Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Guidance for Industry and Food and Drug Administration Staff; Availability, 54609-54611 [2019-22194]

Download as PDF Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations’’ 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. FOR FURTHER INFORMATION CONTACT: Leigh Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993–0002, 301–796–5613. SUPPLEMENTARY INFORMATION: I. Background Hydrophilic and/or hydrophobic coated devices have been used for more than 20 years in minimally invasive diagnostic and therapeutic cerebrovascular, cardiovascular and peripheral vascular procedures. Although these devices may offer patient benefits, evidence indicates that the coating may separate from intravascular devices in some circumstances. FDA has received and analyzed information concerning serious adverse events associated with hydrophilic and/or hydrophobic coatings separating (e.g., peeling, flaking, shedding, delaminating, sloughing off) from intravascular medical devices. FDA has not concluded that any specific manufacturer or brand of these devices is associated with higher risks than others. The cause of coating separation is multifactorial, and can be associated with factors including device design, device manufacturing, and use. Current FDA analysis suggests that userelated issues may be mitigated through proper device selection, preparation, and other labeling considerations that are addressed within this guidance. This guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance is to provide recommendations for information to be included in the device labeling, as submitted in PMAs or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of coating information across these product areas as well as to promote the safe use of these devices in the clinical setting. FDA considered comments received on the draft guidance that appeared in the Federal Register of June 15, 2018 (83 FR 27996). FDA revised the guidance as appropriate in response to the comments. 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 labeling considerations for intravascular catheters, wires, and delivery systems with lubricious coating. 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. This guidance is also available at https:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 16016 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This 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: 21 CFR part Topic 807, subpart E ......................................................................... 814, subparts A through E ....................................................... 801 ........................................................................................... Premarket Notification ............................................................. Premarket Approval ................................................................ Medical Device Labeling Regulations ..................................... Dated: October 4, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–22192 Filed 10–9–19; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1775] BILLING CODE 4164–01–P Coronary, Peripheral, and Neurovascular Guidewires— Performance Tests and Recommended Labeling; 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 SUMMARY: VerDate Sep<11>2014 19:50 Oct 09, 2019 Jkt 250001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 54609 OMB control No. 0910–0120 0910–0231 0910–0485 announcing the availability of a final guidance entitled ‘‘Coronary, Peripheral, and Neurovascular Guidewires— Performance Tests and Recommended Labeling.’’ This guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature. DATES: The announcement of the guidance is published in the Federal Register on October 10, 2019. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: E:\FR\FM\10OCN1.SGM 10OCN1 54610 Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices 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–1775 for ‘‘Coronary, Peripheral, and Neurovascular Guidewires— Performance Tests and Recommended Labeling.’’ 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 VerDate Sep<11>2014 19:50 Oct 09, 2019 Jkt 250001 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:// 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 guidance document entitled ‘‘Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling’’ 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 selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Nicole Goodsell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2309, Silver Spring, MD 20993–0002, 240–402–6600. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of a guidance for industry and FDA staff entitled ‘‘Coronary, Peripheral, and Neurovascular Guidewires— Performance Tests and Recommended Labeling.’’ This guidance updates and clarifies performance testing and labeling recommendations to support a premarket notification (510(k) submission) for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. This guidance is also intended to assist industry in designing and executing appropriate performance testing to support a premarket notification and provides recommendations for content and labeling to include in the submission. FDA considered comments received on the draft guidance that appeared in the Federal Register of June 15, 2018 (83 FR 27998). FDA revised the guidance as appropriate in response to the comments. This guidance supersedes ‘‘Coronary and Cerebrovascular Guidewire Guidance,’’ dated January 1995 (available at: https:// www.fda.gov/downloads/ MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM080789.pdf). 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 coronary, peripheral, and neurovascular guidewires performance tests and recommended labeling. 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. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy E:\FR\FM\10OCN1.SGM 10OCN1 54611 Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices of ‘‘Coronary, Peripheral, and Neurovascular Guidewires— Performance Tests and Recommended Labeling’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 16007 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This 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 and guidance have been approved by OMB as listed in the following table: 21 CFR part; guidance; or FDA form Topic 807, subpart E ......................................................................... 812 ........................................................................................... ‘‘Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff’’. 800, 801, and 809 .................................................................... 820 ........................................................................................... Premarket notification ............................................................. Investigational Device Exemption ........................................... Q-submissions ......................................................................... 0910–0120 0910–0078 0910–0756 Medical Device Labeling Regulations ..................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. 0910–0485 0910–0073 Dated: October 4, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–22194 Filed 10–9–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–4041] Advancing the Development of Pediatric Therapeutics: Pediatric Clinical Trial Endpoints for Rare Diseases With a Focus on Pediatric Patient Perspectives; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Office of Pediatric Therapeutics, Food and Drug Administration (FDA), is announcing a public workshop entitled ‘‘Advancing the Development of Pediatric Therapeutics (ADEPT 6): Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives.’’ The purpose of this workshop is to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases. DATES: The public workshop will be held on November 12, 2019, from 8 a.m. to 4:30 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503–A), Silver Spring, MD 20993– 0002. Entrance for the public workshop participants (non-FDA employees) is SUMMARY: VerDate Sep<11>2014 19:50 Oct 09, 2019 Jkt 250001 through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8646, email: terrie.crescenzi@ fda.hhs.gov; or Elizabeth Sanford, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8659, email: elizabeth.sanford@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Patient engagement is critical in the development of patient-focused study endpoints that measure clinical benefit in clinical trials. Asking patients what aspects of their disease they consider important to measure is especially important for rare diseases, given the lack of established endpoints for many rare diseases, the small number of patients available for enrollment in trials, and the heterogeneity of disease manifestations (e.g., between patients and over time). While there is increased emphasis on incorporating the patient voice in rare disease drug development activities, there is an increased need for pediatric patient-specific engagement efforts. Pediatric rare disease drug development would benefit from direct and early involvement of pediatric patients and their caregivers in determining the most relevant and clinically meaningful endpoints and outcome assessment tools for use in clinical trials. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 OMB control No. II. Topics for Discussion at the Public Workshop In this workshop, FDA will obtain the pediatric patient perspective on their disease/condition and what is most important to consider when designing rare disease trials. There will also be discussion regarding patients’ thoughts on clinical endpoints that are currently being used in clinical trials, potential areas of innovation, and how to create processes that might include pediatric patients and their caregivers as collaborators in endpoint development in early stages of medical product development (e.g., protocol design). The morning session will focus on identifying endpoints that capture important aspects of how pediatric patients feel and function. The afternoon session will focus on steps for development of clinical outcome assessment tools for use in pediatric patient populations and the potential role of child and youth friendly technology in endpoint assessments. III. Participation in the Public Workshop Registration: Persons interested in attending this public workshop must register online at: https:// www.eventbrite.com/e/adept-6workshop-pediatric-clinical-trialendpoints-for-rare-diseases-registration67523118465 by November 5, 2019. For those without internet access, please contact Terrie Crescenzi or Elizabeth Sanford (see FOR FURTHER INFORMATION CONTACT) to register. Registration is free and based on space availability, with priority given to early registrants. Onsite registration on the day of the meeting will be based on space availability. Registration information, the agenda, and additional background materials can be found at https://wcms-internet.fda.gov/news- E:\FR\FM\10OCN1.SGM 10OCN1

