-
Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.
-
The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006. The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.
-
On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.
-
On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.
-
On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.
-
On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.
-
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDER) announced that they have opened for all pre-submissions. During the pandemic, CDRH prioritized Emergency Use Authorization (EUA) for devices specifically related to the pandemic. In that same time, they also
-
The US Food and Drug Administration (FDA) released a guidance “Refuse to Accept Policy for 510(k)s” in April 2022. This guidance was originally issued in May 1994 and was previously updated in September 2019. The guidance describes the procedures the FDA uses to determine if a medical device premarket notification (510(k)) meets the minimum threshold of acceptability for their regulatory review.
The Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH) have announced efforts to modernize the 510(k) clearance pathway for medical device approval. Device manufacturers more frequently use the 510(k) pathway than other pathways to market. To gain market approval under 510(k), the manufacturer demonstrates that their device is substantially equivalent to an already marketed, or predicate, device. The 510(k) pathway is faster and easier than for devices that have no predicate. Modern devices are more technologically advanced than devices from even ten years ago. Because of its reliance on existing devices, there are concerns that following the 510(k) pathway may inhibit advancements in technology.
A new FDA Guidance on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics was released September 25, 2018. As devices become more complex, it becomes more difficult to determine if technological differences mean it is substantially equivalent to a predicate device. The guidance can be found on FDA’s website here.