As expected based on retrospective data, new results from an ongoing postmarket study has found Bayer’s Essure birth control device has significantly higher rates of major adverse events compared to women who undergo tubal ligation.

Democratic lawmakers argue the Trump administration’s interpretation of how COVID-19 testing is covered by private insurers runs contrary to the Families First Act and CARES Act. They want the administration to update a FAQ sheet that eliminates certain prerequisites that would qualify patients to be reimbursed for the tests.

As the US sees another massive spike in COVID-19 cases, public health officials are concerned that not enough testing is available. But the FDA’s EUA for BD’s antigen test could change the game, rapidly testing more of the population for the coronavirus.

Tests may need to be pulled from the shelves if the COVID-19 Public Health Emergency isn’t renewed before it would expire this month, device lobby group AdvaMed claims. But HHS has indicated plans to renew the order.

Due to the ongoing coronavirus crisis, regulators have put pushed back deadlines for meeting UDI requirements. In some instances, they will no longer require direct-mark UDI information if it can be garnered from other data on the device.

The sixth Medical Device Development Tool qualified by the US FDA allows makers of artificial pancreases to provide data on psychosocial effects and quality-of-life changes of patients using their product. Ultimately, it may be the key to whether the agency allows the product on the market or not.