Jan 26, 2012

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published its 2012 Strategic Priorities, which include improvements to pre- and post-market processes, internal and external communications, and efforts to support innovative product development.

First, the regulator plans to complete implementation of its “Total Product Lifecycle Approach,” which entails taking into account “all of the relevant information available to the Center, at any stage of a product’s life cycle to assure the safety, effectiveness, and quality of medical devices,” according to the CDRH. This goal includes the following efforts:

  • Improving premarket reviews by better managing premarket review workloads; issuing proposed rules for when the CDRH could utilize clinical studies conducted in non-US markets; finalizing all guidances related to improving premarket programs; and evaluating CDRH staffing, infrastructure and policies related to medical software.
  • Addressing globalization challenges by participating in the first meeting of Global Harmonization Task Force successor the International Medical Device Regulators Forum, and by taking part in at least two harmonization efforts with non-US regulatory authorities this year.
  • Improve compliance capability by implementing “business-case-for-quality” initiatives such as best-quality manufacturing practices and determining further actions for 2013 as well.

Second, the CDRH plans to improve communication and transparency both among its internal staff and with various constituencies—patients, industry groups and health care providers.

  • Externally, the CRDH will enhance information exchange capabilities, improve feedback gathering and also establish a national forum for discussions with constituents.
  • Internally, standard operating procedures for information sharing among staff will be established.

Third, the CDRH intends to improve its workforce in terms of both employee education and satisfaction. For example, the division plans to launch its Experiential Learning Program (ELP) to improve staff knowledge of device design and manufacture, as well as its CDRH Leadership Enhancement and Development Program (LEAD) to improve managers’ and supervisors’ performance.

Fourth, the regulator plans to boost innovation to better meet public health needs as well as improve regulatory science.

  • Supporting innovative device development through initiatives including the Entrepreneurs in Residence program and Innovation Pathway 2.0 this year.
  • Developing personalized medicine programs by issuing guidance on Companion Diagnostics and co-development of drugs and devices.
  • Improving regulatory science via establishment of public-private partnerships between FDA, industry and academia, and through expansion of computer modeling and simulation to support device development and regulation.


  • Stewart Eisenhart