2021-08992. Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 055  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 055” (Recognition List Number: 055), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

    DATES:

    Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable April 29, 2021.

    ADDRESSES:

    You may submit comments on the current list of FDA Recognized Consensus Standards at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://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 Start Printed Page 22679written/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-2004-N-0451 for “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 055.” 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. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 055.

    • 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.

    An electronic copy of Recognition List Number: 055 is available on the internet at https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm. See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 055 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 055” to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287, CDRHStandardsStaff@fda.hhs.gov.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    I. Background

    Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

    In the Federal Register of September 14, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The guidance describes how FDA has implemented its standards recognition program and is available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices. Modifications to the initial list of recognized standards, as published in the Federal Register , can be accessed at https://www.fda.gov/​medical-devices/​standards-and-conformity-assessment-program/​federal-register-documents.

    These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains on its website hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards, available at https://www.fda.gov/​medical-devices/​standards-and-conformity-assessment-program/​federal-register-documents. Additional information on the Agency's Standards and Conformity Assessment Program is available at https://www.fda.gov/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​standards-and-conformity-assessment-program.

    II. Modifications to the List of Recognized Standards, Recognition List Number: 055

    FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 055” to identify the current modifications.

    In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

    In section III, FDA lists modifications the Agency is making that involve new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 055.Start Printed Page 22680

