82 FR 37456 - Qualification of Medical Device Development Tools; Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 153 (August 10, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 153 (August 10, 2017)
| Page Range | 37456-37458 | |
| FR Document | 2017-16827 |
[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)] [Notices] [Pages 37456-37458] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16827] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Qualification of Medical Device Development Tools; Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Qualification of Medical Device Development Tools (MDDT).'' This document formalizes the MDDT program and provides guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a new voluntary process within the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device development and evaluation programs. In addition, the guidance discusses the framework of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. FDA considered comments on the draft guidance and revised the guidance as appropriate. 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: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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.'' [[Page 37457]] Instructions: All submissions received must include the Docket No. FDA-2013-D-1279 for ``Qualification of Medical Device Development Tools.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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 ``Qualification of Medical Device Development Tools'' 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: Kathryn O'Callaghan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5418, Silver Spring, MD 20993-0002, (301) 796-6349. SUPPLEMENTARY INFORMATION: I. Background MDDT is a scientifically validated tool that aids device development and regulatory evaluation. The guidance describes the framework and process for the voluntary CDRH qualification of MDDT, including definitions of applicable terms, criteria for evaluating a MDDT for a specific context of use, the threshold for qualification, and the contents of a qualification submission. The intent of this voluntary qualification policy is to: (1) Enable faster, more efficient development of important life-saving and health promoting medical devices, (2) promote the development of tools to facilitate more timely device evaluation, (3) provide a mechanism to better leverage advances in regulatory science, and (4) more quickly and more clearly communicate with CDRH stakeholders about important advances in regulatory science that may be leveraged to speed device development and regulatory evaluation. CDRH expects the qualification process to expedite development of publicly available tools, which could potentially be used widely in multiple device development programs. The intent of this voluntary MDDT program is to promote the development and use of tools to streamline device development and evaluation. Once an MDDT is submitted in accordance with the FDA guidance entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' (Ref. 1) and qualified for a specific context of use, it can be used by any medical device sponsor for that context of use. MDDTs can be used for the qualified context of use without the need to reconfirm the suitability and utility of the MDDT when used in a premarket submission. Qualification may contribute to acceptance and application of MDDTs across multiple medical device development programs. Qualified MDDTs can be utilized by many sponsors to aid in optimizing device development and evaluation. As discussed in the November 14, 2013, Federal Register notice (78 FR 68459), FDA announced the availability of the draft of this guidance and interested persons were invited to comment by February 12, 2014. In the August 15, 2014, Federal Register notice (79 FR 48170), FDA began accepting nominations for participation in the voluntary MDDT Pilot Program. FDA reviewed and considered all public comments received and revised this guidance as appropriate. 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 ``Qualification of Medical Device Development Tools.'' 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. This guidance is not subject to Executive Order 12866. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``Qualification of Medical Device Development Tools'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1882 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance contains information collection that is 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 under the guidance entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. [[Page 37458]] V. Reference The following reference is on display in the Dockets Management Staff (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA Guidance, ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.'' Available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf. Dated: August 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-16827 Filed 8-9-17; 8:45 am] BILLING CODE 4164-01-P
![37456 Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Average
Annual Number of
Total number burden Annual burden
Instrument number of responses per
of respondents hours per hours
respondents respondent response
Follow-up classroom observation protocol (teacher bur-
den) .................................................................................. 543 181 2 0.30 109
Follow-up protocol for child assessments in Impact Eval-
uation only (child burden) ................................................. 1980 660 1 1 660
Fidelity of Implementation Instruments for Pilot Study and Process Study
Coach Log ............................................................................ 117 39 55 0.25 536
Teacher/assistant teacher Log ............................................ 1086 362 36 0.25 3258
Implementation fidelity observation protocol (teacher bur-
den) .................................................................................. 72 24 1 0.30 7
Interview/Focus group protocol (administrator, teacher/as-
sistant teacher and coach burden) .................................. 322 107 1 1.5 161
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Electronic Submissions
Hours: 7,289. HUMAN SERVICES Submit electronic comments in the
In compliance with the requirements following way:
Food and Drug Administration
of Section 3506(c)(2)(A) of the • Federal eRulemaking Portal:
Paperwork Reduction Act of 1995, the [Docket No. FDA–2013–D–1279] https://www.regulations.gov. Follow the
Administration for Children and instructions for submitting comments.
