Welcome to today’s

FDA/CDRH Webinar

Thank you for your patience while we 

register all of today’s participants.

If you have not connected to the audio 

portion of the webinar, please do so now:

Dial: 888-566-5974, passcode: 7768031

International Callers Dial: 1-210-234-0118 

passcode: 7768031
General Wellness Guidance: 

Policy for Low Risk Devices

Presenter: Simon Choi, PhD, MPH

Senior Science Health Advisor, Office of the Center Director

Center for Devices and Radiological Health

September 1, 2016 Webinar
3

Agenda

• Overview of General Wellness Guidance

• Q& A
4

Background

• Draft Guidance on General Wellness 

published January 20, 2015

• We received 12 comments

• Basic tenets of guidance remain unchanged

• Final guidance published on July 29, 2016
5

Overview – Big Picture

• The FDA encourages the development of general wellness 

products such as fitness trackers, which can empower 

individuals to take a more active role in managing their 

health. 

• The FDA’s Final Guidance on General Wellness takes a 

hands-off approach to the regulation of low risk general 

wellness products that only promote a healthy lifestyle or 

that promote a well-known association between a healthy 

lifestyle and a certain disease or condition.

• The FDA will continue to focus its oversight on products that 

are invasive, implanted or pose greater risks to patients, 

even if they are intended for general wellness purposes. 
6

Overview-Key Principle

CDRH does not intend to examine low risk general wellness 

products to determine whether they are devices within the 

meaning of the FD&C Act or, if they are devices, whether they 

comply with the premarket review and post-market regulatory 

requirements for devices including, but not limited to: 

• Registration and listing and premarket notification 

requirements (21 CFR Part 807); 

• Labeling requirements (21 CFR Part 801 and 21 CFR 

809.10);

• Good manufacturing practice requirements as set forth 

in the Quality System regulation (21 CFR Part 820); and 

• Medical Device Reporting requirements (21 CFR Part 

803). 
7

Definition

General wellness products are defined as products 

that meet the following two criteria: 

1. Are intended for only general wellness use 

AND

2. Present a low risk to safety of users and other 

persons.
8

Low Risk General Wellness Product

General 

Wellness 

Claim only

Low Risk

Low Risk 

General 

Wellness 

Product
9

Low risk

1 Product is not invasive &

2 Product is not implanted &

3 Product does not pose risk (involve intervention or technology that may pose a risk 

to safety of users and other persons if regulatory controls were not applied)

General Wellness Claim

Intended use relates to 

maintaining or encouraging 

healthy lifestyle

Intended use relates to 

Healthy Lifestyle with 

reference to 

disease/condition

Healthy lifestyle choices may 

play an important role in 

health outcomes for the 

disease or condition; 

outcome well understood

Claim Healthy Lifestyle Role in outcomes
10

General Wellness Intended Use

A general wellness product, for the purposes of this guidance, 

has:

(1) an intended use that relates to maintaining or 

encouraging a general state of health or a healthy activity, or 

(2) an intended use that relates the role of healthy lifestyle

with helping to reduce the risk or impact of certain chronic 

diseases or conditions and where it is well understood and 

accepted that healthy lifestyle choices may play an 

important role in health outcomes for the disease or 

condition.
11

First Category of Intended Use

• Relates to maintaining or encouraging a general 

state of health or a healthy activity 

• Does NOT make any reference to diseases or 

conditions.

Examples include:

Claims to promote or maintain a healthy weight, encourage 

healthy eating, or assist with weight loss goals;

Claims to promote relaxation or manage stress;

(See section III for additional examples)
12

Examples of First Category of 

Intended Use

No mention of disease or condition

• Claims to promote relaxation or manage stress

• Claims to improve mental acuity, instruction 

following, concentration, problem-solving, 

multitasking 

• Claims to enhance learning capacity
13

Examples of First Category of 

Intended Use

• Claims to promote physical fitness, such as 

to help log, track, or trend exercise activity

• Claims to promote sleep management, such 

as to track sleep trends 

• Claims to promote self-esteem
14

Second Category of 

Intended Use

Relates the role of healthy lifestyle with helping to reduce the 

risk or impact of certain chronic diseases or conditions and 

where it is well understood and accepted that healthy lifestyle 

choices may play an important role in health outcomes for the 

disease or condition. 