    Table 1—Modifications to the List of Recognized Standards

    Old recognition No.Replacement recognition No.Title of standard 1Change
    A. Anesthesiology
    1-791-147ISO 26825 Second edition 2020-10 Anaesthetic and respiratory equipment—User-applied labels for syringes containing drugs used during anaesthesia—Colours, design and performanceWithdrawn and replaced with newer version.
    1-1021-148ISO 80601-2-69 Second edition 2020-11 Medical electrical equipment—Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipmentWithdrawn and replaced with newer version.
    1-1231-149ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment—Laryngoscopes for tracheal intubationWithdrawn and replaced with newer version.
    1-1251-150ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tractWithdrawn and replaced with newer version.
    1-146ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilatorsTransition period extended.
    B. Biocompatibility
    2-1192-277ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical DevicesWithdrawn and replaced with newer version.
    2-1222-278ASTM F719-20 ε1 Standard Practice for Testing Materials in Rabbits for Primary Skin IrritationWithdrawn and replaced with newer version.
    2-1242-279ASTM F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the MouseWithdrawn and replaced with newer version.
    2-1332-280ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant MaterialsWithdrawn and replaced with newer version.
    2-1672-281ISO 10993-19 Second edition 2020-03 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materialsWithdrawn and replaced with newer version.
    2-2052-282ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects—Good clinical practiceWithdrawn and replaced with newer version.
    2-2142-283ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical DevicesWithdrawn and replaced with newer version.
    2-2692-284USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version.
    2-2702-285USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version.
    2-2712-286USP 43-NF38:2020 <88> Biological Reactivity Tests, In VivoWithdrawn and replaced with newer version.
    2-2722-287USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version.
    C. Cardiovascular
    No new entries at this time.
    D. Dental/Ear, Nose, and Throat (ENT)
    4-924-264ANSI/ADA Standard No. 88—2019 Dental Brazing AlloysWithdrawn and replaced with newer version.
    4-243ISO 10271 First edition 2001-06 Dental metallic materials—Corrosion test methodsWithdrawn.
    4-2454-265ISO 10271 Third edition 2020-08 Dentistry—Corrosion test methods for metallic materialsWithdrawn and replaced with newer version.
    E. General I (Quality Systems/Risk Management) (QS/RM)
    5-765-131IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsWithdrawn and replaced with newer version.
    5-895-132IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: UsabilityWithdrawn and replaced with newer version.
    5-1155-133ISO 80369-7 Second edition 2021 Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applicationsWithdrawn and replaced with newer version.
    Start Printed Page 22681
    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
    19-819-36IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and testsWithdrawn and replaced with newer version.
    19-919-37IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-10: General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllersWithdrawn and replaced with newer version.
    19-1419-38IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentWithdrawn and replaced with newer version.
    19-1519-39IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environmentWithdrawn and replaced with newer version.
    G. General Hospital/General Plastic Surgery (GH/GPS)
    6-11ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment—Part 1: General requirementsWithdrawn. See 5-133.
    6-129ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment—Part 2: Lock fittingsWithdrawn. See 5-133.
    6-1806-448ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare FacilitiesWithdrawn and replaced with newer version.
    6-3396-449ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby CribsWithdrawn and replaced with newer version.
    6-340ASTM F2710-13 Standard Consumer Safety Performance Specification for Commercial CribsWithdrawn.
    6-3876-450IEC 60601-2-50 Ed. 3.0 2020-09 Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipmentWithdrawn and replaced with newer version.
    6-4286-451USP 43-NF38:2020 Sodium Chloride IrrigationWithdrawn and replaced with newer version.
    6-4296-452USP 43-NF38:2020 Sodium Chloride InjectionWithdrawn and replaced with newer version.
    6-4306-453USP 43-NF38:2020 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version.
    6-4316-454USP 43-NF38:2020 <881> Tensile StrengthWithdrawn and replaced with newer version.
    6-4326-455USP 43-NF38:2020 <861> Sutures—DiameterWithdrawn and replaced with newer version.
    6-4336-456USP 43-NF38:2020 <871> Sutures—Needle AttachmentWithdrawn and replaced with newer version.
    6-4346-457USP 43-NF38:2020 Sterile Water for IrrigationWithdrawn and replaced with newer version.
    6-4356-458USP 43-NF38:2020 Heparin Lock Flush SolutionWithdrawn and replaced with newer version.
    6-4366-459USP 43-NF38:2020 Absorbable Surgical SutureWithdrawn and replaced with newer version.
    H. In Vitro Diagnostics (IVD)
    7-101CLSI H51-A Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved GuidelineWithdrawn.
    7-1127-299CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation MonitoringWithdrawn and replaced with newer version.
    7-131CLSI I/LA18-A2 (Replaces I/LA18-A) Specifications for Immunological Testing for Infectious Diseases; Approved Guideline—Second EditionWithdrawn.
    7-135CLSI H44-A2 (Replaces H44-A) Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline—Second EditionWithdrawn.
    7-142CLSI GP43-A4 (Formerly H11-A4) Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth EditionWithdrawn.
    Start Printed Page 22682
    7-146CLSI M06-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second EditionWithdrawn.
    7-164CLSI GP28-A (Replaces GP28-P) Microwave Device Use in the Histology Laboratory; Approved GuidelineWithdrawn.
    7-173CLSI C44-A (Replaces C44-P) Harmonization of Glycohemoglobin Measurements; Approved GuidelineWithdrawn.
