81 FR 49993 - General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 146 (July 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 146 (July 29, 2016)
| Page Range | 49993-49995 | |
| FR Document | 2016-17902 |
[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)] [Notices] [Pages 49993-49995] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17902] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [email protected] 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
![Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices 49993
completed DFUF order) in your wire not to be used for questions related to guidance documents are welcome at any
transfer. Without the PIN, your payment other aspects of medical device user time.
may not be applied to your facility and fees.) Problems with BERS should be ADDRESSES: You may submit comments
your registration may be delayed. directed to http:// as follows:
The originating financial institution www.accessdata.fda.gov/scripts/email/
may charge a wire transfer fee. Ask your cber/bldregcontact.cfm or call 240–402– Electronic Submissions
financial institution about the fee and 8360. Submit electronic comments in the
add it to your payment to ensure that following way:
your order is fully paid. Use the D. Enter Your DFUF Order PIN and PCN • Federal eRulemaking Portal: http://
following account information when After completing your annual or www.regulations.gov. Follow the
sending a wire transfer: U.S. Dept. of initial registration and device listing, instructions for submitting comments.
Treasury, TREAS NYC, 33 Liberty St., you will be prompted to enter your Comments submitted electronically,
New York, NY 10045, Acct. No. DFUF order PIN and PCN, when including attachments, to http://
75060099, Routing No. 021030004, applicable. This process does not apply www.regulations.gov will be posted to
SWIFT: FRNYUS33, Beneficiary: FDA, to establishments engaged only in the the docket unchanged. Because your
8455 Colesville Rd., 14th Floor, Silver manufacture, preparation, propagation, comment will be made public, you are
Spring, MD 20993–0002. (If needed, compounding, or processing of licensed solely responsible for ensuring that your
FDA’s tax identification number is 53– biologic devices. CBER will send comment does not include any
0196965.) invoices for payment of the confidential information that you or a
C. Complete the Information Online To establishment registration fee to such third party may not wish to be posted,
Update Your Establishment’s Annual establishments. such as medical information, your or
Registration for FY 2017, or To Register Dated: July 25, 2016.
anyone else’s Social Security number, or
a New Establishment for FY 2017 confidential business information, such
Leslie Kux,
as a manufacturing process. Please note
Go to the Center for Devices and Associate Commissioner for Policy. that if you include your name, contact
Radiological Health’s Web site at http:// [FR Doc. 2016–17903 Filed 7–28–16; 8:45 am] information, or other information that
www.fda.gov/MedicalDevices/ BILLING CODE 4164–01–P identifies you in the body of your
DeviceRegulationandGuidance/ comments, that information will be
HowtoMarketYourDevice/Registration posted on http://www.regulations.gov.
andListing/default.htm and click the DEPARTMENT OF HEALTH AND • If you want to submit a comment
‘‘Access Electronic Registration’’ link on HUMAN SERVICES with confidential information that you
the left side of the page. This opens up do not wish to be made available to the
a new page with important information Food and Drug Administration
public, submit the comment as a
about the FDA Unified Registration and [Docket No. FDA–2014–N–1039] written/paper submission and in the
Listing System (FURLS). After reading manner detailed (see ‘‘Written/Paper
this information, click on the ‘‘Access General Wellness: Policy for Low Risk Submissions’’ and ‘‘Instructions’’).
Electronic Registration’’ link in the Devices; Guidance for Industry and
middle of the page. This link takes you Food and Drug Administration Staff; Written/Paper Submissions
to an FDA Industry Systems page with Availability Submit written/paper submissions as
tutorials that demonstrate how to create follows:
a new FURLS user account if your AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
establishment did not create an account HHS. written/paper submissions): Division of
in FY 2016. Manufacturers of licensed ACTION: Notice of availability. Dockets Management (HFA–305), Food
biologics should register in the BER and Drug Administration, 5630 Fishers
system at http://www.fda.gov/ SUMMARY: The Food and Drug
Lane, Rm. 1061, Rockville, MD 20852.
