies are to some extent justified by differences in these agencies’ missions. GAO urged the Office of Management and Budget to encourage the agencies to align their policies where feasible, and said that CMS should revise its policies for assessing state cybersecurity requirements to maximize coordination with the other agencies “to the greatest extent practicable.”
Canadian Minister of Health Patty Hajdu issued an interim order Wednesday providing new flexibilities to accelerate clinical trials for potential COVID-19 therapies, devices and vaccines. The order expands who can conduct a drug trial beyond doctors and dentists to include other health care professionals such as nurse practitioners, according to Health Canada. It also allows doctors to serve as investigators in device trials, a role normally restricted to manufacturers. Other changes include reducing the burden associated with labeling and record-keeping requirements for clinical trials involving approved drugs that are being studied for a COVID-19 indication, enabling multiple-stream trials to continue even when one stream is stopped and allowing trials where direct interaction with the participant isn’t feasible. To date, Health Canada has approved 37 clinical trials for potential COVID-19 products.
In light of the hardships COVID-19 is imposing on small businesses and individual inventors, the U.S. Patent and Trademark Office (USPTO) is, for the third time, extending the deadlines for filing certain patent documents and paying fees. But this time the extension is only for small and micro entities. Under the extension, filings and payments due between March 27 and June 1, 2020, will now be due by July 1. After this month, large entities "should seek relief on a case-by-case basis, through the filing of a petition for an extension of time or a petition to revive, accompanied by any required fee," according to a USPTO notice.
A bill giving the directors of NIH institutes the same job protection as the heads of other independent U.S. agencies enjoy was introduced Wednesday in both the House and Senate. The National Institutes of Health Director Protection Act would ensure that heads of the NIH research institutes can only be removed for malfeasance, neglect of office or incapacity. House sponsors of the bill – Reps. Peter Welch (D-Vt.), Stephen Lynch (D-Mass.) and Gerry Connolly (D-Va.) – pointed out that the heads of agencies such as the Federal Trade Commissions and Social Security Administration already have that protection. The bill stems from concerns that Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, could be fired for providing scientific advice on dealing with COVID-19. Appointed to his position in 1984 under President Ronald Reagan, Fauci has served under six presidents – four Republicans and two Democrats. President George W. Bush awarded him the nation’s highest civilian honor, the Presidential Medal of Freedom.
The congressional Blue Dog Coalition wrote this week to U.S. House and Senate leadership, calling for a federal inquiry into the actions of the Chinese Communist Party at the onset of the COVID-19 outbreak and into how it might try to exploit the pandemic to advance its foreign policy objectives to the detriment of the U.S. and its allies. The coalition also endorsed legislation to establish a bipartisan commission to assess the U.S. preparation for and response to the pandemic, the Chinese government's errors at the onset of the outbreak and the U.S. over-reliance on China for critical supplies.
The U.S. FDA said Medtronic plc, of Dublin, is recalling the Heartware ventricular assist device’s pump outflow graft and graft strain relief components due to the risk that the outflow graft of the pump may tear. The consequence is that the strain relief screw may break during assembly of the device prior to implant, but this condition may go unobserved until the patient experiences an adverse event. Medtronic has received 92 complaints associated with the pre-implant pump assembly process, although the agency did not report any fatalities. The recall affects more than 4,900 units distributed in the U.S. between March 1, 2018, and April 1, 2029.