Document ID: FDA-2014-N-1039-0015
Agency: fda
Document Type: Notice
Title: General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2016-07-29T04:00Z

[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)]
[Notices]
[Pages 49993-49995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17902]

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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; Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``General Wellness: Policy for 
Low Risk Devices.'' The guidance is intended to provide clarity to 
industry and FDA staff on Center for Devices and Radiological Health's 
(CDRH) compliance policy for low-risk products that promote a healthy 
lifestyle (general wellness products). By clarifying the 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: They are 
intended for only general wellness use as defined in the guidance and 
present a low risk to the safety of users and other persons.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1039 for ``General Wellness: Policy for Low Risk Devices.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper

[[Page 49994]]

submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 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.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002, 301-796-5528.

SUPPLEMENTARY INFORMATION: 

I. Background

    CDRH does not intend to examine low risk general wellness products 
to determine whether they are devices within the meaning of section 
201(h) (21 U.S.C. 321(h)) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) or, if they are devices, whether they comply with the 
premarket review and postmarket regulatory requirements for devices 
under the FD&C Act and implementing regulations, 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 (MDR) requirements (21 CFR part 803).
    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 the guidance and 
(2) present a low risk to the safety of users and other persons. A 
general wellness product has an intended use that relates to 
maintaining or encouraging a general state of health or a healthy 
activity, or has 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.
    CDRH's general wellness policy applies only to general wellness 
products that are low risk. In order to be considered low risk for 
purposes of the guidance, the product must not: (1) Be invasive, (2) be 
implanted, or (3) involve an intervention or technology that may pose 
risk to the safety of users and other persons if specific regulatory 
controls are not applied, such as risks from lasers or radiation 
exposure.
    General wellness products may include exercise equipment, audio 
recordings, video games, software programs, and other products that are 
commonly, though not exclusively, available from retail establishments 
(including online retailers and distributors that offer software to be 
directly downloaded), when consistent with the factors outlined in the 
guidance.
    The FDA published in the Federal Register of January 20, 2015 (80 
FR 2712), the notice of availability for the draft guidance entitled 
``General Wellness: Policy for Low Risk Devices; Draft Guidance for 
Industry and Food and Drug Administration Staff'' and the comment 
period for the guidance closed on April 20, 2015.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on General Wellness: Policy for Low Risk 
Devices. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health 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 1300013 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This 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 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 part 801 and Sec.  809.10 (labeling) have been approved 
under OMB control number 0910-0485; the collections of information in 
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 part 803 (MDR 
requirements) have been approved under OMB control number 0910-0437.

[[Page 49995]]

    Dated: July 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17902 Filed 7-28-16; 8:45 am]
 BILLING CODE 4164-01-P