83 FR 25014 - Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 105 (May 31, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 105 (May 31, 2018)
| Page Range | 25014-25015 | |
| FR Document | 2018-11603 |
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)] [Notices] [Pages 25014-25015] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11603] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1329] Recommended Content and Format of Complete Test Reports for Non- Clinical Bench Performance Testing in Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo classification requests). This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by July 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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.'' Instructions: All submissions received must include the Docket No. FDA-2018-D-1329 for ``Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.'' 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). [[Page 25015]] 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 ``Recommended Content and Format of Complete Test Reports for Non- Clinical Bench Performance Testing in Premarket Submissions'' 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: Mary Wen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 240-402-4913. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ``Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in complete test reports for non- clinical bench performance testing provided in a premarket submission (i.e., PMA applications, HDE applications, 510(k) submissions, IDE applications, and De Novo classification requests). Non-clinical bench performance testing is defined as performance testing that encompasses all bench testing and will be dependent upon the specifics of the actual device or device type. Non-clinical bench performance testing includes, but is not limited to, mechanical and biological engineering performance such as fatigue, wear, tensile strength, compression, and burst pressure; bench tests using animal or human tissue; and animal carcass or human cadaveric testing. Non- clinical bench performance testing excludes biocompatibility evaluation, sterilization, and animal in vivo evaluation. This draft guidance is intended to help ensure that clear and consistent information is provided in premarket submissions containing non-clinical bench performance testing. The information in this draft guidance is intended to be used in conjunction with other FDA guidance documents, including device-specific guidances. 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 current thinking of FDA on ``Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.'' 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 draft 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. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 18011 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 the following FDA regulations and guidances have been approved by OMB as listed: ------------------------------------------------------------------------ OMB control 21 CFR part or guidance Topic No. ------------------------------------------------------------------------ 807, Subpart E.................... Premarket 0910-0120 Notification. 814, Subparts A Through E......... Premarket Approval.. 0910-0231 814, Subpart H.................... Humanitarian Device 0910-0332 Exemption. 812............................... Investigational 0910-0078 Device Exemption. De Novo Classification Process De Novo 0910-0844 (Evaluation of Automatic Class Classification III Designation). process. ------------------------------------------------------------------------ Dated: May 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-11603 Filed 5-30-18; 8:45 am] BILLING CODE 4164-01-P
![25014 Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
Hampshire Ave., Bldg. 22, Rm. 4166, Reports for Non-Clinical Bench well as any attachments, except for
Silver Spring, MD 20903, 301–796– Performance Testing in Premarket information submitted, marked and
2240. Submissions.’’ FDA has developed this identified, as confidential, if submitted
SUPPLEMENTARY INFORMATION:
document to describe relevant as detailed in ‘‘Instructions.’’
information that should be included in Instructions: All submissions received
I. Background complete test reports for non-clinical must include the Docket No. FDA–
FDA is announcing the availability of bench performance testing provided in 2018–D–1329 for ‘‘Recommended
a draft guidance for industry entitled a premarket submission (i.e., premarket Content and Format of Complete Test
‘‘Assessment of Pressor Effects of approval (PMA) applications, Reports for Non-Clinical Bench
Drugs.’’ Elevated blood pressure is humanitarian device exemption (HDE) Performance Testing in Premarket
known to increase the risk of stroke, applications, premarket notification Submissions.’’ Received comments will
heart attack, and death. The effect of a (510(k)) submissions, investigational be placed in the docket and, except for
drug on blood pressure may therefore be device exemption (IDE) applications, those submitted as ‘‘Confidential
an important consideration in benefit- and De Novo classification requests). Submissions,’’ publicly viewable at
risk assessment. This guidance is This draft guidance is not final nor is it https://www.regulations.gov or at the
intended to advise sponsors on the in effect at this time. Dockets Management Staff between 9
premarketing assessment of a drug’s DATES: Submit either electronic or a.m. and 4 p.m., Monday through
effect on blood pressure. written comments on the draft guidance Friday.
