Safety and Performance Based Pathway Device-Specific Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability, 49655-49657 [2020-17771]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 85, No. 158 / Friday, August 14, 2020 / Notices contact Stephanie Watson at 301–492– 4238. 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy; Use: CMS provides coverage for carotid artery stenting (CAS) with embolic protection for patients at high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis between 50 percent and 70 percent or have asymptomatic carotid artery stenosis ≥80 percent in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), a trial under the CMS Clinical Trial Policy (NCD Manual § 310.1, or in accordance with the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7 CMS also covers CAS with embolic protection for patients at high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis ≥70 percent performed in facilities that have been determined to be competent in performing the evaluation, procedure and follow-up necessary to ensure optimal patient outcomes. In accordance with this criteria, we consider coverage for CAS reasonable and necessary (section 1862 (A)(1)(a) of the Social Security Act). Form Number: CMS–10199 (OMB control number: 0938–1011); Frequency: Yearly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 1,420; Total Annual Responses: 3,313; Total Annual Hours: 30,057. (For policy questions regarding this collection contact Sarah Fulton at 410–786–2749.) 3. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations; Use: The information collection requirements described herein are part of the Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities. The requirements fall into three categories: Record keeping, reporting, and disclosure. With regard to the record keeping requirements, CMS uses these conditions for coverage to certify health care facilities that want to participate in the Medicare or Medicaid programs. For the reporting requirements, the information is needed to assess and ensure proper distribution and effective VerDate Sep<11>2014 17:29 Aug 13, 2020 Jkt 250001 utilization of ESRD treatment resources while maintaining or improving quality of care. All of the reports specified in this document are geared toward ensuring that facilities achieve quality and cost-effective service provision. Collection of this information is authorized by Section 1881 of the Act and required by 42 CFR 405.2100 through 405.2171 (now at 42 CFR 414.330, 488.60, and 494.100–494.180). Depending on the outcome of litigation, disclosures may be required by Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. Form Number: CMS–R–52 (OMB Control Number: 0938–0386); Frequency: Annually; Affected Public: Private sector—Business or other for-profit; Number of Respondents: 8,246; Total Annual Responses: 171,795; Total Annual Hours: 1,260,491. (For policy questions regarding this collection contact Eric Laib at 410–786–9759.) 4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Clinical Laboratory Improvement Amendments (CLIA) Regulations; Use: The information is necessary to determine an entity’s compliance with the Congressionally-mandated program with respect to the regulation of laboratory testing (CLIA). In addition, laboratories participating in the Medicare program must comply with CLIA requirements as required by section 6141 of OBRA 89. Medicaid, under the authority of section 1902(a)(9)(C) of the Social Security Act, pays for services furnished only by laboratories that meet Medicare (CLIA) requirements. Form Number: CMS–R– 26 (OMB Control Number: 0938–0612); Frequency: Monthly, occasionally; Affected Public: Business or other forprofits and Not-for-profit institutions, State, Local or Tribal Governments, and the Federal government; Number of Respondents: 34,579; Total Annual Responses: 74,476,376; Total Annual Hours: 14,514,802. (For policy questions regarding this collection contact Raelene Perfetto at 410–786–6876). Dated: August 11, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2020–17852 Filed 8–13–20; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 49655 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2019–D–1649 and FDA– 2019–D–1651] Safety and Performance Based Pathway Device-Specific Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: The Food and Drug Administration (FDA or Agency) is announcing the availability of two final device-specific guidance documents for the Safety and Performance Based Pathway—specifically, ‘‘Cutaneous Electrode for Recording Purposes— Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff’’ and ‘‘Conventional Foley Catheters— Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.’’ The devicespecific guidances identified in this notice were developed in accordance with the finalized guidance entitled ‘‘Safety and Performance Based Pathway.’’ DATES: The announcement of the guidance is published in the Federal Register on August 14, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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. E:\FR\FM\14AUN1.SGM 14AUN1 49656 Federal Register / Vol. 85, No. 158 / Friday, August 14, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES • 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– 2019–D–1649 for ‘‘Cutaneous Electrode for Recording Purposes—Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff’’ and Docket No. FDA–2019–D– 1651 for ‘‘Conventional Foley Catheters—Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.’’ Received comments will be placed in the dockets 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, 240–402–7500. • 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 VerDate Sep<11>2014 17:29 Aug 13, 2020 Jkt 250001 ‘‘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-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidances is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidances. Submit written requests for a single hard copy of the guidance document entitled ‘‘Cutaneous Electrode for Recording Purposes—Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff’’ or ‘‘Conventional Foley Catheters—Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff ’’ 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: Jason Ryans, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993–0002, 301–796–4908. SUPPLEMENTARY INFORMATION: I. Background These device-specific guidance documents provide performance criteria for premarket notification (510(k)) submissions to support the optional Safety and Performance Based Pathway, as described in the guidance entitled ‘‘Safety and Performance Based PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Pathway. ‘‘ 1 As described in that guidance, substantial equivalence is rooted in comparisons between new devices and predicate devices. However, the Federal Food, Drug, and Cosmetic Act does not preclude FDA from using performance criteria to facilitate this comparison. If a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device(s). Under this optional Safety and Performance Based Pathway, a submitter could satisfy the requirement to compare its device with a legally marketed device by, among other things, independently demonstrating that the device’s performance meets performance criteria as established in the above-listed guidances, rather than using direct predicate comparison testing for some of the performance characteristics. A notice of availability of the draft guidances appeared in the Federal Register of September 20, 2019 (84 FR 49528). FDA did not receive comments on the ‘‘Cutaneous Electrode for Recording Purposes’’ guidance; FDA considered comments received on the ‘‘Conventional Foley Catheters’’ guidance and revised the guidance as appropriate, including by clarifying, in the discussion of Biocompatibility Evaluation, when material mediated pyrogenicity testing is recommended. These guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidances represent the current thinking of FDA on performance criteria for the ‘‘Cutaneous Electrode for Recording Purposes’’ and ‘‘Conventional Foley Catheters.’’ They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons interested in obtaining a copy of the guidances may do so by downloading an electronic copy from the internet. A search capability for all 1 Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ safety-and-performance-based-pathway. E:\FR\FM\14AUN1.SGM 14AUN1 Federal Register / Vol. 85, No. 158 / Friday, August 14, 2020 / Notices Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of either ‘‘Cutaneous Electrode for Recording Purposes—Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff (document number 19014)’’ or ‘‘Conventional Foley Catheters— Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff (document number 19010)’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 These guidances contains no collections of information. Therefore, Topic 807, subpart E ......................................................................................................................................... ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. Premarket notification .... Q-submissions ............... In the Federal Register of July 23, 2020, 85 FR 44541, FDA announced that a meeting of the Pediatric Advisory Committee would be held on September 15, 2020. On page 44542, in the third column, the Procedure portion of the document is changed to read as follows: Oral presentations from the public will be scheduled between approximately 11:30 a.m. to 12:30 p.m. Eastern Time. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. SUPPLEMENTARY INFORMATION: [FR Doc. 2020–17771 Filed 8–13–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1648] Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Amendment of Notice Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of July 23, 2020. The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240–402–3838, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. Dated: August 10, 2020. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2020–17775 Filed 8–13–20; 8:45 am] BILLING CODE 4164–01–P SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521) is not required. However, these guidances refer to previously approved collections of information. These collections of information are subject to review by OMB under the PRA. 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 Dated: August 7, 2020. Lauren K. Roth, Associate Commissioner for Policy. VerDate Sep<11>2014 17:29 Aug 13, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1677] Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 49657 OMB control No. 0910–0120 0910–0756 The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle. SUMMARY: Submit either electronic or written comments on the collection of information by October 13, 2020. DATES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 13, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: E:\FR\FM\14AUN1.SGM 14AUN1