    7-1917-300CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular MethodsWithdrawn and replaced with newer version.
    7-2037-301CLSI GP42 7th Edition Collection of Capillary Blood SpecimensWithdrawn and replaced with newer version.
    7-2117-302CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride AnalysisWithdrawn and replaced with newer version.
    7-2177-303CLSI M60 2nd Edition Performance Standards for Antifungal Susceptibility Testing of YeastWithdrawn and replaced with newer version.
    7-2617-304CLSI M23 5th Edition Development of In Vitro Susceptibility Testing Criteria and Quality Control ParametersWithdrawn and replaced with newer version.
    I. Materials
    8-2178-537ASTM F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta ConditionWithdrawn and replaced with newer version.
    8-2238-538ASTM F2759-19 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal DevicesWithdrawn and replaced with newer version.
    8-3388-539ASTM F139-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Withdrawn and replaced with newer version.
    8-3398-540ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)Withdrawn and replaced with newer version.
    8-3428-541ASTM F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)Withdrawn and replaced with newer version.
    8-3488-542ASTM F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)Withdrawn and replaced with newer version.
    8-3618-543ASTM F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical ImplantsWithdrawn and replaced with newer version.
    8-3958-544ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)Withdrawn and replaced with newer version.
    8-4168-545ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical ImplantsWithdrawn and replaced with newer version.
    8-4178-546ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical ImplantsWithdrawn and replaced with newer version.
    8-4218-547ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical ImplantsWithdrawn and replaced with newer version.
    8-4388-548ISO/ASTM 52915 Third edition 2020-03 Specification for additive manufacturing file format (AMF) Version 1.2Withdrawn and replaced with newer version.
    8-5308-549ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical DevicesWithdrawn and replaced with newer version.
    J. Nanotechnology
    No new entries at this time.
    K. Neurology
    No new entries at this time.
    L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
    9-409-130ISO 8600-6: Second Edition 2020-09 Endoscopes—Medical endoscopes and endotherapy devices—Part 6: VocabularyWithdrawn and replaced with newer version.
    M. Ophthalmic
    10-4810-119ISO 11979-5 Third edition 2020-09 Ophthalmic implants—Intraocular Lenses—Part 5: BiocompatibilityWithdrawn and replaced with newer version.
    Start Printed Page 22683
    10-6310-120ISO/TR 22979 Second Edition 2017-05 Ophthalmic implants—Intraocular Lenses—Guidance on assessment of the need for clinical investigation of intraocular lens design modificationsWithdrawn and replaced with newer version.
    N. Orthopedic
    11-19111-370ISO 14879-1 Second edition 2020-07 Implants for surgery—Total knee-joint prostheses—Part 1: Determination of endurance properties of knee tibial traysWithdrawn and replaced with newer version.
    11-26711-371ASTM F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular ProsthesesWithdrawn and replaced with newer version.
    11-27911-372ASTM F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral StemsWithdrawn and replaced with newer version.
    11-28211-373ASTM F1223-20 Standard Test Method for Determination of Total Knee Replacement ConstraintWithdrawn and replaced with newer version.
    11-31311-374ISO 7207-2 Second edition 2011-07-01 Implants for surgery—Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]Withdrawn and replaced with newer version.
    11-330ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or DisassociationExtent of recognition.
    11-33211-375ASTM F2193-20 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal SystemWithdrawn and replaced with newer version.
    O. Physical Medicine
    No new entries at this time.
    P. Radiology
    No new entries at this time.
    Q. Software/Informatics
    No new entries at this time.
    R. Sterility
    14-31414-550ANSI/AAMI ST67:2019 Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”Withdrawn and replaced with newer version.
    14-36114-551ISO 14160 Third edition 2020-09 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesWithdrawn and replaced with newer version.
    14-41114-552ISO/ASTM 51818 Fourth edition 2020-06 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keVWithdrawn and replaced with newer version.
    14-49814-553ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical ProductsWithdrawn and replaced with newer version.
    14-51914-554ASTM F17-20 Standard Terminology Relating to Primary Barrier PackagingWithdrawn and replaced with newer version.
    14-53414-555USP 43-NF38:2020 <161> Medical Devices-Bacterial Endotoxin and Pyrogen TestsWithdrawn and replaced with newer version.
    14-53514-556USP 43-NF38:2020 <62> Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsWithdrawn and replaced with newer version.
    14-53614-557USP 43-NF38:2020 <55> Biological Indicators—Resistance Performance TestsWithdrawn and replaced with newer version.
    14-53714-558USP 43-NF38:2020 <1229.5> Biological Indicators for SterilizationWithdrawn and replaced with newer version.
    14-54614-559USP 43-NF38:2020 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version.
    14-54714-560USP 43-NF38:2020 <71> Sterility TestsWithdrawn and replaced with newer version.
    14-54814-561USP 43-NF38:2020 <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version.
    Start Printed Page 22684
    S. Tissue Engineering
    15-35ASTM F2900-11 Standard Guide for Characterization of Hydrogels used in Regenerative MedicineWithdrawn.
    15-36ASTM F2383-11 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)Withdrawn.
    15-38ASTM F2883-11 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant ApplicationsWithdrawn.
    15-4515-64ISO 22442-1 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk managementWithdrawn and replaced with newer version.
    15-4615-65ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handlingWithdrawn and replaced with newer version.
    1 All standard titles in this table conform to the style requirements of the respective organizations.

