ACC, STS join FDA's Network of Experts to aid CDRH staff
To bolster the already abundant knowledge of the FDA’s Center for Devices and Radiological Health (CDRH) staff, the agency said that it will now incorporate a Network of Experts to help broaden scientific viewpoints.
The Network of Experts includes outside scientists, clinicians and engineers and aims to provide “rapid access to scientific, engineering and medical expertise when it is needed to supplement existing knowledge and expertise within the CDRH,” according to the FDA.
Currently, the FDA is running a 12-week pilot program of the Network of Experts that will add knowledge to the Expert Utilization and Expert Enrollment Standard Operating Procedures prior to the CDRH establishing an even larger Network of Experts this year.
Associations participating in the pilot include:
“Medical devices continue to become more diverse and complex. The CDRH Network of Experts will help us broaden our existing expertise and expose our staff to a variety of scientific viewpoints, especially on emerging technology,” William Maisel, MD, CDRH deputy center director and chief scientist, said in a statement.
While the members of the Network of Experts will not provide policy advice, they will share expertise on specific topics to help CDRH staff come to their own conclusions.
The FDA initiative is one of the 25 items on the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations that was announced last year. The FDA hopes that the initiative will add further transparency to the regulatory process.
The Network of Experts includes outside scientists, clinicians and engineers and aims to provide “rapid access to scientific, engineering and medical expertise when it is needed to supplement existing knowledge and expertise within the CDRH,” according to the FDA.
Currently, the FDA is running a 12-week pilot program of the Network of Experts that will add knowledge to the Expert Utilization and Expert Enrollment Standard Operating Procedures prior to the CDRH establishing an even larger Network of Experts this year.
Associations participating in the pilot include:
- The American College of Cardiology (ACC);
- American Institute for Medical and Biological Engineering (AIMBE); and
- The Society of Thoracic Surgeons (STS).
“Medical devices continue to become more diverse and complex. The CDRH Network of Experts will help us broaden our existing expertise and expose our staff to a variety of scientific viewpoints, especially on emerging technology,” William Maisel, MD, CDRH deputy center director and chief scientist, said in a statement.
While the members of the Network of Experts will not provide policy advice, they will share expertise on specific topics to help CDRH staff come to their own conclusions.
The FDA initiative is one of the 25 items on the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations that was announced last year. The FDA hopes that the initiative will add further transparency to the regulatory process.