Today, the U.S. Food and Drug Administration released a draft guidance document, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” The purpose of this guidance is to clarify how the FDA assesses benefits and risks for medical devices already available on the market.
This draft guidance focuses on the factors the FDA may consider when making decisions related to compliance and enforcement actions for a specific medical device company, or when making decisions that may affect a medical device’s availability on the market. In addition to evaluating scientific and clinical data, the FDA may also consider the patient perspective and other real-world data when determining a device’s safety profile.
The FDA believes the use of this information by medical device companies in their own benefit and risk assessments may help them to better determine when to initiate a recall, whether to correct a defective product or to remove it from the market.
We welcome your comments regarding this draft guidance. On Thursday, June 16, the notice of availability will publish in the Federal Register and will be open for 90 days.
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or email@example.com.
In addition, CDRH will hold a webinar on Monday, July 11, 2016 at 2:00 PM (Eastern Time) to answer questions regarding this draft guidance. No registration is required.
Food and Drug Administration
Center for Devices and Radiological Health