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US FDA Issues Two Draft Guidance Documents To Facilitate Medical Device Studies In Humans

The US Food and Drug Administration (FDA) has issued a draft guidance aimed at fostering early-stage development of medical devices within the United States. Doing early-stage development is important to help stimulate US-based innovation and contribute to medical research.

The guidance document contains new approaches towards early feasibility studies, which are conducted in a small number of patients early in device development, while providing appropriate human subject protections. Such studies are necessary to resolve final design issues before the device is ready for a large clinical trial that is typically required for product approval. The FDA is seeking a small number of companies that could pilot the new approaches in the guidance. The results of the pilot will help to inform the final guidance.

Also the FDA issued guidance regarding clinical trials and medical devices. It describes the FDA’s process for approving applications from companies that want to conduct clinical trials involving medical devices.

“Approaches to regulation that facilitate early clinical experience with investigational medical devices can result in safe and effective devices that reach patients sooner and create incentives to innovate in the United States,” said Jeffrey Shuren, MD, director of the FDA’s Centre for Devices and Radiological Health. “Today’s guidance documents give sponsors and FDA device reviewers more flexibility to start investigational studies sooner while maintaining appropriate human subject protections, and they propose efficient ways to support product or study design changes once the study begins.”

Before investigators can proceed with a clinical study involving a medical device that poses significant risks to human subjects, the FDA must approve an Investigational Device Exemption (IDE). IDE approval allows a medical device to be studied on subjects who consent to being part of the investigation.

The draft guidance “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations” clarifies the FDA’s process for approving clinical trials of medical devices and includes:

When the FDA might allow patients to enroll in a study while issues are resolved, an approach called “approval with conditions.” Appropriate issues might include data analysis methods that can be resolved prior to gathering the data or minor divergences from study endpoints or study design assumptions.

The FDA might allow studies to begin with a smaller group of subjects while companies gather additional data, prior to the larger general enrollment, an approach called “staged approval.”

The draft guidance “Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, including First in Human (FIH) Studies” applies to medical devices in the early stages of development to better inform the final design of the device. It would allow studies to start earlier in the device development process than previously allowed. It would also permit for select device modifications to be made without FDA approval.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.


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