Jun 26, 2019

The US Food and Drug Administration’s medical device oversight division has ended reporting exemptions for some manufacturers and made more report data publicly available in an effort to boost transparency and better monitor product safety.

The agency’s Center for Devices and Radiological Health (CDRH) recently announced an overhaul of its Medical Device Reporting (MDR) program. The overhaul includes ending CDRH’s Alternative Summary Reporting (ASR) program, establishing its Voluntary Malfunction Summary Reporting (VMSR) program as a primary reporting channel for manufacturers, and updating the agency’s MAUDE database to be more user-friendly as part of a broader MDR system modernization effort.

ASR program closure

The ASR program, started in 1997, manufacturers of qualifying devices were allowed to request exemptions from individual medical device report filing requirements, and submit quarterly summary reports of well-known events with well-established related risks instead. Over the past two years, CDRH has wound down the ASR program; only 13 manufacturers (producers of dental implants, implantable cardiac defibrillators and pacemaker electrodes) were participating in the program upon its cessation this year.

Following FDA’s formal ending of the ASR program, the agency has made all reports submitted under the program between 1999 and 2019 publicly available via the MAUDE database.

Voluntary Malfunction Summary Reporting

As FDA began sunsetting the ASR program in 2017, the agency also began ramping up another medical device reporting program, the Voluntary Malfunction Summary (VMSR) program, wherein manufacturers voluntarily provide summary reports on device malfunctions other than those involved in deaths or serious injuries in summary form every quarter.

The VMSR program is intended to allow CDRH to allocate more resources to monitor device-related incidents that may pose more serious risks to public health, according to the agency.

MAUDE modernization

Over the near term, FDA also plans updates to MAUDE to boost usability of MDR data as well as make such information more easily searchable in the database. Implementation of MDR information technology systems upgrades including those for MAUDE began in 2019, and will continue contingent upon funding from Congress.

Towards “active surveillance” for medical device safety

Despite these moves to make medical device reporting programs more transparent, FDA notes that MDR data must be supplemented with other efforts—Unique Device Identification and ongoing development of the National Evaluation System for health Technology (NEST), for example—in order to promote “modernized, active surveillance that utilizes real-world data” for medical device safety signal detection, states the agency.

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  • Whitepaper: Implementing a medical device post-market surveillance program