Document ID: FDA-2004-N-0451-0045
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051
Posted Date: 2019-03-14T04:00Z

[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9354-9362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04710]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 051

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: 051'' (Recognition List Number: 051), 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 March 14, 2019.

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: 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-2004-N-0451 for ``Food and Drug Administration Modernization Act of 
1997: Modifications to the List of Recognized Standards, Recognition 
List Number: 051.'' 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. 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: 051.
     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: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    An electronic copy of Recognition List Number: 051 is available on 
the internet

[[Page 9355]]

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: 051 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: 051'' to Scott 
Colburn (see FOR FURTHER INFORMATION CONTACT). Send one self-addressed 
adhesive label to assist that office in processing your request or Fax 
your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, 
CDRHStandardsStaff@fda.hhs.gov.

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 standard 
recognition program and is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. Modifications to the initial list of recognized 
standards, as published in the Federal Register, can be accessed at 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains hypertext 
markup language (HTML) and portable document format (PDF) versions of 
the list of FDA Recognized Consensus Standards. Additional information 
on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 051

    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: 051'' 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 the initial addition of standards not previously recognized by 
FDA.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                       Replacement
        Old recognition No.            recognition           Title of standard \1\               Change \2\
                                           No.
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-104..............................           1-141  ISO 80601-2-13 First edition 2011-08- Withdrawn and
                                                      11 Medical electrical equipment--     replaced with newer
                                                      Part 2-13: Particular requirements    version including
                                                      for basic safety and essential        amendment. Extent of
                                                      performance of an anaesthetic         Recognition.
                                                      workstation [Including: AMENDMENT 1
                                                      (2015) and AMENDMENT 2 (2018)].
1-108..............................  ..............  ANSI/AAMI/ISO 5361:2012 Anaesthetic   Withdrawn. See 1-118.
                                                      and respiratory equipment--Tracheal
                                                      tubes and connectors.
1-110..............................  ..............  ANSI/AAMI/ISO 5366-1:2000             Withdrawn. See 1-117.
                                                      Anaesthetic and respiratory
                                                      equipment--Tracheostomy tubes--Part
                                                      1: Tubes and connectors for use in
                                                      adults.
1-111..............................  ..............  ANSI/AAMI/ISO 5366-3:2001             Withdrawn. See 1-117.
                                                      Anaesthetic and respiratory
                                                      equipment--Tracheostomy Tubes--Part
                                                      3: Paediatric Tracheostomy Tubes.
1-114..............................  ..............  ISO 18835 First Edition 2015-04-01    Extent of
                                                      Inhalational Anaesthesia Systems--    Recognition.
                                                      Draw-over Anaesthetic Systems.
1-117..............................  ..............  ISO 5366 First edition 2016-10-01     Extent of
                                                      Anaesthetic and respiratory           Recognition.
                                                      equipment--Tracheostomy tubes and
                                                      connectors.
1-118..............................  ..............  ISO 5361 Third edition 2016-09-01     Extent of
                                                      Anaesthetic and respiratory           Recognition.
                                                      equipment--Tracheal tubes and
                                                      connectors.
1-120..............................  ..............  ISO 18190 First edition 2016-11-01    Extent of
                                                      Anaesthetic and respiratory           Recognition.
                                                      equipment--General requirements for
                                                      airways and related equipment.
1-138..............................  ..............  ISO 80601-2-74 First edition 2017-05  Extent of
                                                      Medical electrical equipment--Part    Recognition.
                                                      2-74: Particular requirements for
                                                      basic safety and essential
                                                      performance of respiratory
                                                      humidifying equipment.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-136..............................  ..............  ASTM E1262-88 (Reapproved 2018)       Reaffirmation.
                                                      Standard Guide for Performance of
                                                      Chinese Hamster Ovary Cell/
                                                      Hypoxanthine Guanine Phosphoribosyl
                                                      Transferase Gene Mutation Assay.
2-141..............................  ..............  ASTM F1984-99 (Reapproved 2018)       Reaffirmation.
                                                      Standard Practice for Testing for
                                                      Whole Complement Activation in
                                                      Serum by Solid Materials.

