Are you complying with the new FDA General Wellness Policy for Low Risk Devices?
By Deb Bartel,
This post was recently updated on September 19, 2018
In July 2016, the FDA released Guidance for Industry and FDA Staff – General Wellness: Policy for Low-Risk Devices to clarify compliance policies for low risk products that promote a healthy lifestyle.
What’s in this FDA guidance document:
The purpose of a general wellness product
According to this FDA guidance, a general wellness product must
- Be intended only for general wellness use, and
- Must pose low risk to the safety of users and other persons.
What does the FDA consider to be a General Wellness Product?
General wellness products may include software programs, video games, exercise equipment, and other products that are commonly available from retail establishments or via direct software downloads.
This FDA guidance contains many examples of products that do and do not fall within the general wellness device category. The document also contains a decision algorithm for identifying general wellness products.
For more discussion regarding FDA’s regulatory approach towards certain mobile medical applications, see the FDA Guidance: Mobile Medical Applications, issued in 2015.
Download the FDA Guidance document here: General Wellness Guidance: Policy for Low Risk Devices, 9/16
Do you have a general wellness product? Talk to our CSV experts about how you might be affected.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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