WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA) issued the following statement today regarding the FDA’s release of their “Plan of Action for Implementation of 510(k) and Science Recommendations:”
“We commend FDA leadership and staff for working with various stakeholders in an open and constructive process to develop consensus proposals that improve patient access to safe and effective therapies. As more details are provided on specific recommendations, MDMA will submit additional comments to FDA to help make the regulatory process more efficient and effective.
However, we remain concerned that FDA has deferred final decisions on key issues to the Institute of Medicine. Numerous stakeholders have expressed concerns with these proposals due to the adverse impact they would have on innovation, patient care and job-creation in the United States.
MDMA staff will continue to review this plan and its recommendations, and work with our members to ensure that all of their concerns are addressed. As we have said from the beginning, everyone benefits when a reasonable and predictable 510(k) process is in place.”
The FDA released its preliminary report on the 510(k) review process last summer, and this plan follows comments and input from MDMA and many other interested parties.
FDA’s plan and other supporting materials can be viewed by clicking here.