USA – US Regulatory Landscape for Medical Devices: A Year in Review and a Look Ahead

From a transition to the global standard for quality management systems (QMS) to the revamping of premarket review pathways in the US, the medical device industry can expect to see at least some regulatory initiatives that 2018 set in motion come to fruition in 2019.
 
The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) has released its list of guidances, indicating which topics will take precedence for 2019 policy clarifications. FDA’s new rulemakings agenda is out, as well. In the meantime, 2018 themes indicate the direction these plans are likely headed.
 
Regulatory harmonization and modernization took center stage this year, speaking to the measures of success in CDRH’s three-year policy roadmap from January and its recently updated medical device safety action plan.

An ongoing initiative that underscores the push for both harmonization and modernization relates to the proposed shift away from FDA’s QMS regulation toward ISO 13485:2016. A few details on these plans have trickled out in recent months, including a new 5% estimate on the potential overlap between the two approaches to QMS oversight. The gap analysis is reportedly set to be completed by early to mid-2019. 
 
Further, new rulemaking for a 13485:2016 transition is set for fall 2019. “The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements,” FDA said. They “will also modernize the regulation.” FDA’s latest updates on these plans were posted Wednesday, indicating that a transition period « will likely be a few years » and a wide-ranging impact to FDA…