OIG Report on FDA’s Postmarket Surveillance of Devices Coming in 2020

Regulatory NewsRegulatory News | 17 October 2019 |  By 

The US Department of Health and Human Services’ Office of Inspector General (OIG) will issue a report next year on the US Food and Drug Administration’s (FDA) postmarket surveillance of medical devices, which has come under fire in recent months.

OIG says it will assess and describe how FDA's “established passive postmarket surveillance system” identifies and tracks safety concerns and responds to them.

“We will also describe how elements of FDA's newer surveillance system initiatives, such as the Unique Device Identification system, are being integrated into the passive postmarket surveillance system. In addition, we will describe how FDA plans to integrate these initiatives into the National Evaluation System for health Technology [NEST], its in-development active postmarket surveillance system,” OIG said.

UDI compliance dates were pushed back by FDA for several different classes of devices over the past several years, but compliance dates for Class III and implantable devices took effect in 2016 and 2015, respectively.

Meanwhile, FDA’s work with NEST has continued to progress. FDA also recently said that revised draft guidance on postmarket surveillance is coming in 2020.

But the announcement of an OIG report on postmarket surveillance also follows FDA’s decision in May to end an alternative summary reporting program after a Kaiser Health News investigation showed how FDA had collected 1.1 million reports through the program since 2016. And back in 2018, OIG found flaws in FDA’s postmarket cybersecurity procedures.

“It is more important than ever that FDA's postmarket safety surveillance system can effectively identify and act on safety signals,” OIG said.

OIG is also working on reports for 2020 related to FDA’s inspections of manufacturing plants overseas and FDA’s oversight of Risk Evaluation and Mitigation Strategies for addressing opioid abuse.

Device Servicing vs. Remanufacturing

Meanwhile, Sens. Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) sent a letter earlier this month to Acting FDA Commissioner Ned Sharpless on the agency’s plans to clarify, communicate and enforce the distinction between medical device servicing and remanufacturing, especially as some servicers may not realize that they are actually remanufacturers subject to more stringent regulation.

FDA said that draft guidance is coming in 2020 on, “Distinguishing between Medical Device Servicing and Remanufacturing.”

The senators ask: “If so many entities believed to be involved in ‘servicing’ are actually ‘remanufacturing’ devices, and FDA has said ‘the precise number of entities that perform servicing of medical devices in the U.S. is not known,’ how does FDA intend to identify the universe of actors to whom its upcoming guidance will apply?”

They also want to know what surveillance mechanisms are available to the agency to detect servicers who are also performing remanufacturing and what FDA does when it finds an unregistered entity engaging in remanufacturing.

An Assessment of the U.S. Food and Drug Administration's Postmarket Surveillance of Medical Devices

Warren and Cassidy Letter


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