FDA Looks to Reduce Regulation, Layers of Review

Posted March 7, 2018

The medical device industry is asking the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) for more regulatory slack on issues ranging from labeling requirements to the reporting medical device malfunctions. Such requests echo the larger call for deregulation that has characterized Donald Trump’s presidency.

Within the first weeks of taking office, President Trump directed federal agencies through two executive orders, EO 13771, Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs, and EO 13777, Enforcing the Regulatory Reform Agenda, to reduce the cost and burden of regulations on industry and keep regulatory costs down.

“For every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process,” EO 13771 reads.

To comply with the two executive orders, CDRH requested public comments in September 2017 to help identify regulations and requirements that could be changed, repealed, or replaced  “to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations,” wrote the CDRH in a Federal Register notice.

In an extended comment period that ended in early February, CDRH received 24 responses from medical device manufacturers and industry groups. Most called for altering or curtailing regulations in ways that would provide them with more flexibility. Examples included allowing for the electronic labeling of drugs and medical devices, simplifying electronic records and data requirements, and greater ability to report medical device malfunctions using a summary format.

In a comment, the medical device trade association AdvaMed praised the FDA for conducting the review and outlined its suggestions to change regulations or requirements described as “outdated, redundant, or otherwise ineffective or inefficient."

“We commend the agency’s effort to review existing regulation and support efficient, effective regulation that supports scientific progress and timely access to critical medical technologies,” wrote Khatereh Calleja, AdvaMed’s senior vice president for technology and regulatory affairs. “We note that such measures will have positive impact for all innovators, particularly small company innovators that are often disproportionately impacted by outdated, inefficient regulation.”

The more hands-off regulatory approach adopted by the Trump administration fits into CDRH’s long-term plans to streamline processes and remove barriers to innovation that regulations may pose. In its 2018–2020 strategic priorities, CDRH announced plans to step back from its role as a regulator from a “command-and control gatekeeper” to a “representative, participatory government entity that serves and enables rather than dictates to the public, fosters a spirit of community, and rewards responsible conduct.”

“We believe that applying an approach of simplicity will enhance our decision making and allow us to make better use of our resources to focus more on what matters most to patients,” wrote CDRH Director Jeffrey Shuren in a blog post.

CDRH is looking to streamline its processes reduce “unnecessary burdens” on both industry and CDRH staff by making core processes leaner and increasing the agency’s agility. CDRH recently proposed an overhaul in its organizational structure that would focus on “big picture” regulation and minimize the layers of review needed to make decisions.