[[Page 9356]]

 
2-145..............................  ..............  ASTM F1439-03 (Reapproved 2018)       Reaffirmation.
                                                      Standard Guide for Performance of
                                                      Lifetime Bioassay for the
                                                      Tumorigenic Potential of Implant
                                                      Materials.
2-220..............................           2-258  ISO 10993-1 Fifth edition 2018-08     Withdrawn and
                                                      Biological evaluation of medical      replaced with newer
                                                      devices--Part 1: Evaluation and       version.
                                                      testing within a risk management
                                                      process.
2-251..............................           2-259  USP 41-NF36:2018 <87> Biological      Withdrawn and
                                                      Reactivity Test, In Vitro--Direct     replaced with newer
                                                      Contact Test.                         version.
2-252..............................           2-260  USP 41-NF36:2018 <87> Biological      Withdrawn and
                                                      Reactivity Test, In Vitro--Elution    replaced with newer
                                                      Test.                                 version.
2-253..............................           2-261  USP 41-NF36:2018 <88> Biological      Withdrawn and
                                                      Reactivity Test, In Vivo.             replaced with newer
                                                                                            version.
2-254..............................           2-262  USP 41-NF36:2018 <151> Pyrogen Test   Withdrawn and
                                                      (USP Rabbit Test).                    replaced with newer
                                                                                            version. Extent of
                                                                                            Recognition.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-44...............................  ..............  AAMI BP22:1994 (R2016) Blood          Reaffirmation.
                                                      Pressure Transducers.
3-52...............................  ..............  ANSI/AAMI EC12:2000/(R) 2015          Reaffirmation.
                                                      Disposable ECG electrodes.
3-55...............................  ..............  ASTM F1830-97 (Reapproved 2017)       Reaffirmation.
                                                      Standard Practice for Selection of
                                                      Blood for in vitro Evaluation of
                                                      Blood Pumps.
3-56...............................  ..............  ASTM F1841-97 (Reapproved 2017)       Reaffirmation. Extent
                                                      Standard Practice for Assessment of   of Recognition.
                                                      Hemolysis in Continuous Flow Blood
                                                      Pumps.
3-66...............................  ..............  ASTM F2081-06 (Reapproved 2017)       Reaffirmation.
                                                      Standard Guide for Characterization
                                                      and Presentation of the Dimensional
                                                      Attributes of Vascular Stents.
3-79...............................  ..............  ASTM F2079-09 (Reapproved 2017)       Reaffirmation.
                                                      Standard Test Method for Measuring
                                                      Intrinsic Elastic Recoil of Balloon-
                                                      Expandable Stents.
3-86...............................  ..............  ASTM F2394-07 (Reapproved 2017)       Reaffirmation. Extent
                                                      Standard Guide for Measuring          of Recognition.
                                                      Securement of Balloon Expandable
                                                      Vascular Stent Mounted on Delivery
                                                      System.
3-99...............................  ..............  AAMI TIR 42:2010 Evaluation of        Extent of
                                                      Particulates Associated with          Recognition.
                                                      Vascular Medical Devices.
3-122..............................  ..............  IEC 81060-2 Second edition 2013-05-   Extent of
                                                      01 Non-invasive sphygmomanometers--   Recognition.
                                                      Part 2: Clinical validation of
                                                      automated measurement type.
3-123..............................  ..............  IEC 80601-2-30 Edition 2.0 2018-03    Title change. Extent
                                                      Medical electrical equipment--Part    of recognition.
                                                      2-30: Particular requirements for
                                                      the basic safety and essential
