CDRH Industry: Announcing the General Wellness: Policy for Low-Risk Devices Final Guidance and Webinar on September 1, 2016

Posted on Posted in News and Events, US FDA

Today, the FDA issued a final guidance document titled General Wellness: Policy for Low-Risk Devices.

The guidance explains that the FDA does not intend to actively regulate low-risk technologies that are intended only for general wellness use.  The FDA encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health. The FDA will continue to focus its oversight on medical devices that may pose inherent risks to a user’s safety.

Key changes from the draft guidance include:

  • Clarifying that CDRH’s general wellness policy does not apply to devices that present risks to users’ or other persons’ safety.
  • Identifying where the FDA will continue to focus oversight.  The FDA does not consider a general wellness product to be low risk if any of the following apply:
    • Is the product invasive?
    • Is the product implanted?
    • Does the product involve technology that may pose a risk to a user’s safety if regulatory controls are not applied, such as risks from lasers, radiation exposure, or electrical stimulation?

FDA Webinar to discuss the General Wellness:  Policy for Low-Risk Devices Final Guidance on September 1, 2016

The FDA will hold a webinar to help manufacturers understand the information provided in this final guidance document. Following a brief presentation, the FDA will respond to participants’ questions. We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required.

888-566-5974, passcode: 7768031
International Callers Dial: 1-210-234-0118 passcode: 7768031

To view the slide presentation during the webinar:
Participants can join the event directly at: https://www.mymeetings.com/nc/join.php?i=PW9442410&p=7768031&t=c
Conference number: PW9442410
Audience passcode: 7768031

To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will be available at this site on the morning of the webinar.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov1-800-638-2041, or 301-796-7100.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health