Families is soliciting public comment Qualification of Medical Device
Comments submitted electronically,
on the specific aspects of the Development Tools; Guidance for
including attachments, to https://
Industry, Tool Developers, and Food
information collection described above. www.regulations.gov will be posted to
and Drug Administration Staff;
Copies of the proposed collection of the docket unchanged. Because your
Availability
information can be obtained and comment will be made public, you are
comments may be forwarded by writing AGENCY: Food and Drug Administration, solely responsible for ensuring that your
to the Administration for Children and HHS. comment does not include any
Families, Office of Planning, Research, ACTION: Notice. confidential information that you or a
and Evaluation, 330 C Street SW., third party may not wish to be posted,
Washington, DC 20201, Attn: OPRE SUMMARY: The Food and Drug such as medical information, your or
Reports Clearance Officer. Email Administration (FDA or Agency) is anyone else’s Social Security number, or
address: OPREinfocollection@ announcing the availability of the confidential business information, such
guidance entitled ‘‘Qualification of as a manufacturing process. Please note
acf.hhs.gov. All requests should be
Medical Device Development Tools that if you include your name, contact
identified by the title of the information
(MDDT).’’ This document formalizes the information, or other information that
collection.
MDDT program and provides guidance identifies you in the body of your
The Department specifically requests to FDA staff, industry, healthcare comments, that information will be
comments on (a) whether the proposed providers, researchers, and patient and posted on https://www.regulations.gov.
collection of information is necessary consumer groups on a new voluntary • If you want to submit a comment
for the proper performance of the process within the Center for Devices with confidential information that you
functions of the agency, including and Radiological Health (CDRH) for do not wish to be made available to the
whether the information shall have qualification of medical device public, submit the comment as a
practical utility; (b) the accuracy of the development tools (MDDT) for use in written/paper submission and in the
agency’s estimate of the burden of the device development and evaluation manner detailed (see ‘‘Written/Paper
proposed collection of information; (c) programs. In addition, the guidance Submissions’’ and ‘‘Instructions’’).
the quality, utility, and clarity of the discusses the framework of an MDDT,
including definitions of applicable Written/Paper Submissions
information to be collected; and (d)
ways to minimize the burden of the terms, criteria for evaluating an MDDT Submit written/paper submissions as
collection of information on for a specific context of use, follows:
respondents, including through the use considerations for qualification, and the • Mail/Hand delivery/Courier (for
of automated collection techniques or contents of a qualification package. FDA written/paper submissions): Dockets
considered comments on the draft Management Staff (HFA–305), Food and
other forms of information technology.
guidance and revised the guidance as Drug Administration, 5630 Fishers
Consideration will be given to
appropriate. Lane, Rm. 1061, Rockville, MD 20852.
comments and suggestions submitted
mstockstill on DSK30JT082PROD with NOTICES
within 60 days of this publication. DATES: Submit either electronic or • For written/paper comments
written comments on this guidance at submitted to the Dockets Management
Mary Jones, any time. General comments on Agency Staff, FDA will post your comment, as
ACF/OPRE Certifying Officer. guidance documents are welcome at any well as any attachments, except for
[FR Doc. 2017–16854 Filed 8–9–17; 8:45 am] time. information submitted, marked and
BILLING CODE 4184–23–P ADDRESSES: You may submit comments identified, as confidential, if submitted
as follows: as detailed in ‘‘Instructions.’’
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![37458 Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices
V. Reference AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
The following reference is on display ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
in the Dockets Management Staff (see FDA is establishing a docket for • For written/paper comments
public comment on this meeting. The submitted to the Dockets Management
ADDRESSES) and is available for viewing
docket number is FDA–2017–N–1957. Staff, FDA will post your comment, as
by interested persons between 9 a.m.
The docket will close on September 7, well as any attachments, except for
and 4 p.m., Monday through Friday; it
2017. Submit either electronic or information submitted, marked and
is also available electronically at https://
written comments on this public identified, as confidential, if submitted
www.regulations.gov. FDA has verified
meeting by September 7, 2017. as detailed in ‘‘Instructions.’’
the Web site address, as of the date this Instructions: All submissions received
document publishes in the Federal Comments received on or before
August 24, 2017, will be provided to the must include the Docket No. FDA–
Register, but Web sites are subject to 2017–N–1957 for ‘‘Medical Imaging
change over time. committee. Comments received after
that date will be taken into Drugs Advisory Committee; Notice of
1. FDA Guidance, ‘‘Requests for Feedback on Meeting; Establishment of a Public
consideration by the Agency.
Medical Device Submissions: The Pre- Docket; Request for Comments.’’