                                                      performance of automated non-
                                                      invasive sphygmomanometers.
3-124..............................  ..............  ISO 7199:2009 Cardiovascular          Withdrawn.
                                                      implants and artificial organs--
                                                      Blood gas exchangers (oxygenators).
3-126..............................  ..............  IEC 60601-2-27 Edition 3.0 2011-03    Extent of
                                                      Medical electrical equipment--Part    recognition.
                                                      2-27: Particular requirements for
                                                      the basic safety and essential
                                                      performance of electrocardiographic
                                                      monitoring equipment.
3-127..............................  ..............  ANSI/AAMI/IEC 60601-2-47:2012/(R)     Reaffirmation.
                                                      2016 Medical electrical equipment--
                                                      Part 2-47: Particular requirements
                                                      for the basic safety and essential
                                                      performance of ambulatory
                                                      electrocardiographic systems.
3-138..............................  ..............  ASTM F2942-13 Standard Guide for the  Extent of
                                                      In Vitro Axial, Bending, and          Recognition.
                                                      Rotational Durability Test of
                                                      Vascular Stents.
3-142..............................  ..............  ISO/TS 17137 First edition 2014-05-   Extent of
                                                      15 Cardiovascular implants and        Recognition.
                                                      extracorporeal systems--
                                                      Cardiovascular absorbable implants.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-126..............................           4-248  ISO 10477 Third edition 2018-06       Withdrawn and
                                                      Dentistry--Polymer-based crown and    replaced with newer
                                                      veneering materials.                  version.
4-150..............................           4-249  ANSI/ADA Standard No. 19--2018        Withdrawn and
                                                      Elastomeric Impression Materials.     replaced with newer
                                                                                            version.
4-162..............................  ..............  ANSI S3.4-2007 (Reaffirmed 2017)      Reaffirmation.
                                                      American National Standard
                                                      Procedure for the Computation of
                                                      Loudness of Steady Sounds.
4-163..............................  ..............  ANSI S3.5-1997 (Reaffirmed 2017)      Reaffirmation.
                                                      American National Standard Methods
                                                      for Calculation of the Speech
                                                      Intelligibility Index.
4-171..............................  ..............  ANSI S3.37-1987 (Reaffirmed 2017)     Reaffirmation.
                                                      American National Standard
                                                      Preferred Earhook Nozzle Thread for
                                                      Postauricular Hearing Aids.
4-213..............................           4-250  ISO 7494-1 Third edition 2018-06      Withdrawn and
                                                      Dentistry--Stationary dental units    replaced with newer
                                                      and dental patient chairs--Part 1:    version.
                                                      General requirements.
4-217..............................  ..............  ANSI/ASA S3.36-2012 (Reaffirmed       Reaffirmation.
                                                      2018) American National Standard
                                                      Specification for a Manikin for
                                                      Simulated in-situ Airborne Acoustic
                                                      Measurements.
4-223..............................           4-251  ISO 6872 Fourth edition 2015-06-01    Withdrawn and
                                                      Dentistry--Ceramic materials          replaced with newer
                                                      [including AMENDMENT 1 2018-04].      version including
                                                                                            amendment.
4-226..............................           4-252  ISO 10650 Second edition 2018-08      Withdrawn and
                                                      Dentistry--Powered polymerization     replaced with newer
                                                      activators.                           version.
----------------------------------------------------------------------------------------------------------------

