Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 35658-35659 [2018-16029]

Download as PDF 35658 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices notifies blood establishments that collect blood and blood components that we have determined babesiosis to be an RTTI under 21 CFR 630.3(h)(2) and provides recommendations for donor screening, donation testing, donor deferral, and product management to reduce the risk of TTB. The recommendations contained in the draft guidance document applies to the collection of blood and blood components, except Source Plasma. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on recommendations for reducing the risk of transfusion-transmitted babesiosis. 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. II. 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 21 CFR part 601 have been approved under OMB control number 0910–0338, and the collections of information in 21 CFR part 606, 21 CFR 610.40(h), and 21 CFR 630.40 have been approved under OMB control number 0910–0116. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: July 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–16030 Filed 7–26–18; 8:45 am] amozie on DSK3GDR082PROD with NOTICES1 BILLING CODE 4164–01–P VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2494] Peripheral Vascular Atherectomy Devices—Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] Submissions.’’ This draft guidance provides recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. 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 September 25, 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: SUMMARY: 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’’). PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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–2494 for ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// E:\FR\FM\27JYN1.SGM 27JYN1 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 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)). 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 ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] 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: Misti Malone, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 120, Silver Spring, MD 20993–0002, 301–796–2520. SUPPLEMENTARY INFORMATION: I. Background Atherectomy is an interventional procedure performed to debulk atherosclerotic plaque from diseased arteries. Atherectomy has been used in treatment of both coronary and peripheral arterial disease. FDA has developed this draft guidance for members of industry who submit and FDA staff who review premarket submissions for atherectomy devices used in the peripheral vasculature. When finalized, this guidance is intended to provide recommendations for information to include in premarket notifications (510(k)) for peripheral vascular atherectomy devices (e.g., descriptive characteristics, labeling, biocompatibility, sterility, non-clinical, animal, and clinical performance testing). 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 ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] 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 ‘‘Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] Submissions’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 16013 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 guidance have been approved by OMB as listed in the following table: OMB Control No. 21 CFR part Topic 807, subpart E .......................................... 812 ............................................................ 820 ............................................................ 807, subparts A through D ....................... 50, 56 ........................................................ 56 .............................................................. 58 .............................................................. 801.150(a)(2) and (e) ............................... Premarket Notification .................................................................................................. Investigational Device Exemption ................................................................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... Electronic Submission of Medical Device Registration and Listing ............................. Protection of Human Subjects: Informed Consent; Institutional Review Boards ........ Institutional Review Boards .......................................................................................... Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies ..... Agreement for Shipments of Devices for Sterilization ................................................. Dated: July 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–16029 Filed 7–26–18; 8:45 am] Food and Drug Administration [Docket No. FDA–2018–N–2775] BILLING CODE 4164–01–P amozie on DSK3GDR082PROD with NOTICES1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the SUMMARY: VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 35659 0910–0120 0910–0078 0910–0073 0910–0625 0910–0755 0910–0130 0910–0119 0910–0131 fiscal year (FY) 2019 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019. FOR FURTHER INFORMATION CONTACT: Jason Lewis, Office of Management, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rm. 2406, Rockville, MD 20857, E:\FR\FM\27JYN1.SGM 27JYN1

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[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35658-35659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16029]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2494]


Peripheral Vascular Atherectomy Devices--Premarket Notification 
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 ``Peripheral Vascular 
Atherectomy Devices--Premarket Notification [510(k)] Submissions.'' 
This draft guidance provides recommendations for premarket submissions 
for a new or modified peripheral vascular atherectomy device. 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 September 25, 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-2494 for ``Peripheral Vascular Atherectomy Devices--
Premarket Notification [510(k)] 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.gpo.gov/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://

[[Page 35659]]

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)).
    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 
``Peripheral Vascular Atherectomy Devices--Premarket Notification 
[510(k)] 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: Misti Malone, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 120, Silver Spring, MD 20993-0002, 301-796-2520.

SUPPLEMENTARY INFORMATION:

I. Background

    Atherectomy is an interventional procedure performed to debulk 
atherosclerotic plaque from diseased arteries. Atherectomy has been 
used in treatment of both coronary and peripheral arterial disease. FDA 
has developed this draft guidance for members of industry who submit 
and FDA staff who review premarket submissions for atherectomy devices 
used in the peripheral vasculature. When finalized, this guidance is 
intended to provide recommendations for information to include in 
premarket notifications (510(k)) for peripheral vascular atherectomy 
devices (e.g., descriptive characteristics, labeling, biocompatibility, 
sterility, non-clinical, animal, and clinical performance testing).

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 ``Peripheral 
Vascular Atherectomy Devices--Premarket Notification [510(k)] 
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 ``Peripheral Vascular 
Atherectomy Devices--Premarket Notification [510(k)] Submissions'' may 
send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 16013 
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 
guidance have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB Control
          21 CFR part                     Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
812............................  Investigational Device        0910-0078
                                  Exemption.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
807, subparts A through D......  Electronic Submission         0910-0625
                                  of Medical Device
                                  Registration and
                                  Listing.
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
56.............................  Institutional Review          0910-0130
                                  Boards.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
801.150(a)(2) and (e)..........  Agreement for Shipments       0910-0131
                                  of Devices for
                                  Sterilization.
------------------------------------------------------------------------


    Dated: July 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16029 Filed 7-26-18; 8:45 am]
BILLING CODE 4164-01-P

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