80 FR 21743 - Pilot Program for Center for Devices and Radiological Health Electronic Submission for Home Use Device Labeling
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 75 (April 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 75 (April 20, 2015)
| Page Range | 21743-21744 | |
| FR Document | 2015-08957 |
[Federal Register Volume 80, Number 75 (Monday, April 20, 2015)] [Notices] [Pages 21743-21744] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08957] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1037] Pilot Program for Center for Devices and Radiological Health Electronic Submission for Home Use Device Labeling AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing the availability of a CDRH electronic submissions Pilot Program database to house labeling for home use devices. Participation in the pilot is open to applicants who label their device(s) for home use. Participation in the pilot project is voluntary. Participants will be asked to navigate through the electronic submissions system and practice submitting labels and package inserts. The pilot project is intended to provide industry and CDRH staff the opportunity to evaluate the submissions process and system and to receive comments from industry participants. DATES: FDA will accept applications for participation in the voluntary electronic submissions CDRH Home Use Device Labeling Pilot Program from May 1, 2015, through May 31, 2015. See the ``Participation'' section for instructions on how to submit a request to participate. The pilot project will occur July 1, 2015, through December 31, 2015. FOR FURTHER INFORMATION CONTACT: Mary Weick-Brady, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66 Rm. 5426, Silver Spring MD 20993, 301-796- 6089, [email protected]. SUPPLEMENTARY INFORMATION: I. Background CDRH is responsible for ensuring that medical devices are safe and effective when used for their intended purpose. Risks are inherent in all CDRH-regulated medical devices, and the Center plays a critical role in preventing injuries and deaths related to product use. CDRH minimizes risk through regulation, enforcement, and education. Risk minimization is accomplished, in part, through clear communication on the benefits and risks of the medical devices regulated by the Center, including communications by CDRH, product manufacturers, and product distributors. These communications include medical device labeling produced by manufacturers and distributors. Medical device labeling provides safety information, instructions for use, and/or other necessary information to the user. This labeling can be essential for home-use devices, which are much more likely to be used by lay users, who frequently have not been trained to use such medical devices and who are especially reliant on the instructions for use and other information provided by the device label and package insert. When used in an environment where a healthcare professional is not available to provide supervision and assistance, these devices can present unique concerns and challenges. When a home-use device is used over a period of years, it becomes increasingly more likely that it may be separated from its original labeling or that its original labeling will not include current safety information or instructions for use. In contrast with use in professional healthcare settings, a patient or caregiver using a home-use device in a setting without professional oversight may not have extensive experience in the use of a device and may not have ready access to the original packaging or to alternative sources of information about a device. Home-use devices have significant public health importance to patients, caregivers, and healthcare professionals. Therefore, it is necessary to ensure that users are able to access necessary information for use, including safety information and instructions for use. Although many manufacturers have Internet sites that provide information concerning the devices they currently market, those sites typically focus on newer products and often do not provide any information on devices that they no longer actively market. Web sites also vary considerably in the types of information provided and may lack important details concerning their devices. Although some manufacturers' [[Page 21744]] Web sites provide some labeling, FDA believes that most do not provide the label and package insert for all of their home-use devices listed with FDA. II. CDRH Home Use Device Labeling Pilot CDRH is developing an electronic submissions database, accessible to the public through FDA's Web site, of labels and package inserts for listed home-use devices. This database would fill an important gap in the information available to patients, caregivers, and the healthcare community concerning home-use devices. The database would allow both broad searches to identify legally marketed home-use devices that may fill a particular need and focused searches to obtain information concerning the use of a specific home-use device. This electronic submissions database will be evaluated for usability through the CDRH Home Use Device Labeling Pilot Project. This pilot project will proceed for 6 months. Participation in the pilot is open to applicants who label their device(s) for home use. Participants will be asked