[[Page 9357]]

 
                             E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-39...............................           5-120  IEC 60812 Edition 3.0 2018-08         Withdrawn and
                                                      Failure modes and effects analysis    replaced with newer
                                                      (FMEA and FMECA).                     version. Title
                                                                                            change.
5-63...............................           5-121  ISO 80369-1 Second edition 2018-11    Withdrawn and
                                                      Small-bore connectors for liquids     replaced with newer
                                                      and gases in healthcare               version.
                                                      applications--Part 1: General
                                                      requirements.
5-105..............................  ..............  ISO 16142-1 First edition 2016-03-01  Withdrawn.
                                                      Medical devices--Recognized
                                                      essential principles of safety and
                                                      performance of medical devices--
                                                      Part 1: General essential
                                                      principles and additional specific
                                                      essential principles for all non-
                                                      IVD medical devices and guidance on
                                                      selection of standards.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-13..............................           19-32  IEC 62133-1 Edition 1.0 2017-02       Withdrawn and
                                                      Secondary cells and batteries         replaced with newer
                                                      containing alkaline or other non-     version. Title
                                                      acid electrolytes--Safety             change.
                                                      requirements for portable sealed
                                                      secondary cells, and for batteries
                                                      made from them, for use in portable
                                                      applications--Part 1: Nickel
                                                      systems.
                                              19-33  IEC 62133-2 Edition 1.0 2017-02
                                                      Secondary cells and batteries
                                                      containing alkaline or other non-
                                                      acid electrolytes--Safety
                                                      requirements for portable sealed
                                                      secondary cells, and for batteries
                                                      made from them, for use in portable
                                                      applications--Part 2: Lithium
                                                      systems.
19-18..............................           19-34  IEC 61010-1 Edition 3.1 2017-01       Withdrawn and
                                                      Safety requirements for electrical    replaced with newer
                                                      equipment for measurement, control,   version.
                                                      and laboratory use--Part 1: General
                                                      requirements.
----------------------------------------------------------------------------------------------------------------
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-239..............................           6-410  ISO 8536-6 Third edition 2016-12-01   Withdrawn and
                                                      Infusion equipment for medical use--  replaced with newer
                                                      Part 6: Freeze drying closures for    version.
                                                      infusion bottles.
6-338..............................  ..............  ASTM D7866-14 Standard Specification  Extent of
                                                      for Radiation Attenuating             recognition.
                                                      Protective Gloves.
6-383..............................           6-411  ASTM D6499-18 Standard Test Method    Withdrawn and
                                                      for Immunological Measurement of      replaced with newer
                                                      Antigenic Protein in Hevea Natural    version.
                                                      Rubber (HNR) and its Products.
6-391..............................           6-412  USP 41-NF36:2018 Sodium Chloride      Withdrawn and
                                                      Irrigation.                           replaced with newer
                                                                                            version.
6-392..............................           6-413  USP 41-NF36:2018 Sodium Chloride      Withdrawn and
                                                      Injection.                            replaced with newer
                                                                                            version.
6-393..............................           6-414  USP 41-NF36:2018 Nonabsorbable        Withdrawn and
                                                      Surgical Suture.                      replaced with newer
                                                                                            version.
6-394..............................           6-415  USP 41-NF36:2018 <881> Tensile        Withdrawn and
                                                      Strength.                             replaced with newer
                                                                                            version.
6-395..............................           6-416  USP 41-NF36:2018 <861> Sutures--      Withdrawn and
                                                      Diameter.                             replaced with newer
                                                                                            version.
6-396..............................           6-417  USP 41-NF36:2018 <871> Sutures--      Withdrawn and
                                                      Needle Attachment.                    replaced with newer
                                                                                            version.
6-397..............................           6-418  USP 41-NF36:2018 Sterile Water for    Withdrawn and
                                                      Irrigation.                           replaced with newer
                                                                                            version.
6-398..............................           6-419  USP 41-NF36:2018 Heparin Lock Flush   Withdrawn and
                                                      Solution.                             replaced with newer
                                                                                            version.
6-399..............................           6-420  USP 41-NF36: 2018 Absorbable          Withdrawn and
                                                      Surgical Suture.                      replaced with newer
                                                                                            version.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-139..............................  ..............  CLSI QMS24 3rd Edition September      Title change.
                                                      2016 Replaces GP27-A2 and GP29-A2.
                                                      Using Proficiency Testing and
                                                      Alternative Assessment to Improve
                                                      Medical Laboratory Quality.
7-178..............................  ..............  CLSI M22-A3 Vol. 24 No. 19 Replaces   Extent of
                                                      M22-A2 Vol. 16 No. 16 Quality         recognition.
                                                      Control for Commercially Prepared
                                                      Microbiological Culture Media;
                                                      Approved Standard--Third Edition.
7-200..............................           7-285  CLSI M48 2nd Edition Laboratory       Withdrawn and
                                                      Detection and Identification of       replaced with a
                                                      Mycobacteria.                         newer version.
7-215..............................  ..............  CLSI M44-A2 Vol. 29 No. 17 Replaces   Extent of
                                                      MM44-A Vol. 24 No. 15 Method for      recognition.
                                                      Antifungal Disk Diffusion
                                                      Susceptibility Testing of Yeast;
                                                      Approved Guideline--Second Edition.
7-222..............................  ..............  CLSI M24-A2 (Replaces M24-A)          Extent of
                                                      Susceptibility Testing of             recognition.
                                                      Mycobacteria, Nocardiae and other
                                                      Aerobic Actinomycetes; Approved
                                                      Standards--Second Edition.

[[Page 9358]]