This draft guidance is being issued by July 30, 2018 to ensure that the • Confidential Submissions—To
consistent with FDA’s good guidance Agency considers your comment on this submit a comment with confidential
practices regulation (21 CFR 10.115). draft guidance before it begins work on information that you do not wish to be
The draft guidance, when finalized, will the final version of the guidance. made publicly available, submit your
represent the current thinking of FDA ADDRESSES: You may submit comments comments only as a written/paper
on assessment of pressor effects of on any guidance at any time as follows: submission. You should submit two
drugs. It does not establish any rights for copies total. One copy will include the
any person and is not binding on FDA Electronic Submissions information you claim to be confidential
or the public. You can use an alternative Submit electronic comments in the with a heading or cover note that states
approach if it satisfies the requirements following way: ‘‘THIS DOCUMENT CONTAINS
of the applicable statutes and • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
regulations. This guidance is not subject https://www.regulations.gov. Follow the Agency will review this copy, including
to Executive Order 12866. instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
II. Electronic Access second copy, which will have the
including attachments, to https://
Persons with access to the internet www.regulations.gov will be posted to claimed confidential information
may obtain the draft guidance at either the docket unchanged. Because your redacted/blacked out, will be available
https://www.fda.gov/Drugs/Guidance comment will be made public, you are for public viewing and posted on
ComplianceRegulatoryInformation/ solely responsible for ensuring that your https://www.regulations.gov. Submit
Guidances/default.htm or https:// comment does not include any both copies to the Dockets Management
www.regulations.gov. confidential information that you or a Staff. If you do not wish your name and
Dated: May 24, 2018. third party may not wish to be posted, contact information to be made publicly
Leslie Kux, such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
Associate Commissioner for Policy.
confidential business information, such in the body of your comments and you
[FR Doc. 2018–11642 Filed 5–30–18; 8:45 am]
as a manufacturing process. Please note must identify this information as
BILLING CODE 4164–01–P ‘‘confidential.’’ Any information marked
that if you include your name, contact
information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
DEPARTMENT OF HEALTH AND and other applicable disclosure law. For
HUMAN SERVICES comments, that information will be
posted on https://www.regulations.gov. more information about FDA’s posting
Food and Drug Administration • If you want to submit a comment of comments to public dockets, see 80
with confidential information that you FR 56469, September 18, 2015, or access
[Docket No. FDA–2018–D–1329] do not wish to be made available to the the information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
Recommended Content and Format of 23389.pdf.
Complete Test Reports for Non-Clinical written/paper submission and in the
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Bench Performance Testing in read background documents or the
Premarket Submissions; Draft Submissions’’ and ‘‘Instructions’’).
electronic and written/paper comments
Guidance for Industry and Food and Written/Paper Submissions received, go to https://
Drug Administration Staff; Availability www.regulations.gov and insert the
Submit written/paper submissions as
AGENCY: Food and Drug Administration, follows: docket number, found in brackets in the
HHS. • Mail/Hand delivery/Courier (for heading of this document, into the
amozie on DSK3GDR082PROD with NOTICES1
ACTION: Notice of availability. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and and/or go to the Dockets Management
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
announcing the availability of the draft • For written/paper comments You may submit comments on any
guidance entitled ‘‘Recommended submitted to the Dockets Management guidance at any time (see 21 CFR
Content and Format of Complete Test Staff, FDA will post your comment, as 10.115(g)(5)).
VerDate Sep<11>2014 17:46 May 30, 2018 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1](https://thefederalregister.org/doc/83_FR_25119/page/1.svg)
![Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices 25015
An electronic copy of the guidance applications, HDE applications, 510(k) You can use an alternative approach if
document is available for download submissions, IDE applications, and De it satisfies the requirements of the
from the internet. See the Novo classification requests). applicable statutes and regulations. This
SUPPLEMENTARY INFORMATION section for Non-clinical bench performance guidance is not subject to Executive
information on electronic access to the testing is defined as performance testing Order 12866.
