As part of a demonstration project launched via the National Evaluation System for health Technology Coordinating Center (NESTcc), the US Food and Drug Administration (FDA) is considering a national registry for implantable cardiac defibrillators (ICDs) to expand on its use of real-world evidence (RWE).
“This is a project that has been going on for more than a year, and very recently it got adopted by the NESTcc,” Gregory Pappas, associate director for National Device Surveillance at FDA’s Center for Devices and Radiological Health (CDRH) told Focus
He noted that FDA is in a transition period where agency staff are working on RWE use with the NESTcc, which also announced
11 projects—expected to be completed by the end of the year—in February.
NESTcc’s ICD Registry DELTA Active Surveillance Pilot Study is aimed at identifying alternative to studies that can be conducted following the approval or clearance of a device and involves the American College of Cardiology (ACC)—which hosts the national ICD registry on its website— the Lahey Hospital and Medical Center and CDRH.
It remains to be seen whether FDA will begin using an ICD registry, as a result of this pilot study, for RWE collection, Pappas added. But the use of registries can allow for “better, faster, cheaper” options for both industry and FDA staff for regulatory decision-making in terms of product reviews.
Pappas argued the collection and use of RWE through registries can be improved with the integration of unique device identifiers (UDIs) and this is something the ACC is “warming up to” regarding its registry.
As part of the FDA UDI final rule, most medical devices will be required to include UDIs in labeling designs and certain information must be submitted to FDA’s publicly available registry called Global Unique Device Identification Database (GUDID).
The UDI system – which will be phased in over the course of several years to give device makers time to prepare for compliance – has several implications, such as the costs associated with adoption and use, as well as the increased transparency.
Still, the agency believes
that harnessing the potential of adopting and integrating UDIs into health care delivery systems nationwide “will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.” The push for UDI has led to more integration into existing registries, according to Pappas. UDI use can also lead to improved supply chain management.
The real-world data obtained through the national UDI system can provide frameworks to help boost best practices in care delivery and medical device interventions – which may be particularly important and useful for higher-risk implantable devices, including ICDs.
For implantable, life-supporting or life-sustaining devices, industry compliance dates set for most UDI requirements have already passed, though FDA continues to work on addressing the “identified complex policy and technical issues that require resolution to help ensure that UDI data are high quality and are available in standardized ways,” the agency said in guidance
from earlier this year on UDIs for class I and unclassified devices, noting the approaching 24 September deadline
for certain UDI requirements.
FDA has continued to support the efforts others have made to launch registries. In 2015, CDRH Director Jeffrey Shuren said
the agency has been working to build the National Breast Implant Registry (NBIR).
The American Society of Plastic Surgeons is working on these efforts
in collaboration with FDA and manufacturers, with the intent of launching NBIR sometime this year “for the purpose of strengthening the post-marketing surveillance infrastructure for current and future breast implant devices.”
The launch of separate registries for implantable devices coincides with the high risk that they may pose to patients. Medtronic recently initiated
a nationwide recall involving 48 of its cardiac defibrillators – 12 of which are ICD models – over a manufacturing defect that may prevent the devices from delivering the medically needed life-saving, electrical shock therapies. Also, the first-ever FDA recall over cybersecurity risk
in 2017 relates to implantable pacemakers from Abbott.
GUDID System Updates
Meanwhile, FDA is also planning to implement updates to the GUDID system “based on user feedback and program needs,” with deployment tentatively set to begin early next month.
The plans include making the data in FDA premarket submission and supplement numbers publicly available as part of GUDID device identifier records via AccessGUDID and OpenFDA.
“The premarket numbers provide an essential link to information about device safety and effectiveness; making them public as part of the GUDID DI record information is crucial to achieving the public health benefits of UDI,” FDA said
, urging device makers to take immediate action.
Prior to the public release of the premarket numbers, set for the beginning of June, device makers are encouraged to “thoroughly review and if necessary, make changes to” the confidentiality designations submitted to the FDA Unified Registration and Listing System/Device Registration and Listing Module as the agency intends to use these to determine whether to make a number public in GUDID.