There are times when a casual observer can’t tell whether the medical device industry’s messaging is getting through to policymakers, but a July 17 announcement by the Trump administration clearly signals the effectiveness of at least one med tech messaging strategy.
In a move that undoubtedly has the unspoken support of the medical device industry, the U.S. Environmental Protection Agency (EPA) reported it will revisit several rules governing emissions that affect a broad swath of industries.
The U.S. FDA’s emphasis on alternatives to ethylene oxide is gaining momentum with the help of internationally recognized standards — such as ISO 11737 — in a move that will enable a less cumbersome approach to non-EtO device sterilization.
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.
The U.S. Environmental Protection Agency’s rulings on ethylene oxide emissions have drawn the ire of the device industry, but the chemical industry has weighed in as well.
The U.S. FDA and industry have been in scramble mode for some time to address the Environmental Protection Agency’s actions on ethylene oxide, but some manufacturers must also deal with other regulators’ perceptions of what constitutes an acceptable method of sterilization.
The U.S. FDA is holding a series of town halls on the use of sterilization methods as alternatives to ethylene oxide (EtO) in response to other federal agency rulemaking, and some of these changes in sterilization methods will not require a new regulatory filing.
The U.S. Environmental Protection Agency (EPA) has issued its long-awaited final rule governing emissions of ethylene oxide (EtO), a rule announced by the agency with the concurrence of Xavier Becerra, the Secretary of Health and Human Services. However, the final rule provoked an immediate response from Sen. Bill Cassidy (R-La.), who said the final rule will “put American lives in danger.”
The ongoing saga of the Environmental Protection Agency’s (EPA) pending rule on ethylene oxide (EtO) made its way to a Feb. 14 hearing in the U.S. House of Representatives, which included the testimony of Lishan Aklog of Pavmed Inc., who warned that a significant curtailment of EtO as a sterilant for medical devices could hamper patient access to medical devices.
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
