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The Food and Drug Administration Feb. 8 launched a priority review program for new, breakthrough medical devices as part of the broader Innovation Initiative, a program to facilitate the development, assessment, and regulatory review of innovative medical devices.
According to FDA, the Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a product's timely progress to market.
“Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions,” Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement. “CDRH's Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs.”
Stephen J. Ubl, president and chief executive officer of the Advanced Medical Technology Association (AdvaMed), in a statement praised FDA “for its recognition of the vital role an efficient and predictable regulatory system plays in ensuring American patients have timely access to the latest treatments and cures and in helping the U.S. maintain its world leadership in medical innovation.”
Ubl said AdvaMed believes it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process and on addressing the full spectrum of concerns that have contributed to “unacceptable delays and inconsistencies which needlessly delay patient access to life-saving, life-enhancing medical technology.”
The agency announced a report on the initiative, as well as a March 15 public meeting to solicit feedback from stakeholders on select actions outlined in the report. Comments related to the meeting are due by March 15, but comments on the report are due by April 11, FDA said in a Federal Registernotice to be published Feb. 9.
Since improving the predictability of the premarket review programs is “our number one priority, CDRH will proceed in a manner that does not delay the implementation of critical actions to reduce uncertainty and that does not adversely impact our premarket review performance. Instead, we will implement the Innovation Initiative to the extent practical given current resources, and would consider expanding the Initiative should additional resources become available,” FDA said in the report.
According to the agency, the Innovation Initiative “proposes actions CDRH could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safely and based on sound science.”
Proposed CDRH actions include:
• facilitating the development and regulatory evaluation of innovative medical devices;
• strengthening the U.S. research infrastructure and promoting high-quality regulatory science; and
• preparing for and responding to transformative innovative technologies and scientific breakthroughs.
However, the agency said that resource constraints will affect its work. In light of FDA's numerous commitments to meeting the Medical Device User Fee Act (MDUFA) performance goals and improving the predictability of the current regulatory processes for getting devices on the market, the agency said that “expending significant resources to implement the Innovation Initiative is a luxury we cannot afford.”
As part of the initiative, CDRH proposed to establish a priority review program--the Innovation Pathway--for eligible innovative products.
According to FDA, the Innovation Pathway includes a number of key features designed to minimize delays that can occur when pioneering devices raise novel and challenging scientific questions. As a result, CDRH proposed a review time frame of 150 days--which is approximately half the time it takes to review most PMAs (premarket approval applications), the strictest form of approval for highest-risk devices.
CDRH's current regulatory pathways are designed to accommodate the incremental improvements manufacturers make to their marketed devices, FDA said, but the agency has not always met its targets for review times. The regulatory process allows manufacturers to modify existing devices and submit supporting data for regulatory review on a shortened time frame with the 510(k) program (known as premarket notification) and through the use of PMA supplements. The 510(k) process provides a streamlined review pathway for lower-risk new devices proven to be “substantially equivalent” to legally marketed predicate devices.
According to the report, the Innovation Pathway is intended to provide earlier investment of CDRH time and resources in devices that are “truly pioneering technologies and that have the potential to revolutionize patient care or health care delivery.”
To be eligible for consideration for the Innovation Pathway, CDRH said it would have to determine that the device is radically different from any legally marketed medical device in the United States in its underlying technology or manner of use.
“We anticipate that the devices reviewed under this pathway may raise scientific and regulatory questions that are novel, challenging and resource-intensive,” FDA said in the report. The agency said it anticipates the requirements it must meet under MDUFA, so as a result, the number of devices that can be accommodated under the Innovation Pathway would depend on available resources “so that our performance and commitments for the review of other devices are not adversely affected.”
CDRH said it anticipates that most devices that qualify for Innovation Pathway will be submitted for review as PMAs or through the de novo process, a mechanism for the classification of certain lower-risk devices for which there is no predicate.
Although the Innovation Pathway is a proposal for which CDRH is seeking public comment, the agency said it has accepted a pilot submission into the program: a revolutionary brain-controlled upper-extremity prosthetic designed to restore near-natural arm, hand, and finger function to patients suffering from spinal cord injury, stroke, or upper-extremity amputation.
The arm system, funded by the Defense Advanced Research Projects Agency (DARPA), will use 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, FDA said.
DARPA and the FDA have signed a Memorandum of Understanding addressing both the development and review of this project, FDA said.
FDA said it is not accepting additional applications for the Innovation Pathway until after it receives public feedback.
More information about the initiative and a copy of the report is at http://www.fda.gov/deviceinnovation.
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