BiologicsBloodVaccines/ Administration (FDA) is announcing the • For written/paper comments
GuidanceCompliance availability of the guidance entitled submitted to the Division of Dockets
RegulatoryInformation/Establishment ‘‘General Wellness: Policy for Low Risk Management, FDA will post your
Registration/BloodEstablishment Devices.’’ The guidance is intended to comment, as well as any attachments,
Registration/default.htm. provide clarity to industry and FDA except for information submitted,
Enter your existing account ID and staff on Center for Devices and marked and identified, as confidential,
password to log into FURLS. From the Radiological Health’s (CDRH) if submitted as detailed in
FURLS/FDA Industry Systems menu, compliance policy for low-risk products ‘‘Instructions.’’
click on the Device Registration and that promote a healthy lifestyle (general Instructions: All submissions received
Listing Module (DRLM) of FURLS wellness products). By clarifying the must include the Docket No. FDA–
button. New establishments will need to policy on general wellness products, we 2014–N–1039 for ‘‘General Wellness:
register and existing establishments will hope to improve the predictability, Policy for Low Risk Devices.’’ Received
update their annual registration using consistency, and transparency on comments will be placed in the docket
choices on the DRLM menu. When you CDRH’s regulation of these products. and, except for those submitted as
choose to register or update your annual For purposes of the guidance, CDRH ‘‘Confidential Submissions,’’ publicly
registration, the system will prompt you defines ‘‘general wellness products’’ as viewable at http://www.regulations.gov
through the entry of information about products which meet the following or at the Division of Dockets
ebenthall on DSK5MVXVN1PROD with NOTICES
your establishment and your devices. If factors: They are intended for only Management between 9 a.m. and 4 p.m.,
you have any problems with this general wellness use as defined in the Monday through Friday.
process, email: reglist@cdrh.fda.gov or guidance and present a low risk to the • Confidential Submissions—To
call 301–796–7400 for assistance. (Note: safety of users and other persons. submit a comment with confidential
This email address and this telephone DATES: Submit either electronic or information that you do not wish to be
number are for assistance with written comments on this guidance at made publicly available, submit your
establishment registration only; they are any time. General comments on Agency comments only as a written/paper
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![Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices 49995
Dated: July 25, 2016. as to eligibility for, and amount of, submit written information relevant to
Leslie Kux, compensation. the issues described above in the case of
Associate Commissioner for Policy. A petition may be filed with respect the petitions listed below. Any person
[FR Doc. 2016–17902 Filed 7–28–16; 8:45 am] to injuries, disabilities, illnesses, choosing to do so should file an original
BILLING CODE 4164–01–P
conditions, and deaths resulting from and three (3) copies of the information
vaccines described in the Vaccine Injury with the Clerk of the U.S. Court of
Table (the Table) set forth at 42 CFR Federal Claims at the address listed
DEPARTMENT OF HEALTH AND 100.3. This Table lists for each covered above (under the heading ‘‘For Further
HUMAN SERVICES childhood vaccine the conditions that Information Contact’’), with a copy to
may lead to compensation and, for each HRSA addressed to Director, Division of
Health Resources and Services condition, the time period for Injury Compensation Programs,
Administration occurrence of the first symptom or Healthcare Systems Bureau, 5600
manifestation of onset or of significant Fishers Lane, 08N146B, Rockville, MD
National Vaccine Injury Compensation aggravation after vaccine 20857. The Court’s caption (Petitioner’s
Program; List of Petitions Received administration. Compensation may also Name v. Secretary of Health and Human
AGENCY: Health Resources and Services be awarded for conditions not listed in Services) and the docket number
Administration, HHS. the Table and for conditions that are assigned to the petition should be used
manifested outside the time periods as the caption for the written
ACTION: Notice.
specified in the Table, but only if the submission. Chapter 35 of title 44,
SUMMARY: The Health Resources and petitioner shows that the condition was United States Code, related to
Services Administration (HRSA) is caused by one of the listed vaccines. paperwork reduction, does not apply to
publishing this notice of petitions Section 2112(b)(2) of the PHS Act, 42 information required for purposes of
received under the National Vaccine U.S.C. 300aa-12(b)(2), requires that carrying out the Program.
Injury Compensation Program (the ‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed Dated: July 22, 2016.
Program), as required by Section James Macrae,
2112(b)(2) of the Public Health Service under section 2111 the Secretary shall
publish notice of such petition in the Acting Administrator.
