The Accreditation Scheme for Conformity Assessment Program; Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability, 77526-77528 [2024-21673]

Download as PDF 77526 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 1. ‘‘PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027’’ at https://www.fda.gov/media/151712/ download. 2. FDA guidance for industry ‘‘Expedited Programs for Serious Conditions—Drugs and Biologics’’ (May 2014): https://www.fda.gov/media/ 86377/download. 3. FDA guidance for industry ‘‘Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications’’ (Rev. 7) (February 2020): https://www.fda.gov/media/ 135373/download. 4. FDA guidance for industry ‘‘Process Validation: General Principles and Practices’’ (Rev. 1) (January 2011): https://www.fda.gov/files/drugs/ published/Process-Validation-GeneralPrinciples-and-Practices.pdf. 5. CDER MAPP 5015.13: ‘‘Quality Assessment for Products in Expedited Programs’’ (December 2022): https:// www.fda.gov/media/162786/ download?attachment. 6. FDA draft guidance for industry ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products’’ (Rev. 1) (September 2023): https://www.fda.gov/media/172311/ download. 7. CDER MAPP 6025.6: ‘‘Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics’’ (Rev. 1) (February 2024): https://www.fda.gov/media/89155/ download. 8. CBER ‘‘SOPP 8101.1: Regulatory Meetings With Sponsors and Applicants for Drugs and Biological Products’’ (March 2023). 9. CBER ‘‘SOPP 8212: Breakthrough Therapy Products—Designation and Management’’ (August 2023). Dated: September 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–21674 Filed 9–20–24; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–3805] The Accreditation Scheme for Conformity Assessment Program; Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidance documents for the Accreditation Scheme for Conformity Assessment Program entitled ‘‘The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;’’ ‘‘Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment— Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;’’ and ‘‘Biocompatibility Testing of Medical Devices—Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff.’’ In accordance with amendments made by the FDA User Fee Reauthorization Act of 2022 (FUFRA), part of the Medical Device User Fee Amendments of 2022 (MDUFA V), FDA was directed to conclude the Pilot Accreditation Scheme for Conformity Assessment Program by the end of fiscal year 2023 and continue to operate the program (hereafter referred to as the ASCA Program) consistent with the amended FD&C Act. FDA is publishing these draft guidance documents which, when finalized, are intended to provide updates to improve the ASCA Program. These draft guidance documents are not final nor for implementation at this time. SUMMARY: Submit either electronic or written comments on the draft guidance by November 22, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. DATES: VerDate Sep<11>2014 16:57 Sep 20, 2024 Jkt 262001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 You may submit comments on any guidance at any time as follows: ADDRESSES: 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– 2019–D–3805 for ‘‘The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;’’ ‘‘Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment—Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;’’ and ‘‘Biocompatibility Testing of Medical Devices—Standards Specific Information for the Accreditation E:\FR\FM\23SEN1.SGM 23SEN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff.’’ 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, 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-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)). Electronic copies of these three guidance documents are available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidances. Submit written requests for single hard copies of the draft guidance documents entitled ‘‘The Accreditation VerDate Sep<11>2014 16:57 Sep 20, 2024 Jkt 262001 Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff’’; ‘‘Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment—Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff’’; and ‘‘Biocompatibility Testing of Medical Devices—Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff’’ to the Office of Policy, 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. Eric Franca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5500, Silver Spring, MD 20993–0002, 301–796–4505, ASCA@fda.hhs.gov; or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402–7911. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background FDA has concluded the ASCA pilot phase and is establishing an ongoing ASCA Program, in accordance with amendments made to section 514 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d) by section 2005 of the FDA User Fee Reauthorization Act of 2022, part of the Medical Device User Fee Amendments of 2022. The three final ASCA Pilot guidance documents issued on September 25, 2020, are also being updated to make improvements to the ASCA Program based on lessons learned during ASCA’s pilot phase and to convey the commitments stipulated in MDUFA V. These draft guidance updates incorporate feedback received through public meetings and webinars, the docket, stakeholder meetings, communications with participating accreditation bodies and testing laboratories, and lessons learned internally from review staff and ASCA staff during the pilot phase. The updates will also allow FDA to appropriately PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 77527 expand ASCA per MDUFA V commitments and expectations. These draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidances, when finalized, will represent the current thinking of FDA on the ASCA Program. 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. II. 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. Persons unable to download an electronic copy of ‘‘The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;’’ ‘‘Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment—Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;’’ and ‘‘Biocompatibility Testing of Medical Devices—Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document numbers GUI00017037, GUI00020011, and/or GUI00020012, respectively, and complete title(s) to identify the guidance(s) you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of E:\FR\FM\23SEN1.SGM 23SEN1 77528 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of OMB Control No. 21 CFR part; guidance; or FDA form Topic ‘‘The Accreditation Scheme for Conformity Assessment (ASCA) Program’’. 807, subpart E .................................................................... 814, subparts A through E ................................................. 814, subpart H .................................................................... 812 ...................................................................................... 860, subpart D .................................................................... ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. 803 ...................................................................................... ASCA Program ..................................................................................... 0910–0889 Premarket notification ........................................................................... Premarket approval .............................................................................. Humanitarian Device Exemption .......................................................... Investigational Device Exemption ........................................................ De Novo classification process ............................................................ Q-submissions ...................................................................................... 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0756 Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies. 0910–0437 820 ...................................................................................... 58 ........................................................................................ Dated: September 18, 2024. Lauren K. Roth, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–2583] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by October 23, 2024. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0858. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. ADDRESSES: [FR Doc. 2024–21673 Filed 9–20–24; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES information in the following table have been approved by OMB: Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act 0910–0073 0910–0119 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a and 21 U.S.C. 353b), which govern compounding by pharmacies, outsourcing facilities, and other entities. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present risks to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them. Respondents to the information collection are pharmacies, outsourcing facilities, and other entities. To assist respondents in complying with statutory requirements, we have issued the following topic-specific guidance documents: OMB Control Number 0910–0858— Extension This information collection helps support implementation of sections TABLE 1—PUBLISHED GUIDANCE DOCUMENTS REGARDING SECTIONS 503A AND 503B OF THE FD&C ACT Title Notice of availability publication date Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities (Radiopharmaceutical Compounding and Repackaging Guidance) (available at https://www.fda.gov/media/102615/download). VerDate Sep<11>2014 16:57 Sep 20, 2024 Jkt 262001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM September 26, 2018 (83 FR 48633). 23SEN1