 
7-228..............................           7-286  CLSI M11 9th Edition Methods for      Withdrawn and
                                                      Antimicrobial Susceptibility          replaced with a
                                                      Testing of Anaerobic Bacteria.        newer version.
                                                                                            Extent of
                                                                                            recognition.
7-232..............................  ..............  CLSI MM05-A2 Vol. 32 No. 6 Replaces   Extent of
                                                      MM05-A Vol. 23 No. 17 Nucleic Acid    recognition.
                                                      Amplification Assays for Molecular
                                                      Hematopathology; Approved
                                                      Guideline--Second Edition.
7-262..............................  ..............  CLSI M45 3rd Edition Methods for      Extent of
                                                      Antimicrobial Dilution and Disk       recognition.
                                                      Susceptibility Testing of
                                                      Infrequently Isolated or Fastidious
                                                      Bacteria.
7-269..............................  ..............  CLSI MM23 1st Edition Molecular       Extent of
                                                      Diagnostic Methods for Solid Tumors   recognition.
                                                      (Nonhematological Neoplasms).
7-282..............................  ..............  CLSI M60 1st Edition Performance      Withdrawn. Duplicate
                                                      Standards for Antifungal              version.
                                                      Susceptibility Testing of Yeasts.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-179..............................  ..............  ASTM F754-08 (Reapproved 2015)        Extent of
                                                      Standard Specification for            recognition.
                                                      Implantable Polytetrafluoroethylene
                                                      (PTFE) Sheet, Tube, and Rod Shapes
                                                      Fabricated from Granular Molding
                                                      Powders.
8-335..............................           8-480  ASTM F2063-18 Standard Specification  Withdrawn and
                                                      for Wrought Nickel-Titanium Shape     replaced with newer
                                                      Memory Alloys for Medical Devices     version.
                                                      and Surgical Implants.
8-345..............................           8-481  ASTM F1314-18 Standard Specification  Withdrawn and
                                                      for Wrought Nitrogen Strengthened     replaced with newer
                                                      22 Chromium--13 Nickel--5             version.
                                                      Manganese--2.5 Molybdenum Stainless
                                                      Steel Alloy Bar and Wire for
                                                      Surgical Implants (UNS S20910).
8-365..............................           8-482  ASTM D1505-18 Standard Test Method    Withdrawn and
                                                      for Density of Plastics by the        replaced with newer
                                                      Density-Gradient Technique.           version.
8-371..............................           8-483  ASTM F601-18 Standard Practice for    Withdrawn and
                                                      Fluorescent Penetrant Inspection of   replaced with newer
                                                      Metallic Surgical Implants.           version.
8-375..............................           8-484  ASTM F2066-18 Standard Specification  Withdrawn and
                                                      for Wrought Titanium-15 Molybdenum    replaced with newer
                                                      Alloy for Surgical Implant            version.
                                                      Applications (UNS R58150).
8-462..............................           8-485  ASTM F3260-18 Standard Test Method    Withdrawn and
                                                      for Determining the Flexural          replaced with newer
                                                      Stiffness of Medical Textiles.        version.
----------------------------------------------------------------------------------------------------------------
                                                J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-2...............................  ..............  ASTM E2535-07 (Reapproved 2018)       Reaffirmation.
                                                      Standard Guide for Handling Unbound
                                                      Engineered Nanoscale Particles in
                                                      Occupational Settings.
18-5...............................  ..............  ASTM E2859-11 (Reapproved 2017)       Reaffirmation.
                                                      Standard Guide for Size Measurement
                                                      of Nanoparticles Using Atomic Force
                                                      Microscopy.
18-6...............................  ..............  ASTM E2865-12 (Reapproved 2018)       Reaffirmation.
                                                      Standard Guide for Measurement of
                                                      Electrophoretic Mobility and Zeta
                                                      Potential of Nanosized Biological
                                                      Materials.
18-7...............................  ..............  ASTM E2834-12 (Reapproved 2018)       Reaffirmation.
                                                      Standard Guide for Measurement of
                                                      Particle Size Distribution of
                                                      Nanomaterials in Suspension by
                                                      Nanoparticle Tracking Analysis
                                                      (NTA).
18-8...............................  ..............  ASTM E2578-07 (Reapproved 2018)       Reaffirmation.
                                                      Standard Practice for Calculation
                                                      of Mean Sizes/Diameters and
                                                      Standard Deviations of Particle
                                                      Size Distributions.
----------------------------------------------------------------------------------------------------------------
                                                  K. Neurology
----------------------------------------------------------------------------------------------------------------
17-14..............................  ..............  ANSI/AAMI NS4:2013/(R) 2017           Reaffirmation.
                                                      Transcutaneous electrical nerve
                                                      stimulators.
----------------------------------------------------------------------------------------------------------------
                      L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-68...............................  ..............  ISO 23409 First edition 2011-02-15    Extent of
                                                      Male Condoms--Requirements and test   Recognition.
                                                      methods for condoms made from
                                                      synthetic materials.
9-80...............................           9-121  IEC 60601-2-16 Edition 5.0 2018-04    Withdrawn and
                                                      Medical electrical equipment--Part    replaced with newer
                                                      2-16: Particular requirements for     version.
                                                      the basic safety and essential
                                                      performance of haemodialysis,
                                                      haemodiafiltration and
                                                      haemofiltration equipment.
9-89...............................  ..............  ANSI AAMI ISO 8638:2010 (R2015)       Reaffirmation.
                                                      Cardiovascular implants and
                                                      extracorporeal systems--
                                                      Extracorporeal blood circuit for
                                                      hemodialyzers, hemodiafilters and
                                                      hemofilters.
9-93...............................           9-122  ISO 25841 Third edition 2017-08       Withdrawn and
                                                      Female condoms--Requirements and      replaced with newer
                                                      test methods.                         version.
9-111..............................  ..............  ISO 4074 Third edition 2015-10-15     Extent of
                                                      Natural latex rubber condoms--        Recognition.
                                                      Requirements and test methods.
9-112..............................  ..............  ASTM D3492-16 Standard Specification  Extent of
                                                      for Rubber Contraceptives (Male       Recognition.
                                                      Condoms).
----------------------------------------------------------------------------------------------------------------
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-74..............................  ..............  ISO 10940 Second edition 2009-08-01   Extent of
                                                      Ophthalmic instruments--Fundus        recognition.
                                                      cameras.