Agencies

[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54609-54611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22194]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1775]


Coronary, Peripheral, and Neurovascular Guidewires--Performance 
Tests and Recommended Labeling; 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 a final guidance entitled ``Coronary, Peripheral, 
and Neurovascular Guidewires--Performance Tests and Recommended 
Labeling.'' This guidance provides recommendations for the information 
and testing that should be included in premarket submissions for 
guidewires intended for use in the coronary vasculature, peripheral 
vasculature, and neurovasculature.

DATES: The announcement of the guidance is published in the Federal 
Register on October 10, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

[[Page 54610]]

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-1775 for ``Coronary, Peripheral, and Neurovascular 
Guidewires--Performance Tests and Recommended Labeling.'' 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://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 guidance document entitled 
``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests 
and Recommended Labeling'' 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.

FOR FURTHER INFORMATION CONTACT: Nicole Goodsell, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2309, Silver Spring, MD 20993-0002, 240-
402-6600.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Coronary, Peripheral, and Neurovascular 
Guidewires--Performance Tests and Recommended Labeling.'' This guidance 
updates and clarifies performance testing and labeling recommendations 
to support a premarket notification (510(k) submission) for guidewires 
intended for use in the coronary vasculature, peripheral vasculature, 
and neurovasculature. The recommendations reflect current review 
practices and are intended to promote consistency and facilitate 
efficient review of these submissions. This guidance is also intended 
to assist industry in designing and executing appropriate performance 
testing to support a premarket notification and provides 
recommendations for content and labeling to include in the submission. 
FDA considered comments received on the draft guidance that appeared in 
the Federal Register of June 15, 2018 (83 FR 27998). FDA revised the 
guidance as appropriate in response to the comments. This guidance 
supersedes ``Coronary and Cerebrovascular Guidewire Guidance,'' dated 
January 1995 (available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080789.pdf).

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 coronary, peripheral, and neurovascular 
guidewires performance tests and recommended labeling. 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. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy

[[Page 54611]]

of ``Coronary, Peripheral, and Neurovascular Guidewires--Performance 
Tests and Recommended Labeling'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 16007 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This 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 and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
  21 CFR part; guidance; or FDA
              form                       Topic          OMB control No.
------------------------------------------------------------------------
807, subpart E..................  Premarket                    0910-0120
                                   notification.
812.............................  Investigational              0910-0078
                                   Device Exemption.
``Requests for Feedback on        Q-submissions......          0910-0756
 Medical Device Submissions: The
 Q-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809...............  Medical Device               0910-0485
                                   Labeling
                                   Regulations.
820.............................  Current Good                 0910-0073
                                   Manufacturing
                                   Practice (CGMP);
                                   Quality System
                                   (QS) Regulation.
------------------------------------------------------------------------


    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22194 Filed 10-9-19; 8:45 am]
 BILLING CODE 4164-01-P

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