
[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2712-2714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1039]


General Wellness: Policy for Low Risk Devices; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``General Wellness: Policy 
for Low Risk Devices.'' FDA is issuing this draft guidance to provide 
clarity to industry and FDA staff on the Center for Devices and 
Radiological Health's (CDRH's) compliance policy for low risk products 
that promote a healthy lifestyle (general wellness products). This 
draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the

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final version of the guidance, submit either electronic or written 
comments on the draft guidance by April 20, 2015.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``General Wellness: Policy for Low Risk Devices'' to the Office of the 
Center Director, Guidance and Policy Development, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993-0002, 301-796-8589.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this draft guidance to provide clarity to industry 
and FDA staff on CDRH's compliance policy for low-risk products that 
promote a healthy lifestyle (general wellness products). CDRH does not 
intend to examine low-risk general wellness products, as discussed in 
this guidance, to determine whether they are devices within the meaning 
of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 321(h)), or, if they are devices, whether they comply 
with the FD&C Act's regulatory requirements for devices. This guidance 
does not apply to products regulated by other FDA Centers (e.g., drugs, 
biologics, dietary supplements, foods, or cosmetics) or to combination 
products, including those regulated by CDRH. By clarifying CDRH's 
policy on general wellness products, we hope to improve the 
predictability, consistency, and transparency on CDRH's regulation of 
these products.
    For purposes of the guidance, CDRH defines ``general wellness 
products'' as products which meet the following factors: (1) Are 
intended for only general wellness use, as defined in this guidance and 
(2) present a very low risk to users' safety. General wellness products 
can include exercise equipment, audio recordings, mobile apps, video 
games, and other products that are typically available from retail 
establishments (including online retailers and distributors that offer 
mobile apps to be directly downloaded), when consistent with the two 
factors above.
    The scope of the guidance is limited to certain products that have 
either: (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 associates the role of healthy lifestyle with helping to reduce 
the risk or impact of certain chronic diseases or conditions. For the 
first category of general wellness products, the intended use do not 
include any reference or connection to diseases or conditions and only 
relate to weight management, physical fitness, relaxation or stress 
management, mental acuity, self-esteem, sleep management, or sexual 
function. For the second category of general wellness products, the 
product is intended to promote, track, and/or encourage choice(s), 
which, as part of a healthy lifestyle, may either help to reduce the 
risk of, or help living well with, chronic diseases or conditions where 
it is well understood that the healthy lifestyle choice(s) may reduce 
the risk or impact of a chronic disease or condition.
    The general wellness policy does not extend to devices that present 
inherent risks to a user's safety. The guidance sets out factors we 
will consider to identify a device as low risk. If the product is 
invasive, involves an intervention or technology that may pose a risk 
to a user's safety if device controls are not applied (such as risks 
from lasers, radiation exposure, or implants), raises novel questions 
of usability, or raises questions of biocompatibility, then the device 
is not covered by this guidance.
    We welcome comments on all aspects of this draft guidance. We are 
particularly interested in comments regarding CDRH's proposed list of 
general wellness intended uses that relate to maintaining or 
encouraging a general state of health or a healthy activity. Please 
comment on the current list as well as other intended uses regarding 
sustaining or offering general improvement to conditions and functions 
associated with a general state of health that do not make any 
reference to diseases or conditions that CDRH should consider including 
in the list.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's proposed approach on general 
wellness products. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov. Persons unable to download an electronic 
copy of ``General Wellness: Policy for Low Risk Devices'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1830 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807 (registration and listing 
and premarket notification (510(k))) have been approved under OMB 
control numbers 0910-0625 and 0910-0120, respectively; the collections 
of information in 21 CFR part 801 and 21 CFR 809.10 (labeling) have 
been approved under OMB control number 0910-0485; the collections of 
information in 21 CFR part 820 (good manufacturing practice 
requirements as set forth in the quality system regulation) have been 
approved under OMB control number 0910-0073; and the collections of 
information in 21 CFR part 803 (medical device reporting (MDR) 
requirements) have been approved under OMB control number 0910-0437.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of

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Dockets Management (see ADDRESSES). It is only necessary to send one 
set of comments. Identify comments with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00756 Filed 1-16-15; 8:45 am]
BILLING CODE 4164-01-P


