U.S. Sen. Lamar Alexander (R-Tenn.) announced legislation that he said will help prepare the U.S. for the next pandemic, dubbed the Preparing for the Next Pandemic Act of 2020. The bill would provide $5 billion in funding over a decade to foster a manufacturing base for vaccines, treatments and tests, and another $10 billion over that same period for state stockpiles of items such as N95 masks. The legislation allows the federal government to collaborate with the private sector to ensure the Strategic National Stockpile has adequate inventories to meet the demand for various items and supplies, and Alexander said, “I intend to keep legislation to better prepare for future pandemics on the top of the congressional to-do list until it’s done.” Alexander chairs the Senate Health, Education, Labor and Pensions Committee.
The U.S. FDA has added five class II medical device types to the list of such devices that are exempt from premarket notification requirements under Section 510(k) of the Food, Drug and Cosmetic Act, a list that includes assisted reproduction accessories under product code QKH. This procode is regulated under Title 21, Section 884.6120 of the Code of Federal Regulations, but the agency said procode MQG, also regulated by 884.6120, is not exempt. Other product codes now deemed exempt are QKI (Section 884.6180), QKC (890.5360) and QKD (890.5670).
The Advanced Medical Technology Association (Advamed) said in a July 21 statement that it has released the first data set derived from a national testing supply registry intended to ensure the availability of tests for the COVID-19 pandemic. The registry was set up with the cooperation of more than a dozen commercial diagnostics manufacturers, and the first publicly released dataset indicates that more than 65 million tests have been manufactured and shipped in the U.S. since the beginning of the pandemic. Advamed said daily test shipments exceed 800,000. Scott Whitaker, Advamed’s president and CEO, said, “it is absolutely vital to our nation’s health and economic recovery that we have sufficient supplies to test everyone who needs it, and, just as important, to know where these supplies are so we can get them where they are most needed.” Whitaker said the registry “will be a crucial tool for federal and state authorities as they work to protect both patients and health care providers and move to reopen the U.S. economy.”
The FDA warning letter to Centurion Medical Products Corp., of Williamston, Mich., said the 2019 inspections of the company’s plants in Williamston and Howell, Mich., disclosed that the company is marketing convenience kits that are combination products that lack regulatory review. The kits are intended for use in “a variety of vascular and other medical procedures,” the agency said, adding that one of the kits in question includes lidocaine along with a scalpel, intravenous lines, and a needle. The company is said to assemble the kits from purchased products, and the FDA advised that any concomitant re-sterilization may compromise the safety and/or performance of one or more of the components. The agency also cited the company for deviations from the Quality Systems Regulations, including design controls, corrective and preventive action, and inadequate supplier evaluation procedures. The FDA advised Centurion that certificates for export may not be granted pending corrections, and that any PMA applications may also be held up pending those corrections.