About the public’s health
FDA Lifts Requirements for Masks, Respirators, Looks to Reprocessing to Ease Shortages: “FDA points out that face masks and respirators intended for general or industrial use and not intended for medical purposes are not considered medical devices and thus not subject to requirements under the Federal Food, Drug, and Cosmetic Act.
For face masks intended for a medical purpose that are not intended to provide liquid barrier protection, FDA says it is lifting major regulatory requirements to increase availability of the devices, including 510(k) submission, quality system regulation (QSR), registration and listing, and unique device identifier (UDI) requirements, so long as the devices do not create an undue risk for users.
FDA says it will allow the distribution and use of surgical masks, which are Class II devices, without 510(k) clearance, given that the masks meet certain standards for fluid resistance and flammability and include accurate labeling.” Also, millions of N95 masks are being found with more diligent searching. Some are expired but will be used if needed.
U.S. agencies to collaborate on wide-scale 3D printing of ventilator parts and medical supplies: “Alongside the National Institutes of Health and the Department of Veterans Affairs—as well as America Makes, the national accelerator program for additive manufacturing managed by the Department of Defense—the collective framework will look to help hospitals and others furnish components close to the patient or at the point-of-care.”
About health insurance
DOJ sues Anthem over Medicare Advantage fraud claims: “Anthem faces a federal lawsuit for submitting inaccurate diagnostic data to get a higher Medicare reimbursement.
The U.S. Attorney for the Southern District of New York said in the lawsuit filed late Thursday that Anthem failed to find and delete inaccurate diagnosis codes from 2014 to early 2018 through its ‘chart review program.’”
About pharma
Pfizer and Mylan Delay Merger Due to COVID-19: The headline speaks for itself.