FDA has raised the bar on real-world evidence (RWE) studies with its new draft guidance. FDA’s expectations that RWE studies be good quality, rigorous, and conducted under a protocol and with IRB approval are not new. But the depth of data assessment, documentation, and requirements for submission outlined in this guidance have been augmented beyond what may be reasonable. A greater desire by regulators for clinical data to support medical device safety and effectiveness is here to stay, not just at FDA, but globally. While the motivations are genuinely for the benefit of public health, the reality is that clinical and observational research is expensive, complicated, time consuming, and burdensome. These costs will ultimately be passed down to payers and patients. I am not sure the incremental confidence FDA has in its regulatory decisions is worth the cost.
Read MoreRequirements for clinical evidence of medical device safety and performance are increasing globally. Not only in Europe, but in Australia and the United States. For devices that have already been on the market in the United States, you may have an option you hadn’t thought of: a retrospective observational research study. This option is particularly useful for implants, but can be used for any medical device used by or prescribed by a clinician in the United States. Simply put, you can tap into existing medical records to gather sufficient clinical evidence of the safety and efficacy of your device. You just have to make sure you do it the right way.
Read MoreOn September 7, 2023, FDA released a new guidance document as part of the 510(k) modernization plan that sets out potential requirements for clinical data in pre-market submissions for Class II medical devices. This guidance should give pause to industry as the vague language appears to give FDA broad authority to request pre-market clinical data for Class II medical devices. The requirements appear to mimic what is happening in the EU under MDR where sufficient clinical data is necessary for a MDR CE mark of these same devices. Did the 510(k) program just get an EU MDR upgrade? If so, these new requirements will hamper innovation and delay patient access to new devices.
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