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“The best evidence is in the real world” - FDA taking steps to allow real-world data for medical device approval

Data produced by digital health tools such as wearables, remote monitoring tools, mHealth apps and others could soon lead to a shorter decision-making process during the regulatory clearance stage. The passage of the 21st Century Cures Act, sheds a new light on the usage of real-world evidence (RWE). Medical device companies will be allowed to demonstrate the safety and efficacy of new products by submitting observational and ‘in house’ registry data.

By providing insight into how devices perform in the real world, the collected evidence also has the potential to help device companies increase the scope for innovation and opens a new space for research opportunities.

Regulating medical devices can be difficult and there is a tendency to rely on pre-market evidence; however, this has limitations. Obtaining pre-market evidence is expensive, and processing it is time consuming. Despite this, a panel at the recent Connected Health Conference in Washington D.C. suggested that the large amounts of data produced by digital health tools could soon lead to a shorter decision-making process during the regulatory clearance stage.

Robert McCray, a senior advisor to the Personal Connected Health Alliance, emphasised this in his speech at the Connected Health Conference, saying that, “the best evidence is in the real world.” He also highlighted the recent policy developments that have supported further use of RWE, for example, the passage of the 21st Century Cures Act. This in turn supports the Precision Medicine Initiative and other similar programs, which depend on increased quality of RWE. Although, he went on to voice his concern that the problem was that there isn’t a way to collect and present data in a manner that would support medical device evaluation.

The FDA has also provided its input to the RWE debate. In July last year it released a draft guidance document on the use of RWE to support regulatory decision making. As well as this, FDA Chairman Robert Califf has described the topic as a top priority for the organization. Baku Patel, Associate Center Director for Digital Health at the FDA, provided further insight into the FDA’s intentions by explaining how it was looking to use RWE from software-based devices in the same way that many health professionals are already doing. Though he did sympathise with McCray’s scepticism by agreeing that assembling all the data in order to justify regulation is difficult.

It has become clear that companies who wish to pursue the RWE route must become comfortable working under the intense scrutiny of the FDA. However, early indications show that this might not be an issue. David Price, VP of Medical Affairs at Dexcom, said that his firm would welcome the opportunity, whilst simultaneously praising the FDA as both a helpful and useful organization. Mr Price went on to further outline the benefits of RWE, explaining how it had helped Dexcom identify other potential uses for their devices.

Using real-world data from patients allows companies to develop a more complete patient profile, providing them the ability to consult with clinicians and develop more tailored outcomes for patients. This, combined with the increased scope for innovation are the main reasons why RWE has grown in importance over the years. The main problem now lies with how companies use this data, and how they plan to process it in order to create the underlying foundations for regulatory decision-making.

Read the full article here.