As such, the Agency stuck to familiar themes, for it has made recent moves in all three arenas. However, the FDA got specific in the new document, saying that by the end of the year it wants to increase the number of pre- and post-market that leverage real-world evidence by 40% this year, and 100% next year.
Real-world evidence can come from electronic health records, registries and medical billing claims, not clinical trials. CDRH head Dr. Jeffrey Shuren has in the past discussed the limitations of trial data, such as the tendency for patients to comply with all instructions for use due to the constant monitoring that occurs during the trial, but not in commercial use settings.
To have meaning in the context of devices, the sources or real-world (often post-market) data need to include unique device identification codes so that the equipment used can be identified, ideally to the level of a single device.
To that end, the FDA has a goal of gaining access to 25 million electronic patient records with device identification by the end of the year, and 100 million by the end of 2017. To meet the goal, the FDA must ensure that implementation of the UDI initiative goes smoothly, and that providers of EHRs and insurance claims data agree to integrate the information into their records.
Steps already taken to promote use of post-market data include the finalization of a Guidance on the balance between pre- and post-market data, guidance on communication about emerging signals of unknown clinical significance, and the release of a safety warning about an artificial heart based on a troubling post-market study. The latter was significant because the FDA often requires post-market studies as a condition of Premarket Approval (PMA), but they almost never result in agency warnings or enforcement action, something which it has come under fire for from patient safety advocates.
Finally, the FDA said that resources permitting, it will implement the recommendations about the creation of post-market surveillance monitoring system made by the Brookings Institution and the Medical Device Epidemiology Network.
The Agency also seeks to increase patient engagement, as evidenced by the recent launch of the patient engagement advisory committee. It wants all PMA decisions to contain information about available patient perspective data considered by September 2017. In addition, CDRH wants 90% of all employees to interact with patients as part of their job duties by the end of 2017.
Regarding manufacturing and device quality, the agency said it aims to increase the number of staff with “quality and process improvement credentials” over the next two years, and this year pilot voluntary use of product and manufacturing quality metrics and evaluation tools.
CDRH said it’s met its goals for 2015, related to strengthening the clinical trial enterprise, finding the right balance between pre-market and post-market data collection and providing excellent customer service.
REFERENCE: Fierce Medical Devices; 14 JAN 2016; Varun Saxena