FDA NEWS RELEASE
For Immediate Release: Feb. 8, 2011
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA launches Medical Device Innovation Initiative
DARPA-funded prosthetic is first test case
DARPA-funded prosthetic is first test case
Today the U.S. Food and Drug Administration proposed the Innovation
Pathway, a priority review program for new, breakthrough medical devices
and announced the first submission: a brain-controlled, upper-extremity
prosthetic that will serve as a pilot for the program. The FDA also
announced plans to seek further public comment before the Pathway can
be used more broadly.
Pathway, a priority review program for new, breakthrough medical devices
and announced the first submission: a brain-controlled, upper-extremity
prosthetic that will serve as a pilot for the program. The FDA also
announced plans to seek further public comment before the Pathway can
be used more broadly.
The new proposed Innovation Pathway program for pioneering medical
devices, highlighted in a report published on the FDA’s website today,
is part of a broader effort underway in the FDA’s Center for Devices and
Radiological Health (CDRH) designed to encourage cutting-edge
technologies among medical device manufacturers.
devices, highlighted in a report published on the FDA’s website today,
is part of a broader effort underway in the FDA’s Center for Devices and
Radiological Health (CDRH) designed to encourage cutting-edge
technologies among medical device manufacturers.
The initiative will also seek to strengthen the nation’s research
infrastructure for developing breakthrough technologies and advancing
quality regulatory science. Proposed actions include:
infrastructure for developing breakthrough technologies and advancing
quality regulatory science. Proposed actions include:
• establishing a voluntary, third-party certification program for U.S.
medical device test centers designed to promote rapid improvements
to new technologies during a product’s development and clinical testing
stages;
• creating a publicly-available core curriculum for medical device
development and testing to train the next generation of innovators; and
• using more device experience and data collected outside the United
States.
medical device test centers designed to promote rapid improvements
to new technologies during a product’s development and clinical testing
stages;
• creating a publicly-available core curriculum for medical device
development and testing to train the next generation of innovators; and
• using more device experience and data collected outside the United
States.
In addition, CDRH intends to engage in formal horizon scanning –
monitoring medical literature and scientific funding in a systematic way
to predict where technology is heading. CDRH will include public input
in this process to prepare for and respond to transformative innovative
technologies and scientific breakthroughs.
“Each year, millions of American patients benefit from innovative medical
devices that reduce suffering and treat previously untreatable conditions,”
said CDRH Director Jeffrey Shuren, M.D., J.D. “CDRH’s Innovation Initiative
will help accelerate the development of and patient access to innovative
medical devices, which often fulfill unmet public health needs.”
monitoring medical literature and scientific funding in a systematic way
to predict where technology is heading. CDRH will include public input
in this process to prepare for and respond to transformative innovative
technologies and scientific breakthroughs.
“Each year, millions of American patients benefit from innovative medical
devices that reduce suffering and treat previously untreatable conditions,”
said CDRH Director Jeffrey Shuren, M.D., J.D. “CDRH’s Innovation Initiative
will help accelerate the development of and patient access to innovative
medical devices, which often fulfill unmet public health needs.”
The FDA has accepted its first submission from the Defense Advanced
Research Projects Agency (DARPA) to review a brain-controlled,
upper-extremity prosthetic designed to restore near-natural arm, hand
and finger function to patients suffering from spinal cord injury, stroke
or amputation. The arm system uses a microchip implanted on the
surface of the brain to record neuronal activity and decode the
signals to actuate motor neurons that control the prosthesis. DARPA
and the FDA have signed a Memorandum of Understanding addressing
both the development and review of this project.
Research Projects Agency (DARPA) to review a brain-controlled,
upper-extremity prosthetic designed to restore near-natural arm, hand
and finger function to patients suffering from spinal cord injury, stroke
or amputation. The arm system uses a microchip implanted on the
surface of the brain to record neuronal activity and decode the
signals to actuate motor neurons that control the prosthesis. DARPA
and the FDA have signed a Memorandum of Understanding addressing
both the development and review of this project.
The proposed Innovation Pathway program includes the following features:
• products would have to be truly pioneering technologies with the
potential of revolutionizing patient care or health care delivery;
• selected products would receive an Innovation Pathway memorandum
from CDRH containing a proposed roadmap and timeline for device
development, clinical assessment and regulatory review; and
• products would be assigned a case manager, their important scientific
issues would be identified and addressed earlier in the development process,
and they might be able to qualify for flexible clinical trial protocols.
potential of revolutionizing patient care or health care delivery;
• selected products would receive an Innovation Pathway memorandum
from CDRH containing a proposed roadmap and timeline for device
development, clinical assessment and regulatory review; and
• products would be assigned a case manager, their important scientific
issues would be identified and addressed earlier in the development process,
and they might be able to qualify for flexible clinical trial protocols.
Applications would be reviewed by the Center Science Council, a new
oversight body currently being developed within CDRH comprised of senior
managers and experienced scientists, who would facilitate this device
development and evaluation process. Enrollment in the Innovation Pathway
program would not change the scientific or regulatory standards that
CDRH would use to evaluate device submissions and determine their
appropriateness for marketing.
oversight body currently being developed within CDRH comprised of senior
managers and experienced scientists, who would facilitate this device
development and evaluation process. Enrollment in the Innovation Pathway
program would not change the scientific or regulatory standards that
CDRH would use to evaluate device submissions and determine their
appropriateness for marketing.
Because of the transformative nature of the devices that would be eligible
for this pathway, CDRH expects them to generally be approval pathways
intended for either high risk or novel products.
for this pathway, CDRH expects them to generally be approval pathways
intended for either high risk or novel products.
The FDA could conduct premarket reviews of products in the Innovation
Pathway within 150 days, nearly half the time it currently takes the FDA
to review most premarket approval applications.
Pathway within 150 days, nearly half the time it currently takes the FDA
to review most premarket approval applications.
CDRH has set up a public docket to solicit public comment on the
Innovation Initiative and will host a public meeting on the topic on
March 15, 2011 at the Center’s White Oak campus.
Innovation Initiative and will host a public meeting on the topic on
March 15, 2011 at the Center’s White Oak campus.
For more information:
- CDRH Medical Device Innovation Initiative at
http://www.fda.gov/deviceinnovation
Links from the FDA website
Medical Device Innovation Initiative Documents
Medical Device Innovation Initiative White Paper Questions and Answers about the Medical Device Innovation Initiative Innovation Initiative Remarks - Jeffrey Shuren, M.D., J.D., Director FDA's Center for Devices and Radiological Health Federal Register: Medical Device Innovation Initiative; Request for Comments
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Opportunities to Comment on the Medical Device Innovation Initiative
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