guidance. Submit written requests for a that encompasses all bench testing and
will be dependent upon the specifics of III. Electronic Access
single hard copy of the draft guidance
document entitled ‘‘Recommended the actual device or device type. Non- Persons interested in obtaining a copy
Content and Format of Complete Test clinical bench performance testing of the draft guidance may do so by
Reports for Non-Clinical Bench includes, but is not limited to, downloading an electronic copy from
Performance Testing in Premarket mechanical and biological engineering the internet. A search capability for all
Submissions’’ to the Office of the Center performance such as fatigue, wear, Center for Devices and Radiological
Director, Guidance and Policy tensile strength, compression, and burst Health guidance documents is available
Development, Center for Devices and pressure; bench tests using animal or at https://www.fda.gov/MedicalDevices/
Radiological Health, Food and Drug human tissue; and animal carcass or DeviceRegulationandGuidance/
Administration, 10903 New Hampshire human cadaveric testing. Non-clinical GuidanceDocuments/default.htm. This
Ave., Bldg. 66, Rm. 5431, Silver Spring, bench performance testing excludes guidance document is also available at
MD 20993–0002. Send one self- biocompatibility evaluation, https://www.regulations.gov. Persons
addressed adhesive label to assist that sterilization, and animal in vivo unable to download an electronic copy
office in processing your request. evaluation. of ‘‘Recommended Content and Format
This draft guidance is intended to
FOR FURTHER INFORMATION CONTACT: of Complete Test Reports for Non-
help ensure that clear and consistent
Mary Wen, Center for Devices and Clinical Bench Performance Testing in
information is provided in premarket
Radiological Health, Food and Drug Premarket Submissions’’ may send an
submissions containing non-clinical
Administration, 10903 New Hampshire bench performance testing. The email request to CDRH-Guidance@
Ave., Bldg. 66, Rm. 1529, Silver Spring, information in this draft guidance is fda.hhs.gov to receive an electronic
MD 20993–0002, 240–402–4913. intended to be used in conjunction with copy of the document. Please use the
SUPPLEMENTARY INFORMATION: other FDA guidance documents, document number 18011 to identify the
including device-specific guidances. guidance you are requesting.
I. Background
II. Significance of Guidance IV. Paperwork Reduction Act of 1995
FDA is announcing the availability of
a draft guidance for industry and FDA This draft guidance is being issued This draft guidance refers to
staff entitled ‘‘Recommended Content consistent with FDA’s good guidance previously approved collections of
and Format of Complete Test Reports for practices regulation (21 CFR 10.115). information found in FDA regulations.
Non-Clinical Bench Performance The draft guidance, when finalized, will These collections of information are
Testing in Premarket Submissions.’’ represent the current thinking of FDA subject to review by the Office of
FDA has developed this document to on ‘‘Recommended Content and Format Management and Budget (OMB) under
describe relevant information that of Complete Test Reports for Non- the Paperwork Reduction Act of 1995
should be included in complete test Clinical Bench Performance Testing in (44 U.S.C. 3501–3520). The collections
reports for non-clinical bench Premarket Submissions.’’ It does not of information in the following FDA
performance testing provided in a establish any rights for any person and regulations and guidances have been
premarket submission (i.e., PMA is not binding on FDA or the public. approved by OMB as listed:
OMB control
21 CFR part or guidance Topic No.
807, Subpart E ........................................................................... Premarket Notification ................................................................ 0910–0120
814, Subparts A Through E ....................................................... Premarket Approval .................................................................... 0910–0231
814, Subpart H ........................................................................... Humanitarian Device Exemption ................................................ 0910–0332
812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078
De Novo Classification Process (Evaluation of Automatic Class De Novo Classification process ................................................. 0910–0844
III Designation).
Dated: May 24, 2018. DEPARTMENT OF HEALTH AND ACTION: Notice.
Leslie Kux, HUMAN SERVICES
SUMMARY: The Food and Drug
Associate Commissioner for Policy. Administration (FDA or Agency) is
Food and Drug Administration
[FR Doc. 2018–11603 Filed 5–30–18; 8:45 am] announcing an opportunity for public
BILLING CODE 4164–01–P comment on the proposed collection of
[Docket No. FDA–2011–N–0908]
certain information by the Agency.
Agency Information Collection Under the Paperwork Reduction Act of
Activities; Proposed Collection; 1995 (PRA), Federal Agencies are
amozie on DSK3GDR082PROD with NOTICES1
Comment Request; Guidance for required to publish notice in the
Clinical Trial Sponsors: Establishment Federal Register concerning each
and Operation of Clinical Trial Data proposed collection of information,
Monitoring Committees including each proposed extension of an
existing collection of information, and
AGENCY: Food and Drug Administration, to allow 60 days for public comment in
HHS. response to the notice. This notice
VerDate Sep<11>2014 17:46 May 30, 2018 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1](https://thefederalregister.org/doc/83_FR_25119/page/2.svg)
Document Created: 2018-05-31 00:49:09
Document Modified: 2018-05-31 00:49:09
| 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 the draft guidance by July 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Mary Wen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 240-402-4913. | |
| FR Citation | 83 FR 25014 |
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