The AGA Center for GI Innovation and Technology is pleased to announce the launch of an initiative to develop observational research registries to help bring new medical devices to gastroenterologists and your patients.
It can take 7-10 years from device inception to Food and Drug Administration approval, and then an additional 2-4 years or more before payers provide coverage. "That’s too long for patients to wait for innovations that could change lives. AGA wants to facilitate processes and programs to speed up those timelines," said Dr. Pankaj J. Pasricha, chair of the AGA Center for GI Innovation and Technology who is also with Johns Hopkins.
Over the last decade, several technologies that could have improved gastroenterology care failed due to lack of guidance and support. As a neutral, objective broker, AGA will establish registries to help companies gather the data needed by payers, purchasers, risk-bearing organizations, and regulatory agencies to support the approval, coverage, reimbursement, and adoption of new technologies, therapies, and procedures.
Registries can provide data to allow stakeholders to evaluate efficacy of a device and document safety and durability. Strict methodology and structures must be applied to an observational registry to balance the needs of health care professionals, companies, payers, purchasers, regulatory agencies, AGA, and patients.
Dr. Ashish Atreja, assistant professor of medicine at Mount Sinai Hospital, will chair a subcommittee of AGA members who will oversee the initiative.
The AGA Center for GI Innovation and Technology does not endorse any product or service, develop guidelines, nor does it make any guarantees about FDA approval or coverage from public or private payers.
More information on this program is available at: gastro.org/deviceregistries gastro.org/deviceregistries