[[Page 9359]]

 
10-85..............................  ..............  ISO 11980 Third edition 2012-11-15    Title change. Extent
                                                      Corrected version 2012-12-01          of recognition.
                                                      Ophthalmic optics--Contact lenses
                                                      and contact lens care products--
                                                      Guidance for clinical
                                                      investigations.
10-86..............................  ..............  ISO 14729 First edition 2001-04-15    Extent of
                                                      Ophthalmic optics--Contact lens       recognition.
                                                      care products--Microbiological
                                                      requirements and test methods for
                                                      products and regimens for hygienic
                                                      management of contact lenses
                                                      [Including: Amendment 1 (2010)].
10-89..............................  ..............  ANSI Z80.7-2013 (R2018) American      Reaffirmation. Extent
                                                      National Standard for Ophthalmic      of recognition.
                                                      Optics--Intraocular Lenses.
10-93..............................  ..............  ANSI Z80.27-2014 American National    Extent of
                                                      Standard for Ophthalmics--            recognition.
                                                      Implantable Glaucoma Devices.
10-108.............................  ..............  ISO 18369-2 Third Edition 2017-08     Extent of
                                                      Ophthalmic optics--Contact lenses--   recognition.
                                                      Part 2: Tolerances.
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-184.............................  ..............  ISO 8827 First edition 1988-10-15     Extent of
                                                      Implants for surgery--Staples with    Recognition.
                                                      parallel legs for orthopaedic use--
                                                      General requirements.
11-234.............................          11-342  ASTM F732-17 Standard Test Method     Withdrawn and
                                                      for Wear Testing of Polymeric         replaced with newer
                                                      Materials Used in Total Joint         version.
                                                      Prostheses.
11-243.............................          11-343  ASTM F2346-18 Standard Test Methods   Withdrawn and
                                                      for Static and Dynamic                replaced with newer
                                                      Characterization of Spinal            version.
                                                      Artificial Discs.
11-272.............................  ..............  ASTM F1714-96 (Reapproved 2018)       Reaffirmation.
                                                      Standard Guide for Gravimetric Wear
                                                      Assessment of Prosthetic Hip
                                                      Designs in Simulator Devices.
11-295.............................          11-344  ASTM F2580-18 Standard Practice for   Withdrawn and
                                                      Evaluation of Modular Connection of   replaced with newer
                                                      Proximally Fixed Femoral Hip          version.
                                                      Prosthesis.
11-302.............................          11-345  ASTM F1717-18 Standard Test Methods   Withdrawn and
                                                      for Spinal Implant Constructs in a    replaced with newer
                                                      Vertebrectomy Model.                  version.
11-323.............................          11-346  ASTM F2706-18 Standard Test Methods   Withdrawn and
                                                      for Occipital-Cervical and            replaced with newer
                                                      Occipital-Cervical-Thoracic Spinal    version.
                                                      Implant Constructs in a
                                                      Vertebrectomy Model.
11-331.............................          11-347  ASTM F2077-18 Test Methods for        Withdrawn and
                                                      Intervertebral Body Fusion Devices.   replaced with newer
                                                                                            version.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-29..............................          16-204  ISO 7176-6 Third edition 2018-06      Withdrawn and
                                                      Wheelchairs--Part 6: Determination    replaced with newer
                                                      of maximum speed of electrically      version.
                                                      powered wheelchairs.
16-202.............................          16-205  RESNA WC-4:2017 Standard for          Withdrawn and
                                                      Wheelchairs Volume 4: Wheelchairs     replaced with new
                                                      and Transportation.                   recognition number.
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-102.............................  ..............  ANSI/IES RP-27.2-00/R17 Recommended   Reaffirmation.
                                                      Practice for Photobiological Safety
                                                      for Lamps and Lamp Systems--
                                                      Measurement Techniques.
12-179.............................          12-321  ANSI/IES RP-27.3-17 Recommended       Withdrawn and
                                                      Practice for Photobiological Safety   replaced with newer
                                                      for Lamps--Risk Group                 version.
                                                      Classification and Labeling.
12-231.............................          12-322  NEMA MS 5-2018 Determination of       Withdrawn and
                                                      Slice Thickness in Diagnostic         replaced with newer
                                                      Magnetic Resonance Imaging.           version.
12-247.............................          12-323  ISO 11990 Third edition 2018-08       Withdrawn and
                                                      Lasers and laser-related equipment--  replaced with newer
                                                      Determination of laser resistance     version. Title
                                                      of tracheal tube shaft and tracheal   change.
                                                      tube cuffs.
12-305.............................          12-324  ISO 13694 Third edition 2018-11       Withdrawn and
                                                      Optics and Photonics--Lasers and      replaced with newer
                                                      laser-related equipment--Test         version.
                                                      methods for laser beam power
                                                      (energy) density distribution.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-32..............................  ..............  ANSI AAMI IEC 62304:2006 Medical      Transition period.
                                                      device software--Software life
                                                      cycle processes.
13-79..............................  ..............  IEC 62304 Edition 1.1 2015-06         Title change and
                                                      CONSOLIDATED VERSION Medical device   transition period.
                                                      software--Software life cycle
                                                      processes.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-314.............................  ..............  ANSI/AAMI ST67:2011/(R) 2017          Reaffirmation.
                                                      Sterilization of health care
                                                      products--Requirements and guidance
                                                      for selecting a sterility assurance
                                                      level (SAL) for products labeled
                                                      `sterile'.
14-311.............................          14-518  ANSI/AAMI ST55:2016 Table-top steam   Withdrawn and
                                                      sterilizers.                          replaced with newer
                                                                                            version.
14-396.............................  ..............  ANSI/AAMI ST77:2013/(R) 2018          Reaffirmation.
                                                      Containment devices for reusable
                                                      medical device sterilization.