to navigate through the electronic submissions system and practice submitting labels and package inserts. The pilot project is intended to provide industry and CDRH staff the opportunity to evaluate the submissions process and system and to receive comments from industry participants. Comments received during the pilot project will be used to evaluate the usability of the database. FDA will not review the content of any labeling submitted to the pilot database for a regulatory purpose. The submitted labeling and the database will only be available to pilot participants. A. Participation Volunteers interested in participating in the pilot project should contact pilot staff by email at [email protected]. The following information should be included in the request: Contact name, contact phone number, and contact email address. FDA will contact interested applicants to discuss the pilot project. FDA is seeking a limited number of participants (no more than nine) to participate in this pilot project. B. Procedures By following a series of prompts and instructions, pilot participants will submit a PDF version of their device labeling to the pilot database. The content of the submissions will not be reviewed by FDA for any regulatory purpose, nor will the pilot database be available to the public during this pilot project. During the pilot, CDRH staff will be available to answer any questions or concerns that may arise. Pilot project participants will be asked to comment on and discuss their experiences with the pilot submissions process. Their comments and discussions will assist CDRH in its development of this electronic submissions database. III. Duration of the Home Use Device Labeling Pilot FDA intends to accept requests for participation in the Home Use Device Labeling Pilot from May 1, 2015, through May 31, 2015. The pilot will proceed for 6 months, from July 1, 2015, through December 31, 2015. This pilot program may be extended as resources and needs allow. IV. Paperwork Reduction Act of 1995 This notice 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 parts 801 and 809 have been approved under OMB control number 0910-0485. V. Comments Interested persons may submit electronic comments regarding the Home Use Device Labeling Pilot to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: April 14, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-08957 Filed 4-17-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices 21743
by expert panels to be of high quality Register by using the article search I. Background
and to advance the field. feature at: www.federalregister.gov. CDRH is responsible for ensuring that
• The average number of publications Specifically, through the advanced medical devices are safe and effective
per award based on NIDILRR-funded search feature at this site, you can limit when used for their intended purpose.
research and development activities in your search to documents published by Risks are inherent in all CDRH-regulated
refereed journals. the Department. medical devices, and the Center plays a
• The percentage of new NIDILRR
Dated: April 14, 2015. critical role in preventing injuries and
grants that assess the effectiveness of
John Tschida, deaths related to product use. CDRH
interventions, programs, and devices
using rigorous methods. Director, National Institute on Disability, minimizes risk through regulation,
NIDILRR uses information submitted Independent Living, and Rehabilitation enforcement, and education. Risk
by grantees as part of their Annual Research. minimization is accomplished, in part,
Performance Reports for these reviews. [FR Doc. 2015–09013 Filed 4–17–15; 8:45 am] through clear communication on the
5. Continuation Awards: In making a BILLING CODE 4154–01–P benefits and risks of the medical devices
continuation award, the Administrator regulated by the Center, including
of the Administration for Community communications by CDRH, product
Living may consider, under 45 CFR part DEPARTMENT OF HEALTH AND manufacturers, and product distributors.
75, the extent to which a grantee has HUMAN SERVICES These communications include medical
made ‘‘substantial progress toward device labeling produced by
meeting the objectives in its approved Food and Drug Administration manufacturers and distributors.
application.’’ This consideration Medical device labeling provides
[Docket No. FDA–2015–N–1037] safety information, instructions for use,
includes the review of a grantee’s
progress in meeting the targets and and/or other necessary information to
Pilot Program for Center for Devices the user. This labeling can be essential
projected outcomes in its approved and Radiological Health Electronic
application, and whether the grantee for home-use devices, which are much
Submission for Home Use Device more likely to be used by lay users, who
has expended funds in a manner that is Labeling
consistent with its approved application frequently have not been trained to use
and budget. In making a continuation AGENCY: Food and Drug Administration, such medical devices and who are
grant, the Administrator also considers HHS. especially reliant on the instructions for
whether the grantee is operating in ACTION: Notice. use and other information provided by
compliance with the assurances in its the device label and package insert.
