From Food Court:
Nearly two years ago, the FDA’s Center for Devices and Radiological Health (CDRH) recognized the need to re-evaluate and modernize the regulatory review processes in order to assure that patients had timely access to safe and effective medical devices. In the CDRH Reportreleased yesterday it recognized three areas of improvement (see below).
Through its assessments and public input the CDRH identified several problems with pre-market programs, their root causes, and solutions. It stated that the agency would engage in an effort to make the necessary improvements to assure that pre-market programs are predictable, consistent, transparent, and efficient. Specifically, the agency stated it was in the process of: (i) creating a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks; (ii) assuring predictable and consistent recommendations, decision making, and application of the least burdensome principle; and (iii) implementing efficient processes and use of resources.
Overview of Actions CDRH is Taking to Improve Our Medical Device Pre-Market Programs
The actions we are taking can be grouped into three main areas of emphasis. Specifically, our actions seek to:
- Create a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks;
- Assure predictable and consistent recommendations, decision making, and application of the least burdensome principle; and
- Implement efficient processes and use of resources.
Although some of the specific actions described below would help achieve more than one of these goals, we placed each action into one the above three categories for purposes of this overview.