[[Page 9360]]

 
14-410.............................          14-519  ASTM F17-18 Standard Terminology      Withdrawn and
                                                      Relating to Primary Barrier           replaced with newer
                                                      Packaging.                            version.
14-503.............................          14-520  USP 41-NF36:2018 <61>                 Withdrawn and
                                                      Microbiological Examination of        replaced with newer
                                                      Nonsterile Products: Microbial        version.
                                                      Enumeration Tests.
14-504.............................          14-521  USP 41-NF36:2018 <71> Sterility       Withdrawn and
                                                      Tests.                                replaced with newer
                                                                                            version.
14-505.............................          14-522  USP 41-NF36:2018 <85> Bacterial       Withdrawn and
                                                      Endotoxins Test.                      replaced with newer
                                                                                            version.
14-506.............................          14-523  USP 41-NF36:2018 <161> Medical        Withdrawn and
                                                      Devices--Bacterial Endotoxin and      replaced with newer
                                                      Pyrogen Tests.                        version.
14-507.............................          14-524  USP 41-NF36:2018 <62>                 Withdrawn and
                                                      Microbiological Examination of        replaced with newer
                                                      Nonsterile Products: Tests for        version.
                                                      Specified Microorganisms.
14-508.............................          14-525  USP 41-NF36:2018 <55> Biological      Withdrawn and
                                                      Indicators--Resistance Performance    replaced with newer
                                                      Tests.                                version.
14-509.............................          14-526  USP 41-NF36:2018 <1229.5> Biological  Withdrawn and
                                                      Indicators for Sterilization.         replaced with newer
                                                                                            version.
----------------------------------------------------------------------------------------------------------------
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-47..............................  ..............  ISO 22442-3 First edition 2007-12-15  Extent of
                                                      Medical devices utilizing animal      Recognition.
                                                      tissues and their derivatives--Part
                                                      3: Validation of the elimination
                                                      and/or inactivation of viruses and
                                                      transmissible spongiform
                                                      encephalopathy (TSE) agents.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
\2\ Standards that are ``Withdrawn'' or ``Withdrawn and replaced with newer version'' will have a transition
  period with an expiration date as noted in the recognition database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

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: 051.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                          Reference No.
        Recognition No.          Title of standard \1\      and date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-157.........................  Cardiovascular          ANSI/AAMI/ISO
                                 implants--Endovascula   25539-1: 2017.
                                 r devices--Part 1:
                                 Endovascular
                                 prostheses.
3-158.........................  Standard Guide for      ASTM F3320-18.
                                 Coating
                                 Characterization of
                                 Drug Coated Balloons.
3-159.........................  Cardiovascular          ISO 5910 First
                                 implants and            edition 2018-
                                 extracorporeal          06.
                                 systems--Cardiac
                                 valve repair devices.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-253.........................  Polymer-based           ANSI/ADA
                                 Restorative Materials.  Standard No. 27-
                                                         2016.
4-254.........................  Athletic Mouth          ANSI/ADA
                                 Protectors and          Standard No. 99-
                                 Materials.              2001
                                                         (Reaffirmed
                                                         2013).
4-255.........................  Dental CAD/CAM          ANSI/ADA
                                 Machinable Zirconia     Standard No.
                                 Blanks.                 131-2015.
4-256.........................  Scanning Accuracy of    ANSI/ADA
                                 Dental Chairside and    Standard No.
                                 Laboratory CAD/CAM      132-2015.
                                 Systems.
4-257.........................  Dentistry--Fluoride     ISO 17730 First
                                 varnishes.              edition 2014-11-
                                                         01.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-122.........................  Assessing Credibility   ASME V&V 40-
                                 of Computational        2018.
                                 Modeling Through
                                 Verification and
                                 Validation:
                                 Application to
                                 Medical Devices.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------