approved application, including those SUMMARY: The Food and Drug When used in an environment where a
applicable to Federal civil rights laws Administration (FDA) Center for healthcare professional is not available
that prohibit discrimination in programs Devices and Radiological Health (CDRH) to provide supervision and assistance,
or activities receiving Federal financial is announcing the availability of a these devices can present unique
assistance from the Department. CDRH electronic submissions Pilot concerns and challenges. When a home-
Continuation funding is also subject to Program database to house labeling for use device is used over a period of
availability of funds. home use devices. Participation in the years, it becomes increasingly more
pilot is open to applicants who label likely that it may be separated from its
VII. Agency Contact their device(s) for home use. original labeling or that its original
FOR FURTHER INFORMATION CONTACT: Participation in the pilot project is labeling will not include current safety
Patricia Barrett, U.S. Department of voluntary. Participants will be asked to information or instructions for use. In
Health and Human Services, 400 navigate through the electronic contrast with use in professional
Maryland Avenue SW., room 5142, PCP, submissions system and practice healthcare settings, a patient or
Washington, DC 20202–2700. submitting labels and package inserts. caregiver using a home-use device in a
Telephone: (202) 245–6211 or by email: The pilot project is intended to provide setting without professional oversight
patricia.barrett@acl.hhs.gov. industry and CDRH staff the may not have extensive experience in
If you use a TDD or a TTY, call the opportunity to evaluate the submissions the use of a device and may not have
Federal Relay Service (FRS), toll free, at process and system and to receive ready access to the original packaging or
1–800–877–8339. comments from industry participants. to alternative sources of information
DATES: FDA will accept applications for about a device.
VIII. Other Information Home-use devices have significant
participation in the voluntary electronic
Electronic Access to This Document: submissions CDRH Home Use Device public health importance to patients,
The official version of this document is Labeling Pilot Program from May 1, caregivers, and healthcare professionals.
the document published in the Federal 2015, through May 31, 2015. See the Therefore, it is necessary to ensure that
Register. Free Internet access to the ‘‘Participation’’ section for instructions users are able to access necessary
official edition of the Federal Register on how to submit a request to information for use, including safety
and the Code of Federal Regulations is participate. The pilot project will occur information and instructions for use.
available via the Federal Digital System July 1, 2015, through December 31, Although many manufacturers have
at: www.gpo.gov/fdsys. At this site you 2015. Internet sites that provide information
can view this document, as well as all concerning the devices they currently
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with NOTICES
other documents of this Department market, those sites typically focus on
published in the Federal Register, in Mary Weick-Brady, Center for Devices newer products and often do not
text or Adobe Portable Document and Radiological Health, Food and Drug provide any information on devices that
Format (PDF). To use PDF you must Administration, 10903 New Hampshire they no longer actively market. Web
have Adobe Acrobat Reader, which is Ave., Bldg. 66 Rm. 5426, Silver Spring sites also vary considerably in the types
available free at the site. MD 20993, 301–796–6089, Mary.Brady@ of information provided and may lack
You may also access documents of the fda.hhs.gov. important details concerning their
Department published in the Federal SUPPLEMENTARY INFORMATION: devices. Although some manufacturers’
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![21744 Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices
Web sites provide some labeling, FDA project. During the pilot, CDRH staff DEPARTMENT OF HEALTH AND
believes that most do not provide the will be available to answer any HUMAN SERVICES
label and package insert for all of their questions or concerns that may arise.
home-use devices listed with FDA. Pilot project participants will be asked Office of the Secretary
II. CDRH Home Use Device Labeling to comment on and discuss their [Document Identifier: HHS–OS–0990–0392–
Pilot experiences with the pilot submissions 30–D]
process. Their comments and
CDRH is developing an electronic Agency Information Collection
discussions will assist CDRH in its
submissions database, accessible to the Activities; Submission to OMB for
public through FDA’s Web site, of labels development of this electronic
submissions database. Review and Approval; Public Comment
and package inserts for listed home-use Request
devices. This database would fill an III. Duration of the Home Use Device
important gap in the information Labeling Pilot AGENCY: Office of the Secretary, HHS.
available to patients, caregivers, and the ACTION: Notice.
healthcare community concerning FDA intends to accept requests for
home-use devices. The database would participation in the Home Use Device SUMMARY: In compliance with section
allow both broad searches to identify Labeling Pilot from May 1, 2015, 3507(a)(1)(D) of the Paperwork
legally marketed home-use devices that through May 31, 2015. The pilot will Reduction Act of 1995, the Office of the
may fill a particular need and focused proceed for 6 months, from July 1, 2015, Secretary (OS), Department of Health
searches to obtain information through December 31, 2015. This pilot and Human Services, has submitted an
concerning the use of a specific home- program may be extended as resources Information Collection Request (ICR),
use device. described below, to the Office of
and needs allow.
