83 FR 35658 - Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 145 (July 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 145 (July 27, 2018)
| Page Range | 35658-35659 | |
| FR Document | 2018-16029 |
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)] [Notices] [Pages 35658-35659] From the Federal Register Online [www.thefederalregister.org] [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[Docket No. FDA-2018-D-2494] Peripheral Vascular Atherectomy Devices--Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Peripheral Vascular Atherectomy Devices--Premarket Notification [510(k)] Submissions.'' This draft guidance provides recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by September 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.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:// [[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
![35658 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
notifies blood establishments that DEPARTMENT OF HEALTH AND Written/Paper Submissions
collect blood and blood components HUMAN SERVICES Submit written/paper submissions as
that we have determined babesiosis to follows:
be an RTTI under 21 CFR 630.3(h)(2) Food and Drug Administration • Mail/Hand delivery/Courier (for
and provides recommendations for [Docket No. FDA–2018–D–2494] written/paper submissions): Dockets
donor screening, donation testing, donor Management Staff (HFA–305), Food and
deferral, and product management to Peripheral Vascular Atherectomy Drug Administration, 5630 Fishers
reduce the risk of TTB. The Devices—Premarket Notification Lane, Rm. 1061, Rockville, MD 20852.
recommendations contained in the draft Submissions; Draft Guidance for • For written/paper comments
guidance document applies to the Industry and Food and Drug submitted to the Dockets Management
collection of blood and blood Administration Staff; Availability Staff, FDA will post your comment, as
components, except Source Plasma. well as any attachments, except for
AGENCY: Food and Drug Administration, information submitted, marked and
This draft guidance is being issued HHS. identified, as confidential, if submitted
consistent with FDA’s good guidance ACTION: Notice of availability. as detailed in ‘‘Instructions.’’
practices regulation (21 CFR 10.115). Instructions: All submissions received
The draft guidance, when finalized, will SUMMARY: The Food and Drug must include the Docket No. FDA–
represent the current thinking of FDA Administration (FDA or Agency) is 2018–D–2494 for ‘‘Peripheral Vascular
on recommendations for reducing the announcing the availability of the draft Atherectomy Devices—Premarket
risk of transfusion-transmitted guidance entitled ‘‘Peripheral Vascular Notification [510(k)] Submissions.’’
babesiosis. It does not establish any Atherectomy Devices—Premarket Received comments will be placed in
rights for any person and is not binding Notification [510(k)] Submissions.’’ This the docket and, except for those
on FDA or the public. You can use an draft guidance provides submitted as ‘‘Confidential
alternative approach if it satisfies the recommendations for premarket Submissions,’’ publicly viewable at
requirements of the applicable statutes submissions for a new or modified https://www.regulations.gov or at the
and regulations. This guidance is not peripheral vascular atherectomy device. Dockets Management Staff between 9
subject to Executive Order 12866. This draft guidance is not final nor is it a.m. and 4 p.m., Monday through
in effect at this time. Friday.
II. Paperwork Reduction Act of 1995 DATES: Submit either electronic or • Confidential Submissions—To
written comments on the draft guidance submit a comment with confidential
This guidance refers to previously
by September 25, 2018 to ensure that information that you do not wish to be
approved collections of information
the Agency considers your comment on made publicly available, submit your
found in FDA regulations. These this draft guidance before it begins work comments only as a written/paper
collections of information are subject to on the final version of the guidance. submission. You should submit two
review by the Office of Management and
ADDRESSES: You may submit comments copies total. One copy will include the
Budget (OMB) under the Paperwork information you claim to be confidential
on any guidance at any time as follows:
Reduction Act of 1995 (44 U.S.C. 3501– with a heading or cover note that states
3520). The collections of information in Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
21 CFR part 601 have been approved Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
under OMB control number 0910–0338, following way: Agency will review this copy, including
and the collections of information in 21 • Federal eRulemaking Portal: the claimed confidential information, in
CFR part 606, 21 CFR 610.40(h), and 21 https://www.regulations.gov. Follow the its consideration of comments. The
CFR 630.40 have been approved under instructions for submitting comments. second copy, which will have the
OMB control number 0910–0116. Comments submitted electronically, claimed confidential information
including attachments, to https:// redacted/blacked out, will be available
III. Electronic Access
www.regulations.gov will be posted to for public viewing and posted on
Persons with access to the internet the docket unchanged. Because your https://www.regulations.gov. Submit
may obtain the draft guidance at either comment will be made public, you are both copies to the Dockets Management
http://www.fda.gov/Biologics solely responsible for ensuring that your Staff. If you do not wish your name and
BloodVaccines/GuidanceCompliance comment does not include any contact information to be made publicly
RegulatoryInformation/Guidances/ confidential information that you or a available, you can provide this
default.htm or https:// third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
www.regulations.gov.
