By 2017 the process of evaluating products for approval under the 510(k) premarket notification policy will take only 124 days, down from the present 150 days. This and other proposals will be implemented by the Food and Drug Administration starting next year.
This is expected to benefit future recipients of medical devices and at the same time generate more funds for the agency through the increased fees. However, advocates still maintain that benefits derived from this will not justify the harm it can do to patients.
Across women's organizations, and even among recipients, the agency's 510(k) premarket notification has been, in part, held responsible for the debacle surrounding the transvaginal mesh. Under this regulation, medical products may be approved without pretesting as long as they are substantially similar to other models that have undergone testing.
According to complainants, this policy has left many patients in misery as a result of the implantation of vaginal meshes which were deemed defective yet approved through the agency’s 510(k) premarket notification program. To many of them, its continued implementation may do more harm than good despite the steps taken to improve it.
Read More: FDA Sets New Goals for Its 510(k) Medical Devices Approval Process
This is expected to benefit future recipients of medical devices and at the same time generate more funds for the agency through the increased fees. However, advocates still maintain that benefits derived from this will not justify the harm it can do to patients.
Across women's organizations, and even among recipients, the agency's 510(k) premarket notification has been, in part, held responsible for the debacle surrounding the transvaginal mesh. Under this regulation, medical products may be approved without pretesting as long as they are substantially similar to other models that have undergone testing.
According to complainants, this policy has left many patients in misery as a result of the implantation of vaginal meshes which were deemed defective yet approved through the agency’s 510(k) premarket notification program. To many of them, its continued implementation may do more harm than good despite the steps taken to improve it.
Read More: FDA Sets New Goals for Its 510(k) Medical Devices Approval Process