This electronic submissions database Management and Budget (OMB) for
will be evaluated for usability through IV. Paperwork Reduction Act of 1995 review and approval. The ICR is for
the CDRH Home Use Device Labeling renewal of the approved information
Pilot Project. This pilot project will This notice refers to previously collection assigned OMB control
proceed for 6 months. Participation in approved collections of information number 0990–0392, scheduled to expire
the pilot is open to applicants who label found in FDA regulations. These on May 31, 2015. Comments submitted
their device(s) for home use. collections of information are subject to during the first public review of this ICR
Participants will be asked to navigate review by the Office of Management and will be provided to OMB. OMB will
through the electronic submissions Budget (OMB) under the Paperwork accept further comments from the
system and practice submitting labels Reduction Act of 1995 (44 U.S.C. 3501– public on this ICR during the review
and package inserts. The pilot project is 3520). The collections of information in and approval period.
intended to provide industry and CDRH 21 CFR parts 801 and 809 have been DATES: Comments on the ICR must be
staff the opportunity to evaluate the approved under OMB control number received on or before May 20, 2015.
submissions process and system and to 0910–0485. ADDRESSES: Submit your comments to
receive comments from industry OIRA_submission@omb.eop.gov or via
participants. Comments received during V. Comments
facsimile to (202) 395–5806.
the pilot project will be used to evaluate Interested persons may submit FOR FURTHER INFORMATION CONTACT:
the usability of the database. FDA will electronic comments regarding the Information Collection Clearance staff,
not review the content of any labeling
Home Use Device Labeling Pilot to Information.CollectionClearance@
submitted to the pilot database for a
http://www.regulations.gov or written hhs.gov or (202) 690–6162.
regulatory purpose. The submitted
labeling and the database will only be comments to the Division of Dockets SUPPLEMENTARY INFORMATION: When
available to pilot participants. Management (HFA–305), Food and Drug submitting comments or requesting
Administration, 5630 Fishers Lane, Rm. information, please include the OMB
A. Participation 1061, Rockville, MD 20852. It is only control number 0990–0392 and
Volunteers interested in participating necessary to send one set of comments. document identifier HHS–OS0990–
in the pilot project should contact pilot Identify comments with the docket 0392–30D for reference.
staff by email at Mary.Brady@ number found in brackets in the Information Collection Request Title:
fda.hhs.gov. The following information heading of this document. Received Office of Adolescent Health and
should be included in the request: comments may be seen in the Division Administration for Children, Youth and
Contact name, contact phone number, of Dockets Management between 9 a.m. Families Teen Pregnancy Prevention
and contact email address. FDA will and 4 p.m., Monday through Friday and Performance Measure Collection.
contact interested applicants to discuss will be posted to the docket at http:// Abstract: The Office of Adolescent
the pilot project. FDA is seeking a www.regulations.gov. Health (OAH), U.S. Department of
limited number of participants (no more Health and Human Services (HHS) is
than nine) to participate in this pilot Dated: April 14, 2015. requesting an extension without change
project. Leslie Kux, of a currently approved information
Associate Commissioner for Policy. collection request by OMB. The purpose
B. Procedures of the extension is to complete the
[FR Doc. 2015–08957 Filed 4–17–15; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
By following a series of prompts and BILLING CODE 4164–01–P
ongoing data collection for the Office of
instructions, pilot participants will Adolescent Health and Administration
submit a PDF version of their device for Children, Youth and Families Teen
labeling to the pilot database. The Pregnancy Prevention Performance
content of the submissions will not be Measures.
reviewed by FDA for any regulatory Need and Proposed Use of the
purpose, nor will the pilot database be Information: To collect performance
available to the public during this pilot measure data on the OAH Teen
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Document Created: 2018-02-21 10:12:45
Document Modified: 2018-02-21 10:12:45
| 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. | |
| Dates | FDA will accept applications for participation in the voluntary electronic submissions CDRH Home Use Device Labeling Pilot Program from May 1, 2015, through May 31, 2015. See the ``Participation'' section for instructions on how to submit a request to participate. The pilot project will occur July 1, 2015, through December 31, 2015. | |
| Contact | Mary Weick-Brady, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66 Rm. 5426, Silver Spring MD 20993, 301-796- 6089, [email protected] | |
| FR Citation | 80 FR 21743 |
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