    III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 055. These entries are of standards not previously recognized by FDA.

    Table 2—New Entries to the List of Recognized Standards

    Recognition No.Title of standard 1Reference No. and date
    A. Anesthesiology
    No new entries at this time.
    B. Biocompatibility
    2-288Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloysISO 10993-15 Second edition 2019-11.
    C. Cardiovascular
    3-169Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillatorsIEC Edition 3.1 2018-02 CONSOLIDATED VERSION.
    D. Dental/Ear, Nose, and Throat (ENT)
    4-266Dentistry—Orthodontic anchor screwsISO 19023 First edition 2018-02.
    4-267Dentistry—Elastomeric auxiliaries for use in orthodonticsISO 21606 First edition 2007-06.
    4-268Dentistry—Wires for use in orthodontics [Including AMENDMENT 1 (2020)]ISO 15841 Second edition 2014-08.
    4-269Dentistry—Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]ISO 3964 Third edition 11-2016.
    4-270CAD/CAM Abutments in DentistryADA Technical Report No. 146-2018.
    4-271Dental Cartridge SyringesANSI/ADA Standard No. 34-2013.
    4-272Root Canal Barbed Broaches and Rasps.ANSI/ADA Standard No. 63-2013.
    E. General I (Quality Systems/Risk Management) (QS/RM)
    No new entries at this time.
    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
    No new entries at this time.
    G. General Hospital/General Plastic Surgery (GH/GPS)
    No new entries at this time.
    H. In Vitro Diagnostics (IVD)
    7-305In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.ISO 17511 Second edition 2020-04.
    Start Printed Page 22685
    I. Materials
    8-550Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical ImplantsASTM F2181-20.
    8-551Standard Practice for Digital Radiography of Cast Metallic ImplantsASTM F2895-20.
    8-552Guide for Additive manufacturing—Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing New publicationASTM F3434-20.
    8-553Additive manufacturing—Material extrusion-based additive manufacturing of plastic materials—Part 1: Feedstock materialsISO/ASTM 52903-1 First edition 2020-04.
    8-554Additive manufacturing—Design—Functionally graded additive manufacturingISO/ASTM TR 52912 First edition 2020-09.
    J. Nanotechnology
    18-17Nanotechnologies—Measurements of particle size and shape distributions by transmission electron microscopyISO 21363 First edition 2020-06.
    18-18Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light ScatteringASTM E3247-20.
    K. Neurology
    17-17Standard Specification for Neurosurgical Head Holder DevicesASTM F3395/F3395M-19.
    L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
    No new entries at this time.
    M. Ophthalmic
    10-121Ophthalmic implants—Ocular endotamponadesISO 16672 Third edition 2020-06.
    N. Orthopedic
    No new entries at this time.
    O. Physical Medicine
    16-230American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered WheelchairsANSI/RESNA WC-2:2019 Section 25.
    P. Radiology
    No new entries at this time.
    Q. Software/Informatics
    13-116Common Vulnerability Scoring System version 3.0FIRST CVSS v3.0.
    R. Sterility
    No new entries at this time.
    S. Tissue Engineering
    No new entries at this time.
    1 All standard titles in this table conform to the style requirements of the respective organizations.

    IV. List of Recognized Standards

    IV. List of Recognized Standards

    FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfStandards/​search.cfm. Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet appeared in the Federal Register). FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary.

    V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the Start Printed Page 22686recommendation, to CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations should contain, at a minimum, the information available at https://www.fda.gov/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​standards-and-conformity-assessment-program#process.

    Start Signature

    Dated: April 23, 2021.

    Lauren K. Roth,

    Acting Principal Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2021-08992 Filed 4-28-21; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
04/29/2021
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2021-08992
Dates:
Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable April 29, 2021.
Pages:
22678-22686 (9 pages)
Docket Numbers:
Docket No. FDA-2004-N-0451
PDF File:
2021-08992.pdf
Supporting Documents:
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 058
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 056
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 054
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 053
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 052
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 043
» Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 041