Excerpt from Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Excerpt on Real-World Evidence
The National Evaluation System of health Technology (NEST)’s vision is to create a system to generate better evidence more efficiently for medical device evaluation by leveraging RWE throughout the total product lifecycle.

Below, please find an excerpt from Draft Guidance for Industry and Food and Drug Administration Staff: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The full article may be viewed at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm513027.pdf

Real-World Data (RWD) is data collected from sources outside of traditional clinical trials. These sources may include large simple trials, or pragmatic clinical trials, prospective observational or registry studies, retrospective database studies, case reports, administrative and healthcare claims, electronic health records, data obtained as part of a public health investigation or routine public health surveillance, and registries (e.g., device, procedural, or disease registries). The data is typically derived from electronic systems used in health care delivery, data contained within medical devices, and/or in tracking patient experience during care, including in home-use settings.

Real-World Evidence (RWE) is the evidence derived from aggregation and analysis of RWD elements.

For medical devices, available evidence is traditionally comprised of non-clinical and, in some cases, clinical studies conducted and provided to FDA by the device manufacturer or sponsor. However, FDA recognizes that a wealth of data covering medical device experience exists and is routinely collected in the course of treatment and management of patients. Data collected during clinical care or in the home setting may not have the same controls for data quality and against biased results as data collected within a clinical trial setting. However, under certain circumstances, RWD may be of sufficient quality to help inform or augment FDA’s understanding of the benefit-risk profile of devices at various points in their life cycle. RWD, which are typically collected for non-regulatory purposes in electronic health records (EHRs), registries, and administrative and claims data, may provide new insights into the performance of medical devices. The information obtained could potentially be used to aid FDA in regulatory decision-making.

FDA has issued guidance on balancing premarket and postmarket data collection, understanding benefit-risk determinations, and expedited access to medical devices for unmet medical needs in an attempt to streamline the process for bringing new technologies to market while assuring robust evidence generation and applying appropriate controls to ensure the continued safety and effectiveness of medical devices. FDA has also issued plans for and has begun implementation of a national evaluation system that leverages RWD to more quickly identify safety problems, to better understand the benefit-risk profile of devices used in clinical care, and to reduce the time and cost of evidence generation to inform FDA premarket approval and clearance.” i

i http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm513027.pdf