• Makes reference to diseases or conditions

• Two subcategories: 

1. Promote, track, and/or encourage choice(s), which, as part of a healthy 

lifestyle, may help to reduce the risk of certain chronic diseases or 

conditions

2. Promote, track, and/or encourage choice(s) which, as part of a healthy 

lifestyle, may help living well with certain chronic diseases or conditions
15

Examples of Second Category

of Intended Use

• Product promotes physical activity, which, as part of a 

healthy lifestyle, may help reduce the risk of high blood 

pressure. 

• Software product tracks your caloric intake and helps you 

manage a healthy eating plan to maintain a healthy 

weight and balanced diet. Healthy weight and balanced 

diet may help living well with high blood pressure and 

type 2 diabetes. 

• Product tracks activity sleep patterns and promotes 

healthy sleep habits, which, as part of a healthy lifestyle, 

may help reduce the risk for developing type 2 diabetes. 

(Section III page 4-5)
16

Does Product Present Low Risk to

Safety of Users and Other Persons?

If the answer to any of the following questions is “YES,” the 

product is NOT a low risk general wellness product and is not 

covered by this guidance.

1. Is the product invasive? 

2. Is the product implanted? 

3. Does the product involve an intervention or technology 

that may pose a risk to the safety of users and other 

persons if regulatory controls are not applied, such as risks 

from lasers or radiation exposure?

(Section IV pg. 5)
17

Example of Products that Present Risk 

to User’s Safety and Would Not be “Low Risk”

• A laser product that claims to improve confidence in user’s 

appearance by rejuvenating the skin. 

• Although the claims of rejuvenating the skin and improving 

confidence in user’s appearance are general wellness 

claims, laser technology presents risks of skin and eye 

burns. 

(Section IV pg. 6)
18

Example of Products that Present Risk 

to User’s Safety and Would Not be “Low Risk”

• Implants promoted for enhanced sexual function.

• Implants pose risks to users such as rupture or adverse 

reaction to implant materials and risks associated with the 

implantation procedure. 
19

Examples of Low Risk General

Wellness Products

• A mobile application that solely monitors and records 

daily energy expenditure and cardiovascular workout 

activities to “allow awareness of one’s exercise activities 

to improve or maintain good cardiovascular health.” 

This claim relates to a specific organ only in the context 

of general health and does not refer to a disease or 

medical condition. Although the monitoring or recording 

of exercise activities present risks (such as inaccuracy), 

when made in the absence of disease or medical 

condition claims, the technology does not pose risks to 

the safety of users or other persons if specific regulatory 

controls are not applied. This product meets both 

factors for a low risk general wellness product.
20

Examples of Low Risk General

Wellness Products

• A mobile application that monitors and records food 

consumption to “manage dietary activity for weight 

management and alert the user, health care provider, or 

family member of unhealthy dietary activity.” 

This claim relates to dietary choices and weight 

management, and thus is a general wellness claim. The 

technology for monitoring or recording food 

consumption does not pose risk to the safety of users 

and other persons if specific regulatory controls are not 

applied. This product meets both factors for a low risk 

general wellness product. 

(Section IV pg. 6)
21

Examples of Low Risk General

Wellness Products

• A portable product that is intended to monitor the pulse 

rate of users during exercise and hiking.

This claim relates only to exercise and hiking and does not 

refer to a disease or medical condition. Thus, it is a general 

wellness claim. In addition, the technology for monitoring 

pulse rate does not pose a risk to the safety of users and 

other persons if specific regulatory controls are not applied. 

Therefore, this product meets both factors for a low risk 

general wellness product. 

(Section V pg. 7)
22

Question and Answer 

Session
Questions?

If you have questions related to specific products or claims, 

please contact:

digitalhealth@fda.hhs.gov

Any other questions, please contact:

Division of Industry and Consumer Education at 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be 

available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; Sub-heading: 

Device-Specific Topics