Top Story, Devices & Diagnostics

The FDA is now approaching patient engagement head-on with new advisory committee

The subject of patient engagement is getting its own division from the FDA with the creation of a new committee.

The Food and Drug Administration has decided to officially make patient care and input a priority with the development of a new advisory committee.

It recently announced its Patient Engagement Advisory Committee (PEAC), which will provide advice to the FDA Commissioner on issues involving medical devices, device regulation and patient use. The goal is to really put more focus on patient-related issues and increase communication about risks and benefits, specifically within the Center for Devices and Radiological Health (CDRH).

What the PEAC will provide includes studies to evaluate patient preferences in medical devices and a draft guidance on patient preference information for PMAs, HDE applications, de novo requests, and inclusion in device labeling that describes how patient tolerance for risk and perspective on benefit, in addition to clinical data and other information, may be considered in FDA’s assessment of the benefit-risk profile of certain devices, according to the FDA blog.

While the FDA obviously still holds the responsibility of making sure devices are safe, the new effort has been established reportedly:

  • to help identify the most important benefits and risks of a technology from a patient’s perspective;
  • to assess the relative importance to patients of different attributes of benefit and risk, and clarify how patients think about the tradeoffs of these benefits and risks for a given technology; and
  • to help understand how patient preferences vary across a population.

The growing focus on patient engagement rolls on.

Photo: Flickr user Seattle Municipal Archives