The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance.

Damage to the left ventricle may be more common than damage to its cousin on the other side, but right heart failure is still a unique syndrome with its own specific needs. Chuck Simonton, the chief medical officer at Abiomed Inc., told BioWorld that both the company and the U.S. FDA are keen to remind cardiologists that early detection and treatment of right heart failure vastly improves outcomes, including a huge reduction in mortality in these desperately ill patients.

The U.S. CMS has posted a second draft rule that would streamline prior authorizations by Medicare Advantage insurers, a move sure to draw support from patients and clinicians alike. This would be achieved by requiring that payers adopt the Health Level 7 interoperability standard, a requirement that may take every bit of the three years to achieve before a final rule would go into effect under the terms of the proposed rule.

Medical device manufacturers that hire outside counsel to conduct investigations of a facility’s quality system can expect an outsider’s view and might have the benefit of more candor on the part of quality staff than would otherwise be available.

The U.S. Office of Inspector General examined the volume of tests for allergies and respiratory pathogens conducted during the COVID-19 pandemic, and found a few outlier testing labs that billed a conspicuous volume of such tests. While the agency recommended that the CMS examine these claims more closely, the results also suggest that enforcement action may be en route for the more than 160 labs identified as having filed a higher than typical volume of claims for these tests.

The conviction and sentencing of Elizabeth Holmes and Sunny Balwani of Theranos Corp. might be seen as an example of retribution for testing technology that didn’t exist and thus endangered patients, but that perception doesn’t stand up to scrutiny.

The U.S. Department of Justice (DOJ) has developed a number of policies related to corporate misconduct over the past couple of decades, some of which were stood up only to be reversed a short time later.