Real World Evidence Leveraging the Submissions of Medical Devices

The safety and effectiveness of medical devices are ensured by the U.S. Food and Drug Administration as a part of the many ways it protects and promoted public health. The US FDA is advancing medical device innovation and assuring that patients have timely access to them. Medical products’ sponsors providing data from prospective randomized controlled trials have been considered the gold standard for a long.

However, many medical devices face practical limitations related to the device or disease condition’s alternative approach. The advances in the availability of real-world data (RWD) sources have increased the potential of generating robust real-world evidence (RWE). Real-World Data sources include electronic health records, registries, pharmacy data, medical claims, and feedbacks from wearables.

RWE is the clinical evidence that shows the usage, benefits, and risks of a particular medical product derived from the RWD analysis. RWD/RWE can demonstrate the real-life clinical performance of a medical product better than a clinical trial. This is because a clinical trial cannot evaluate all product applications in clinical practice across the full range of potential users.

The FDA’s Center for Devices and Radiological Health (CDRH) clarified how they evaluate the reliability and relevance of RWD. This helps understand whether they are sufficient to generate the types of RWE that can be relied on for the FDA regulatory decision-making medical devices.

RWE can be leveraged to bring in new products to the market, evaluate the product’s effectiveness and safety. They also assess the continued performance and security of the products.