FDA’s Center for Devices and Radiological Health (CDRH) recently released its 2012 Strategic Priorities, which includes a number of new initiatives and pilot programs designed to improve regulatory pathways and compliance processes as well as support new device-based innovation.
There will be a continued emphasis this year on globalization—harmonizing the regulatory process for medical devices across global regulators. The early months of 2012 should see the first meeting of the International Medical Device Regulators Forum, and CDRH pledges to propose a rule clarifying the use of foreign clinical data in the pre-market process before the end of the year.
Given the rising number of serious quality-related incidents, CDRH plans to implement its business-case-for-quality initiative to assess best manufacturing practices and areas for improvement of the FDA-industry relationship to assure quality compliance and patient safety.
CDRH will also be looking more closely at post-market performance of medical devices. By April 30th, it hopes to propose a comprehensive strategy to evaluate “real world device performance” that will be posted on the web. The public will have an opportunity to review and provide input to this initial strategy, which CDRH hopes to have finalized by the end of the year.
Finally, CDRH will continue to implement programs in an attempt to facilitate innovation among American scientists and entrepreneurs, including the Entrepreneurs in Residence (EIR) Program, which has tasked some of the industry’s most illustrious names with the development of the Innovation Pathway 2.0—a new regulatory process to expedite the review of device-based innovations to meet unmet medical needs. CDRH plans to begin implementation of this pilot regulatory pathway by March 31st. And on April 1st, the Triage of Pre-market Submissions Program will begin, with objectives to increase the efficiency of pre-market reviews and reduce the backlog of submissions and the resulting duration of the application process. By the end of 2012, expect new guidance on the pre-market process and the development of integrated technology—companion diagnostics, as well as cooperative drugs/biologics and devices.
We hope these proposed changes make it easier for Pearl and our for device clients to interact more effectively with FDA, submit pre-market applications in a more efficient and informed review process, and make use of foreign resources and data to advance technologies to market.
To view the FDA release, visit their website here.