Agencies

[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77526-77528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21673]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3805]


The Accreditation Scheme for Conformity Assessment Program; Draft 
Guidances for Industry, Accreditation Bodies, Testing Laboratories, 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 three draft guidance documents for the 
Accreditation Scheme for Conformity Assessment Program entitled ``The 
Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance 
for Industry, Accreditation Bodies, Testing Laboratories, and FDA 
Staff;'' ``Basic Safety and Essential Performance of Medical Electrical 
Equipment, Medical Electrical Systems, and Laboratory Medical 
Equipment--Standards Specific Information for the Accreditation Scheme 
for Conformity Assessment (ASCA) Program: Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and FDA Staff;'' and 
``Biocompatibility Testing of Medical Devices--Standards Specific 
Information for the Accreditation Scheme for Conformity Assessment 
(ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and FDA Staff.'' In accordance with amendments made by 
the FDA User Fee Reauthorization Act of 2022 (FUFRA), part of the 
Medical Device User Fee Amendments of 2022 (MDUFA V), FDA was directed 
to conclude the Pilot Accreditation Scheme for Conformity Assessment 
Program by the end of fiscal year 2023 and continue to operate the 
program (hereafter referred to as the ASCA Program) consistent with the 
amended FD&C Act. FDA is publishing these draft guidance documents 
which, when finalized, are intended to provide updates to improve the 
ASCA Program. These draft guidance documents are not final nor for 
implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by November 22, 2024 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-2019-D-3805 for ``The Accreditation Scheme for Conformity 
Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff;'' ``Basic Safety and Essential 
Performance of Medical Electrical Equipment, Medical Electrical 
Systems, and Laboratory Medical Equipment--Standards Specific 
Information for the Accreditation Scheme for Conformity Assessment 
(ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and FDA Staff;'' and ``Biocompatibility Testing of 
Medical Devices--Standards Specific Information for the Accreditation

