[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2712-2714]
From the Federal Register Online via the Government Publishing 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General Wellness: Policy for Low Risk Devices; Draft Guidance for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availability of the draft guidance entitled ``General Wellness: Policy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 FDA is issuing this draft guidance to provide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draft guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the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comments on the draft guidance by April 20, 2015.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requests for a single hard copy of the draft guidance document entitled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Submit electronic comments on the draft guidance to http://www.regulations.gov.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 [email protected] 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]
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