(PHS) Act, as amended. While the
Secretary of Health and Human Services Federal Register.’’ Set forth below is a List of Petitions Filed
is named as the respondent in all list of petitions received by HRSA on
June 1, 2016, through June 30, 2016. 1. Ruby Lorenzo, Phoenix, Arizona, Court of
proceedings brought by the filing of Federal Claims No: 16–0647V.
petitions for compensation under the This list provides the name of 2. Jacqueline Berg on behalf of Marilyn Moss,
Program, the United States Court of petitioner, city and state of vaccination Deceased, Wellesley Hills,
Federal Claims is charged by statute (if unknown then city and state of Massachusetts, Court of Federal Claims
with responsibility for considering and person or attorney filing claim), and No: 16–0650V.
acting upon the petitions. case number. In cases where the Court 3. Sarah Etheridge-Criswell, Van Nuys,
has redacted the name of a petitioner California, Court of Federal Claims No:
FOR FURTHER INFORMATION CONTACT: For 16–0652V.
information about requirements for and/or the case number, the list reflects
4. Lisa Picker, St. Louis, Missouri, Court of
filing petitions, and the Program in such redaction. Federal Claims No: 16–0654V.
Section 2112(b)(2) also provides that 5. Joann Brenner, Huntington Valley,
general, contact the Clerk, United States
the special master ‘‘shall afford all Pennsylvania, Court of Federal Claims
Court of Federal Claims, 717 Madison
interested persons an opportunity to No: 16–0656V.
Place NW., Washington, DC 20005,
submit relevant, written information’’ 6. Talat Pervez, Long Island City, New York,
(202) 357–6400. For information on Court of Federal Claims No: 16–0657V.
relating to the following:
HRSA’s role in the Program, contact the 1. The existence of evidence ‘‘that 7. Gayle E. Gagne, Greenwood, Indiana, Court
Director, National Vaccine Injury there is not a preponderance of the of Federal Claims No: 16–0660V.
Compensation Program, 5600 Fishers evidence that the illness, disability, 8. Linda Ybarra, Dallas, Texas, Court of
Lane, Room 08N146B, Rockville, MD injury, condition, or death described in
Federal Claims No: 16–0661V.
20857; (301) 443–6593, or visit our Web 9. Stephen Capozzoli, Smithtown, New York,
the petition is due to factors unrelated Court of Federal Claims No: 16–0666V.
site at: http://www.hrsa.gov/ to the administration of the vaccine 10. Margaret Elledge, Carlsbad, California,
vaccinecompensation/index.html. described in the petition,’’ and Court of Federal Claims No: 16–0667V.
SUPPLEMENTARY INFORMATION: The 2. Any allegation in a petition that the 11. Nicholas Edwards, Fort Worth, Texas,
Program provides a system of no-fault petitioner either: Court of Federal Claims No: 16–0668V.
compensation for certain individuals a. ‘‘[S]ustained, or had significantly 12. Christi Jewell, Jefferson, Ohio, Court of
who have been injured by specified aggravated, any illness, disability, Federal Claims No: 16–0670V.
childhood vaccines. Subtitle 2 of Title injury, or condition not set forth in the 13. Luis C. Ramos, North Kansas City,
XXI of the PHS Act, 42 U.S.C. 300aa-10 Missouri, Court of Federal Claims No:
Vaccine Injury Table but which was 16–0673V.
et seq., provides that those seeking caused by’’ one of the vaccines referred 14. Gregory Thompson, Philadelphia,
compensation are to file a petition with to in the Table, or Pennsylvania, Court of Federal Claims
the U.S. Court of Federal Claims and to b. ‘‘[S]ustained, or had significantly No: 16–0675V.
serve a copy of the petition on the aggravated, any illness, disability, 15. Fonda Bravo, Asheville, North Carolina,
Secretary of Health and Human injury, or condition set forth in the Court of Federal Claims No: 16–0679V.
Services, who is named as the Vaccine Injury Table the first symptom 16. Virginia A. Calfee, Christiansburg,
ebenthall on DSK5MVXVN1PROD with NOTICES
respondent in each proceeding. The or manifestation of the onset or Virginia, Court of Federal Claims No: 16–
Secretary has delegated this 0680V.
significant aggravation of which did not
17. Candy F. Hall, Linwood, New Jersey,
responsibility under the Program to occur within the time period set forth in Court of Federal Claims No: 16–0681V.
HRSA. The Court is directed by statute the Table but which was caused by a 18. Hamid Ahmed, Dallas, Texas, Court of
to appoint special masters who take vaccine’’ referred to in the Table. Federal Claims No: 16–0684V.
evidence, conduct hearings as In accordance with Section 19. Marietta Schenck, Sarasota, Florida,
appropriate, and make initial decisions 2112(b)(2), all interested persons may Court of Federal Claims No: 16–0685V.
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Document Created: 2018-02-08 07:51:23
Document Modified: 2018-02-08 07:51:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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. | |
| FR Citation | 81 FR 49993 |
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