anyone else’s Social Security number, or must identify this information as
Dated: July 20, 2018. confidential business information, such ‘‘confidential.’’ Any information marked
Leslie Kux, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2018–16030 Filed 7–26–18; 8:45 am] information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
BILLING CODE 4164–01–P
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
amozie on DSK3GDR082PROD with NOTICES1
• If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
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![Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35659
www.regulations.gov and insert the I. Background III. Electronic Access
docket number, found in brackets in the Atherectomy is an interventional
heading of this document, into the Persons interested in obtaining a copy
procedure performed to debulk
‘‘Search’’ box and follow the prompts of the draft guidance may do so by
atherosclerotic plaque from diseased
and/or go to the Dockets Management downloading an electronic copy from
arteries. Atherectomy has been used in
Staff, 5630 Fishers Lane, Rm. 1061, treatment of both coronary and the internet. A search capability for all
Rockville, MD 20852. peripheral arterial disease. FDA has Center for Devices and Radiological
developed this draft guidance for Health guidance documents is available
You may submit comments on any
guidance at any time (see 21 CFR members of industry who submit and at https://www.fda.gov/MedicalDevices/
10.115(g)(5)). FDA staff who review premarket DeviceRegulationandGuidance/
submissions for atherectomy devices GuidanceDocuments/default.htm. This
An electronic copy of the guidance guidance document is also available at
used in the peripheral vasculature.
document is available for download https://www.regulations.gov. Persons
When finalized, this guidance is
from the internet. See the unable to download an electronic copy
intended to provide recommendations
SUPPLEMENTARY INFORMATION section for
for information to include in premarket of ‘‘Peripheral Vascular Atherectomy
information on electronic access to the notifications (510(k)) for peripheral Devices—Premarket Notification
guidance. Submit written requests for a vascular atherectomy devices (e.g., [510(k)] Submissions’’ may send an
single hard copy of the draft guidance descriptive characteristics, labeling, email request to CDRH-Guidance@
document entitled ‘‘Peripheral Vascular biocompatibility, sterility, non-clinical,
Atherectomy Devices—Premarket fda.hhs.gov to receive an electronic
animal, and clinical performance copy of the document. Please use the
Notification [510(k)] Submissions’’ to testing).
the Office of the Center Director, document number 16013 to identify the
Guidance and Policy Development, II. Significance of Guidance guidance you are requesting.
Center for Devices and Radiological This draft guidance is being issued IV. Paperwork Reduction Act of 1995
Health, Food and Drug Administration, consistent with FDA’s good guidance
10903 New Hampshire Ave., Bldg. 66, practices regulation (21 CFR 10.115). This draft guidance refers to
Rm. 5431, Silver Spring, MD 20993– The draft guidance, when finalized, will previously approved collections of
0002. Send one self-addressed adhesive represent the current thinking of FDA information found in FDA regulations.
label to assist that office in processing on ‘‘Peripheral Vascular Atherectomy These collections of information are
your request. Devices—Premarket Notification subject to review by the Office of
FOR FURTHER INFORMATION CONTACT:
[510(k)] Submissions.’’ It does not Management and Budget (OMB) under
establish any rights for any person and the Paperwork Reduction Act of 1995
Misti Malone, Center for Devices and
is not binding on FDA or the public. (44 U.S.C. 3501–3520). The collections
Radiological Health, Food and Drug
You can use an alternative approach if of information in the following FDA
Administration, 10903 New Hampshire
it satisfies the requirements of the regulations and guidance have been
Ave., Bldg. 66, Rm. 120, Silver Spring,
applicable statutes and regulations. This approved by OMB as listed in the
MD 20993–0002, 301–796–2520.
guidance is not subject to Executive following table:
SUPPLEMENTARY INFORMATION: Order 12866.
OMB Control
21 CFR part Topic No.
807, subpart E .......................................... Premarket Notification .................................................................................................. 0910–0120
812 ............................................................ Investigational Device Exemption ................................................................................ 0910–0078
820 ............................................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... 0910–0073
807, subparts A through D ....................... Electronic Submission of Medical Device Registration and Listing ............................. 0910–0625
50, 56 ........................................................ Protection of Human Subjects: Informed Consent; Institutional Review Boards ........ 0910–0755
56 .............................................................. Institutional Review Boards .......................................................................................... 0910–0130
58 .............................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies ..... 0910–0119
801.150(a)(2) and (e) ............................... Agreement for Shipments of Devices for Sterilization ................................................. 0910–0131
Dated: July 20, 2018. DEPARTMENT OF HEALTH AND fiscal year (FY) 2019 fee rates for certain
Leslie Kux, HUMAN SERVICES domestic and foreign facility
Associate Commissioner for Policy. reinspections, failures to comply with a
Food and Drug Administration recall order, and importer reinspections
[FR Doc. 2018–16029 Filed 7–26–18; 8:45 am]
BILLING CODE 4164–01–P [Docket No. FDA–2018–N–2775] that are authorized by the Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
Food Safety Modernization Act amended by the FDA Food Safety
Domestic and Foreign Facility Modernization Act (FSMA). These fees
Reinspection, Recall, and Importer are effective on October 1, 2018, and
Reinspection Fee Rates for Fiscal Year will remain in effect through September
amozie on DSK3GDR082PROD with NOTICES1
2019 30, 2019.
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
HHS. Jason Lewis, Office of Management,
ACTION: Notice. Office of Regulatory Affairs, Food and
SUMMARY: The Food and Drug Drug Administration, 12420 Parklawn
Administration (FDA) is announcing the Dr., Rm. 2406, Rockville, MD 20857,
VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1](https://thefederalregister.org/doc/83_FR_35803/page/2.svg)
Document Created: 2018-07-27 04:05:33
Document Modified: 2018-07-27 04:05:33
| 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 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. | |
| 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. | |
| FR Citation | 83 FR 35658 |
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