[[Page 9361]]

 
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-486.........................  Standard Guide for in   ASTM F3268-18.
                                 vitro Degradation
                                 Testing of Absorbable
                                 Metals.
8-487.........................  Additive                ISO/ASTM52910-
                                 manufacturing--Design   18.
                                 -Requirements,
                                 guidelines and
                                 recommendations.
8-488.........................  Standard for Additive   ASTM F3301-18a.
                                 Manufacturing--Post
                                 Processing Methods--
                                 Standard
                                 Specification for
                                 Thermal Post-
                                 Processing Metal
                                 Parts Made Via Powder
                                 Bed Fusion.
8-489.........................  Standard for Additive   ASTM F3302-18.
                                 Manufacturing--Finish
                                 ed Part Properties--
                                 Standard
                                 Specification for
                                 Titanium Alloys via
                                 Powder Bed Fusion.
8-490.........................  Standard for Additive   ASTM F3303-18.
                                 Manufacturing--Proces
                                 s Characteristics and
                                 Performance: Practice
                                 for Metal Powder Bed
                                 Fusion Process to
                                 Meet Critical
                                 Applications.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
18-11.........................  Nanotechnologies--Nano  ISO/TR 13121
                                 material risk           First edition
                                 evaluation.             2011-05-15.
18-12.........................  Nanotechnology--Nanopa  ISO/TS 17200
                                 rticles in powder       First edition
                                 form--Characteristics   2013-06-01.
                                 and measurements.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
10-114........................  American National       ANSI Z80.28-
                                 Standard for            2017.
                                 Ophthalmics--Methods
                                 of Reporting Optical
                                 Aberrations of Eyes.
10-115........................  American National       ANSI Z80.29-
                                 Standard for            2015.
                                 Ophthalmics--Accommod
                                 ative Intraocular
                                 Lenses.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-348........................  Implants for surgery--  ISO 19227 First
                                 Cleanliness of          edition 2018-
                                 orthopedic implants--   03.
                                 General requirements.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-206........................  Walking aids            ISO 11199-2
                                 manipulated by both     Second edition
                                 arms--Requirements      2005-04-15.
                                 and test methods--
                                 Part 2: Rollators.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-105........................  Classification of       ANSI/AAMI
                                 defects in health       SW91:2018.
                                 software.
13-106........................  Health informatics--    IEEE Std 11073-
                                 Point-of-care medical   10207-2017.
                                 device communication
                                 Part 10207: Domain
                                 Information and
                                 Service Model for
                                 Service-Oriented
                                 Point-of-Care Medical
                                 Device Communication.
13-107........................  Health informatics--    ISO/IEEE 11073-
                                 Point-of-care medical   20702 First
                                 device communication--  edition 2018-
                                 Part 20702: Medical     09.
                                 devices communication
                                 profile for web
                                 services.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
                                No new entries at this
                                 time..
------------------------------------------------------------------------

[[Page 9362]]

 
                          S. Tissue Engineering
------------------------------------------------------------------------
15-56.........................  Standard Test Method    ASTM F3224-17.
                                 for Evaluating Growth
                                 of Engineered
                                 Cartilage Tissue
                                 using Magnetic
                                 Resonance Imaging.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

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. 
Beginning with list 52, FDA will no longer announce in the Federal 
Register updates to current recognized standards for reapproved or 
reaffirmed standards because reapproved or reaffirmed standards have 
not changed from the recognized standard. International and national 
standards developing organizations use the designations of reapproved 
or reaffirmed to indicate a standard has been reviewed but no changes 
were made to the standard at that time.

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 recommendation, to 
CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations 
should contain, at a minimum, the following information available at 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

    Dated: March 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04710 Filed 3-13-19; 8:45 am]
 BILLING CODE 4164-01-P