Four priorities top FDAs medical device to-do list for 2012
Watch for the FDA’s Center for Devices & Radiological Health (CDRH) to focus attention on four areas of activity for the remainder of the current year:

  • Implementing a total product lifecycle approach;
  • Enhancing communication and transparency;
  • Strengthening its workforce and workplace; and
  • Facilitating innovation and addressing unmet public health needs.

CDRH announced the aims in a Jan. 24 document outlining its strategic priorities for 2012.

Expounding on its plan to improve communication and transparency with its stakeholders, CDRH pledged to “provide meaningful and timely information about the products we regulate and the decisions we make, through strategic outreach and systems that support transparency and two-way communication.”

The FDA branch also said it would develop and distribute “timely information about medical device and radiation-emitting electronic products that is useful to our external constituencies, using methods that meet their needs, while giving them opportunities to engage in a dialogue with the Center about the issues important to them.” It added that, by Dec. 31, it will have taken steps toward establishing a national forum for dialoguing with patients, consumers and healthcare professionals on issues that interest those groups.

When it comes to facilitating innovation and addressing unmet public health needs, CDRH said it will partner with various stakeholders to smooth a path for leading-edge medical devices that are shown to be both safe and effective.

“CDRH will make well-supported regulatory decisions that take into consideration 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, and the safety of non-device radiation-emitting products,” stated CDRH.