Dive Brief:

• A final rule from the EPA on commercial sterilizers that use ethylene oxide and an FDA proposal creating a category of over-the-counter hearing aids are among the regulatory items slated for completion by year's end, according to the Trump administration's Spring 2020 regulatory agenda released this week.
• Whether these initiatives come to fruition in 2020 remains to be seen. Many of the items were carried over from the Fall 2019 list. And as resources at federal agencies like FDA continue to be redirected to COVID-19 response efforts, it's possible the pandemic will again push back certain regulatory plans.
• Nonetheless, FDA's objectives by the end of September include issuing a proposed regulatory framework regarding placing holds on clinical investigations of medical devices, as well as final rules amending the Mammography Quality Standards Act, reforming the De Novo application process and updating radiological health regulations.

Dive Insight:

A comparison between the Fall 2019 edition of the regulatory agenda and the Spring 2020 version shows many of the Trump administration's proposed actions affecting medical devices are indeed the same.

One goal that carried over from last year was the Centers for Medicare and Medicaid Services' objective to make more efficient the path to coverage for certain breakthrough technologies, which in the latest agenda is tied to a June 2020 date after previously having a December 2019 target.

At FDA, a proposed rule creating a regulatory category for over-the-counter hearing aids is also on the list, with a deadline of August. That's delayed from a former November 2019 goal.

By September, FDA aims to put out a proposed framework on suspending or placing a hold on clinical investigations of medical devices. The agency also plans to finalize amendments to the Mammography Quality Standards Act, taking into account evolutions in mammography technology and processes that have occurred over the past two decades.

Yet another final rule would attempt to "establish procedures and criteria for the De Novo process and would make it more transparent and predictable for manufacturers," in hopes of saving time and money during the premarket requests and reviews.

The agenda also calls for FDA action on reclassifying specific device types including spinal spheres for use in intervertebral fusion procedures, more than minimally manipulated allograft heart valves and certain wound dressings.

Outside of HHS, the EPA plans to issue a proposal on ethylene oxide commercial sterilization in September, set to be finalized in December, which could affect how a large swath of device makers have their products sterilized. EPA issued an advanced notice of proposed rulemaking last December in which Administrator Andrew Wheeler appeared to acknowledge the device industry's concerns, noting in a statement "medical device sterilization is vital to protecting public health."

Calls from public health advocates that chemical emissions from sterilization plants can cause higher rates of cancer in surrounding communities threatened to restrict the industry's use of ethylene oxide. However, the urgent need during the pandemic to manufacture personal protective equipment and other products used in the fight against coronavirus has decreased some of that momentum, according to local reports.