Submission Program and Meetings with You may submit comments as
follows. Please note that late, untimely Received comments, those filed in a
Food and Drug Administration Staff.’’ timely manner (see ADDRESSES), will be
Available at https://www.fda.gov/ filed comments will not be considered.
placed in the docket and, except for
downloads/MedicalDevices/ Electronic comments must be submitted
DeviceRegulationandGuidance/ those submitted as ‘‘Confidential
on or before September 7, 2017. The
GuidanceDocuments/UCM311176.pdf. Submissions,’’ publicly viewable at
https://www.regulations.gov electronic
https://www.regulations.gov or at the
Dated: August 4, 2017. filing system will accept comments
Dockets Management Staff between 9
Leslie Kux, until midnight Eastern Time at the end
a.m. and 4 p.m., Monday through
Associate Commissioner for Policy. of September 7, 2017. Comments
Friday.
[FR Doc. 2017–16827 Filed 8–9–17; 8:45 am]
received by mail/hand delivery/courier • Confidential Submissions—To
(for written/paper submissions) will be submit a comment with confidential
BILLING CODE 4164–01–P
considered timely if they are information that you do not wish to be
postmarked or the delivery service made publicly available, submit your
DEPARTMENT OF HEALTH AND acceptance receipt is on or before that comments only as a written/paper
HUMAN SERVICES date. submission. You should submit two
Electronic Submissions copies total. One copy will include the
Food and Drug Administration information you claim to be confidential
Submit electronic comments in the with a heading or cover note that states
[Docket No. FDA–2017–N–1957] following way: ‘‘THIS DOCUMENT CONTAINS
Medical Imaging Drugs Advisory • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Committee; Notice of Meeting; https://www.regulations.gov. Follow the Agency will review this copy, including
Establishment of a Public Docket; instructions for submitting comments. the claimed confidential information, in
Request for Comments Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
AGENCY: Food and Drug Administration, www.regulations.gov will be posted to claimed confidential information
HHS. the docket unchanged. Because your redacted/blacked out, will be available
ACTION: Notice; establishment of a comment will be made public, you are for public viewing and posted on
public docket; request for comments. solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
SUMMARY: The Food and Drug confidential information that you or a Staff. If you do not wish your name and
Administration (FDA or the Agency) third party may not wish to be posted, contact information to be made publicly
announces a forthcoming public such as medical information, your or available, you can provide this
advisory committee meeting of the anyone else’s Social Security number, or information on the cover sheet and not
Medical Imaging Drugs Advisory confidential business information, such in the body of your comments and you
Committee. The general function of the as a manufacturing process. Please note must identify this information as
committee is to provide advice and that if you include your name, contact ‘‘confidential.’’ Any information marked
recommendations to the Agency on information, or other information that as ‘‘confidential’’ will not be disclosed
FDA’s regulatory issues. The meeting identifies you in the body of your except in accordance with 21 CFR 10.20
will be open to the public. FDA is comments, that information will be and other applicable disclosure law. For
establishing a docket for public posted on https://www.regulations.gov. more information about FDA’s posting
comment on this document. • If you want to submit a comment of comments to public dockets, see 80
DATES: The public meeting will be held with confidential information that you FR 56469, September 18, 2015, or access
on September 8, 2017, from 8 a.m. to 4 do not wish to be made available to the the information at: https://www.gpo.gov/
p.m. public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
ADDRESSES: FDA White Oak Campus, written/paper submission and in the 23389.pdf.
10903 New Hampshire Ave., Bldg. 31 manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’). read background documents or the
mstockstill on DSK30JT082PROD with NOTICES
1503), Silver Spring, MD 20993–0002. electronic and written/paper comments
Written/Paper Submissions
Answers to commonly asked questions received, go to https://
including information regarding special Submit written/paper submissions as www.regulations.gov and insert the
accommodations due to a disability, follows: docket number, found in brackets in the
visitor parking, and transportation may • Mail/Hand delivery/Courier (for heading of this document, into the
be accessed at: https://www.fda.gov/ written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
AdvisoryCommittees/ Management Staff (HFA–305), Food and and/or go to the Dockets Management
VerDate Sep<11>2014 17:03 Aug 09, 2017 Jkt 241001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1](https://thefederalregister.org/doc/82_FR_37609/page/3.svg)
Document Created: 2017-08-10 01:01:24
Document Modified: 2017-08-10 01:01:24
| 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 | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Kathryn O'Callaghan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5418, Silver Spring, MD 20993-0002, (301) 796-6349. | |
| FR Citation | 82 FR 37456 |
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