Agencies

[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49655-49657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17771]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-D-1649 and FDA-2019-D-1651]


Safety and Performance Based Pathway Device-Specific Guidances; 
Guidances for Industry and Food and Drug Administration Staff; 
Availability

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 two final device-specific guidance documents for 
the Safety and Performance Based Pathway--specifically, ``Cutaneous 
Electrode for Recording Purposes--Performance Criteria for Safety and 
Performance Based Pathway; Guidance for Industry and Food and Drug 
Administration Staff'' and ``Conventional Foley Catheters--Performance 
Criteria for Safety and Performance Based Pathway; Guidance for 
Industry and Food and Drug Administration Staff.'' The device-specific 
guidances identified in this notice were developed in accordance with 
the finalized guidance entitled ``Safety and Performance Based 
Pathway.''

DATES: The announcement of the guidance is published in the Federal 
Register on August 14, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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.

[[Page 49656]]

     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-2019-D-1649 for ``Cutaneous Electrode for Recording Purposes--
Performance Criteria for Safety and Performance Based Pathway; Guidance 
for Industry and Food and Drug Administration Staff'' and Docket No. 
FDA-2019-D-1651 for ``Conventional Foley Catheters--Performance 
Criteria for Safety and Performance Based Pathway; Guidance for 
Industry and Food and Drug Administration Staff.'' Received comments 
will be placed in the dockets 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, 240-402-7500.
     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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidances is available for download from 
the internet. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidances. Submit written requests for a 
single hard copy of the guidance document entitled ``Cutaneous 
Electrode for Recording Purposes--Performance Criteria for Safety and 
Performance Based Pathway; Guidance for Industry and Food and Drug 
Administration Staff'' or ``Conventional Foley Catheters--Performance 
Criteria for Safety and Performance Based Pathway; Guidance for 
Industry and Food and Drug Administration Staff '' 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: Jason Ryans, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-4908.

SUPPLEMENTARY INFORMATION:

I. Background

    These device-specific guidance documents provide performance 
criteria for premarket notification (510(k)) submissions to support the 
optional Safety and Performance Based Pathway, as described in the 
guidance entitled ``Safety and Performance Based Pathway. `` \1\ As 
described in that guidance, substantial equivalence is rooted in 
comparisons between new devices and predicate devices. However, the 
Federal Food, Drug, and Cosmetic Act does not preclude FDA from using 
performance criteria to facilitate this comparison. If a legally 
marketed device performs at certain levels relevant to its safety and 
effectiveness, and a new device meets those levels of performance for 
the same characteristics, FDA could find the new device as safe and 
effective as the legally marketed device. Instead of reviewing data 
from direct comparison testing between the two devices, FDA could 
support a finding of substantial equivalence with data demonstrating 
the new device meets the level of performance of an appropriate 
predicate device(s). Under this optional Safety and Performance Based 
Pathway, a submitter could satisfy the requirement to compare its 
device with a legally marketed device by, among other things, 
independently demonstrating that the device's performance meets 
performance criteria as established in the above-listed guidances, 
rather than using direct predicate comparison testing for some of the 
performance characteristics.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
---------------------------------------------------------------------------

    A notice of availability of the draft guidances appeared in the 
Federal Register of September 20, 2019 (84 FR 49528). FDA did not 
receive comments on the ``Cutaneous Electrode for Recording Purposes'' 
guidance; FDA considered comments received on the ``Conventional Foley 
Catheters'' guidance and revised the guidance as appropriate, including 
by clarifying, in the discussion of Biocompatibility Evaluation, when 
material mediated pyrogenicity testing is recommended.
    These guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidances represent 
the current thinking of FDA on performance criteria for the ``Cutaneous 
Electrode for Recording Purposes'' and ``Conventional Foley 
Catheters.'' They do not establish any rights for any person and are 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidances may do so 
by downloading an electronic copy from the internet. A search 
capability for all

[[Page 49657]]

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. These guidance documents are also 
available at https://www.regulations.gov. Persons unable to download an 
electronic copy of either ``Cutaneous Electrode for Recording 
Purposes--Performance Criteria for Safety and Performance Based 
Pathway; Guidance for Industry and Food and Drug Administration Staff 
(document number 19014)'' or ``Conventional Foley Catheters--
Performance Criteria for Safety and Performance Based Pathway; Guidance 
for Industry and Food and Drug Administration Staff (document number 
19010)'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    These guidances contains no collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, these guidances refer to previously approved collections 
of information. These collections of information are subject to review 
by OMB under the PRA. 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; guidance                Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
------------------------------------------------------------------------


    Dated: August 7, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17771 Filed 8-13-20; 8:45 am]
BILLING CODE 4164-01-P

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