The U.S. FDA’s device center posted an enforcement policy for infusion pumps and accessories to address the COVID-19 outbreak, which is in force only during the public health emergency declared under Section 319 of the Public Health Service Act. The scope of the guidance covers four infusion pump product codes, including procodes FRN and MEA, and more than 20 procodes for accessories, including MAJ and KPE. The policy allows for “limited modifications” to indications for use, device functionality, and hardware, software and device design without the normal premarket notification via the 510(k) pathway. Those modifications can include changes to functionality undertaken to facilitate remote patient monitoring and remote adjustment to infusion pump settings. The guidance also provides guidelines for device use beyond labeled shelf life, and the agency requested that makers of pumps not currently approved or cleared in the U.S. forward information about those products to the agency.
Mimedx Group Inc., of Marietta, Ga., said in an April 6 statement that it has finalized a settlement with the U.S. Department of Justice which resolves an investigation regarding the accuracy of commercial pricing disclosures to the U.S. Department of Veterans Affairs. The item in question appears on a federal supply schedule contract with the government, but is also the subject of a qui tam lawsuit filed in the state of Minnesota. Mimedx said it had disclosed the matter to the Veteran’s Affairs inspector general’s office in November, prior to the company’s awareness of an impending qui tam lawsuit. The company has agreed to pay $6.5 million to settle the matter without admitting the allegations, and that this amount had already been anticipated in securities filings. The associated DoJ statement indicates that the whistleblowers will receive in excess of $1.6 million.
The FDA said in an April 3 statement that certain imported filtering facepiece respirators (FFRs) are appropriate to use under the existing emergency use authorization. The letter, directed to device makers, importers, hospital administrative staff and others, says that FFRs imported from China that are not authorized by the National Institute of Occupational Safety and Health (NIOSH) can be used per directives issued by the CDC.