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Draft Guidance Documents To Facilitate Medical Device Studies In Humans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Administration (FDA) has issued a draft guidance aimed at fostering early-stage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The draft guidance “FDA Decisions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.
(Ref: http://www.pharmabiz.com/NewsDetails.aspx?aid=66038&sid=2)
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