Two recent items from the U.S. Food & Drug Administration show that someone at the agency has their eye on patients.
The first is the Patient Preference Initiative recently launched by FDA's Center for Devices & Radiological Health. The program aims to give a voice to "patient preferences" during FDA's regulatory process as it weighs the risks and benefits of the products it regulates.
The cool part about the Patient Preference Initiative is that it appears not to be a single point of review, but rather both consultative before products go to market and reflective after they are in the wild.
Michelle McMurry-Heath, MD, PhD, Associate Director for Science at FDA’s Center for Devices & Radiological Health, wrote in the FDA blog:
Patients, after all, are at the core of our mission and the focus of our vision.
The second is FDA's decision this week to better regulate some of the quickly growing list of mobile apps that are dedicated to health. FDA "intends to focus its regulatory oversight" on apps that perform critical health functions and could lead to patient harm.
Jeffrey Shuren, MD, JD, Director of FDA's Center for Devices & Radiological Health, said in a New York Times article:
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly.”
The two examples FDA gives are an app that would allow a caregiver to make a diagnosis by reviewing radiology images on a smartphone or tablet and an app that turns a smartphone into an electrocardiography (ECG) to detect heart rhythm abnormalities.
Applause to FDA for both of these moves that clearly put patients first.