[[Page 77527]]

Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and FDA Staff.'' 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, 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)).
    Electronic copies of these three guidance documents are available 
for download from the internet. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidances. Submit 
written requests for single hard copies of the draft guidance documents 
entitled ``The Accreditation Scheme for Conformity Assessment (ASCA) 
Program; Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and FDA Staff''; ``Basic Safety and Essential Performance 
of Medical Electrical Equipment, Medical Electrical Systems, and 
Laboratory Medical Equipment--Standards Specific Information for the 
Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance 
for Industry, Accreditation Bodies, Testing Laboratories, and FDA 
Staff''; and ``Biocompatibility Testing of Medical Devices--Standards 
Specific Information for the Accreditation Scheme for Conformity 
Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, 
Testing Laboratories, and FDA Staff'' to the Office of Policy, 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: Eric Franca, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5500, Silver Spring, MD 20993-0002, 301-796-4505, 
[email protected]; or James Myers, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has concluded the ASCA pilot phase and is establishing an 
ongoing ASCA Program, in accordance with amendments made to section 514 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d) by section 
2005 of the FDA User Fee Reauthorization Act of 2022, part of the 
Medical Device User Fee Amendments of 2022. The three final ASCA Pilot 
guidance documents issued on September 25, 2020, are also being updated 
to make improvements to the ASCA Program based on lessons learned 
during ASCA's pilot phase and to convey the commitments stipulated in 
MDUFA V. These draft guidance updates incorporate feedback received 
through public meetings and webinars, the docket, stakeholder meetings, 
communications with participating accreditation bodies and testing 
laboratories, and lessons learned internally from review staff and ASCA 
staff during the pilot phase. The updates will also allow FDA to 
appropriately expand ASCA per MDUFA V commitments and expectations.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidances, 
when finalized, will represent the current thinking of FDA on the ASCA 
Program. 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.

II. 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``The Accreditation Scheme for Conformity Assessment (ASCA) Program; 
Guidance for Industry, Accreditation Bodies, Testing Laboratories, and 
FDA Staff;'' ``Basic Safety and Essential Performance of Medical 
Electrical Equipment, Medical Electrical Systems, and Laboratory 
Medical Equipment--Standards Specific Information for the Accreditation 
Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, 
Accreditation Bodies, Testing Laboratories, and FDA Staff;'' and 
``Biocompatibility Testing of Medical Devices--Standards Specific 
Information for the Accreditation Scheme for Conformity Assessment 
(ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing 
Laboratories, and FDA Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document numbers GUI00017037, GUI00020011, and/or 
GUI00020012, respectively, and complete title(s) to identify the 
guidance(s) you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of

[[Page 77528]]

information. The previously approved collections of information are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction act of 1995 (PRA) (44 U.S.C. 3501-3521). The 
collections of information in the following table have been approved by 
OMB:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB  Control
             form                          Topic                 No.
------------------------------------------------------------------------
``The Accreditation Scheme for  ASCA Program..............     0910-0889
 Conformity Assessment (ASCA)
 Program''.
807, subpart E................  Premarket notification....     0910-0120
814, subparts A through E.....  Premarket approval........     0910-0231
814, subpart H................  Humanitarian Device            0910-0332
                                 Exemption.
812...........................  Investigational Device         0910-0078
                                 Exemption.
860, subpart D................  De Novo classification         0910-0844
                                 process.
``Requests for Feedback and     Q-submissions.............     0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
803...........................  Medical Devices; Medical       0910-0437
                                 Device Reporting;
                                 Manufacturer reporting,
                                 importer reporting, user
                                 facility reporting,
                                 distributor reporting.
820...........................  Current Good Manufacturing     0910-0073
                                 Practice (CGMP); Quality
                                 System (QS) Regulation.
58............................  Good Laboratory Practice       0910-0119
                                 (GLP) Regulations for
                                 Nonclinical Laboratory
                                 Studies.
------------------------------------------------------------------------


    Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21673 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P
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