2020-15081. Select Updates for Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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AGENCY:
Food and Drug Administration, Health and Human Services (HHS).
ACTION:
Notice of availability.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Select Updates for Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions.” FDA has developed this draft guidance to propose select updates to certain sections of the existing FDA guidance document “Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions.” This draft guidance is not final nor is it in effect at this time.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Submit either electronic or written comments on the draft guidance by September 11, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 Start Printed Page 41988solely 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 “Select Updates 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.govinfo.gov/content/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)).
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 “Select Updates for Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions” to the Office of Policy, 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.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Jhumur Banik, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2223, Silver Spring, MD 20993-0002, 240-402-5239.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this draft guidance to propose select updates to the FDA guidance document “Peripheral Vascular Atherectomy Devices—Premarket Notification (510(k)) Submissions.” The existing guidance on atherectomy devices remains in effect, in its current form, until this draft guidance is finalized. FDA intends to incorporate this draft guidance into one final guidance document after obtaining and considering public comment on these select updates. FDA does not intend to substantively change the sections of the existing atherectomy guidance that are not affected by this select update.
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 “Select Updates for 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.
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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Select Updates for 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 19047 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of information. 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. 3501-3521). The collections of information in the following FDA regulations have been approved by OMB as listed in the following table:
Start Signature21 CFR part or guidance Topic OMB control No. 807, subpart E Premarket notification 0910-0120 820 Quality System Regulations 0910-0073 Start Printed Page 41989End Signature End Supplemental InformationDated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15081 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P
Document Information
- Published:
- 07/13/2020
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice of availability.
- Document Number:
- 2020-15081
- Dates:
- Submit either electronic or written comments on the draft guidance by September 11, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Pages:
- 41987-41989 (3 pages)
- Docket Numbers:
- Docket No. FDA-2018-D-2494
- PDF File:
- 2020-15081.pdf
- Supporting Documents:
- » Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions Guidance for Industry and Food and Drug Administration Staff
- » Peripheral Vascular Atherectomy Devices—Premarket Notification Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- » Select Updates for Peripheral Vascular Atherectomy Devices—Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- » Select Updates for Peripheral Vascular Atherectomy Devices—Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- » Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions; Guidance for Industry and Food and Drug Administration Staff
- » Peripheral Vascular Atherectomy Devices—Premarket Notification Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- » Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: July 27, 2018
- » Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability