Document ID: FDA-2004-N-0451-0031
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List Number: 038
Posted Date: 2015-01-27T05:00Z

[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4274-4280]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01420]

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

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: 038

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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: 038'' (Recognition List Number: 038), 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 concerning this 
document at any time. See section VII of this document for the 
effective date of the recognition of standards announced in this 
document.

ADDRESSES: An electronic copy of Recognition List Number: 038 is 
available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of 
this document for electronic access to the searchable database for the 
current list of FDA recognized consensus standards, including 
Recognition List Number: 038 modifications and other standards related 
information.
    Submit written requests for a single copy of the document entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 038'' to the Division of Industry and Consumer Education, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-847-
8149.
    Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring,

[[Page 4275]]

MD 20993, 301-796-6287, standards@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the 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 a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, can be accessed at http://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. Both versions are 
publicly accessible at the Agency's Internet site. See section VI for 
electronic access information. Interested persons should review the 
supplementary information sheet for the standard to understand fully 
the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 038

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in premarket submissions and other requirements for devices. FDA 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. FDA will use 
the term ``Recognition List Number: 038'' to identify these 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 No.        Title of standard \1\                 Change
----------------------------------------------------------------------------------------------------------------
                                                  A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-57............................  ................  ASTM F1101-90 (Reapproved 2003)   Withdrawn.
                                                     Standard Specification for
                                                     Ventilators Intended for Use
                                                     During Anesthesia.
1-69............................  ................  ASTM F1464-93 (Reapproved 2005)   Withdrawn.
                                                     Standard Specification for
                                                     Oxygen Concentrators for
                                                     Domiciliary Use.
1-70............................  ................  ASTM F1246-91 (Reapproved 2005)   Withdrawn.
                                                     Standard Specification for
                                                     Electrically Powered Home Care
                                                     Ventilators--Part 1: Positive-
                                                     Pressure Ventilators and
                                                     Ventilator Circuits.
1-94............................  ................  ISO 8359 Second edition 1996-12-  Withdrawn. See 1-102.
                                                     15, Oxygen concentrators for
                                                     medical use--safety
                                                     requirements [including
                                                     amendment 1 (2012)].
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-143...........................             2-213  ASTM F1904-14 Standard Practice   Withdrawn and replaced
                                                     for the Biological Responses to   with newer version.
                                                     Particles in vivo.
2-144...........................             2-214  ASTM F619-14 Standard Practice    Withdrawn and replaced
                                                     for Extraction of Medical         with newer version.
                                                     Plastics.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-88............................  ................  ASTM F2514-08 (Reapproved 2014)   Reaffirmation.
                                                     Standard Guide for Finite
                                                     Element Analysis (FEA) of
                                                     Metallic Vascular Stents
                                                     Subjected to Uniform Radial
                                                     Loading.
3-123...........................  ................  IEC 80601-2-30 Edition 1.1 2013-  Extent of recognition and
                                                     07, Medical electrical            Process impacted.
                                                     equipment--Part 2-30:
                                                     Particular requirements for the
                                                     basic safety and essential
                                                     performance of automated non-
                                                     invasive sphygmomanometers.
----------------------------------------------------------------------------------------------------------------
                                                  D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-117...........................  ................  ANSI/ADA Specification No. 12:    Withdrawn.
                                                     2002 (Reaffirmed 2008) Denture
                                                     base polymers.
4-134...........................             4-213  ISO 7494-1 Second edition 2011-   Withdrawn and replaced
                                                     08-15 Dentistry--Dental units--   with newer version.
                                                     Part 1: General requirements
                                                     and test methods.
4-135...........................             4-214  ISO 10139-1 Second edition 2005-  Withdrawn and replaced
                                                     02-15, Dentistry--Soft lining     with newer version
                                                     materials for removable           including technical
                                                     dentures--Part 1: Materials for   corrigendum.
                                                     short-term use [Including:
                                                     Technical Corrigendum 1 (2006)].
4-136...........................  ................  ASTM F2504-05 (Reapproved 2014)   Reaffirmation.
                                                     Standard Practice for
                                                     Describing System Output of
                                                     Implantable Middle Ear Hearing
                                                     Devices.

[[Page 4276]]

 
4-143...........................             4-215  ANSI/ADA Standard No. 96: 2012    Withdrawn and replaced
                                                     Dental Water-based Cements.       with newer version.
4-159...........................             4-216  ANSI/IEEE ANSI C63.19-2011        Withdrawn and replaced
                                                     American National Standard        with newer version.
                                                     Methods of Measurement of
                                                     Compatibility between Wireless
                                                     Communications Devices and
                                                     Hearing Aids.
4-170...........................             4-217  ANSI/ASA S3.36-2012 American      Withdrawn and replaced
                                                     National Standard Specification   with newer version.
                                                     for a Manikin for Simulated in-
                                                     situ Airborne Acoustic
                                                     Measurements.
4-183...........................  ................  ANSI/ASA S3.2-2009 (Reaffirmed    Reaffirmation.
                                                     2014) American National
                                                     Standard Method for Measuring
                                                     the Intelligibility of Speech
                                                     over Communication Systems.
4-185...........................  ................  ANSI/ASA S3.45-2009 (Reaffirmed   Reaffirmation.
                                                     2014) American National
                                                     Standard Procedures for Testing
                                                     Basic Vestibular Function.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management (QS/RM))
----------------------------------------------------------------------------------------------------------------
5-48............................  ................  ANSI/ASQ Z1.9-2003 (R2013)        Reaffirmation.
                                                     Sampling Procedures and Tables
                                                     for Inspection by Variables for
                                                     Percent Nonconforming.
5-57............................  ................  ANSI/AAMI HE75:2009/(R)2013       Reaffirmation.
                                                     Human factors engineering--
                                                     Design of medical devices.
5-62............................  ................  ANSI/ASQ Z1.4-2003 (R2013)        Reaffirmation.
                                                     Sampling Procedures and Tables
                                                     for Inspection by Attributes.
----------------------------------------------------------------------------------------------------------------
                              F. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-199...........................             6-335  ASTM F2101-14 Standard Test       Withdrawn and replaced
                                                     Method for Evaluating the         with newer version.
                                                     Bacterial Filtration Efficiency
                                                     (BFE) of Medical Face Mask
                                                     Materials, Using a Biological
                                                     Aerosol of Staphylococcus
                                                     aureus.
6-217...........................  ................  ASTM F1670/F1670M-08 (Reapproved  Reaffirmation.
                                                     2014)\[epsiv]1\ Standard Test
                                                     Method for Resistance of
                                                     Materials Used in Protective
                                                     Clothing to Penetration by
                                                     Synthetic Blood.
6-228...........................             6-336  IEC 60601-2-2 Edition 5.0 2009-   Withdrawn and replaced
                                                     02 Medical Electrical             with newer version
                                                     Equipment--Part 2-2: Particular   including technical
                                                     Requirements for the Basic        corrigendum.
                                                     Safety and Essential
                                                     Performance of High Frequency
                                                     Surgical Equipment and High
                                                     Frequency Surgical Accessories
                                                     [Including: Technical
                                                     Corrigendum 1 (2014)].
6-231...........................             6-337  ANSI/AAMI/IEC 60601-2-20:2009     Withdrawn and replaced
                                                     Medical Electrical Equipment--    with newer version
                                                     Part 2-20: Particular             including erratum.
                                                     Requirements for the Basic
                                                     Safety and Essential
                                                     Performance of Infant Transport
                                                     Incubators [Including: Erratum
                                                     (2012)].
----------------------------------------------------------------------------------------------------------------
                                          G. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-84............................  ................  CEN 13640, Stability Testing of   Withdrawn.
                                                     In Vitro Diagnostic Reagents.
7-162...........................  ................  CLSI POCT14-A (Formerly H49-A)    Withdrawn duplicate. See 7-
                                                     Point-Of-Care Monitoring of       112.
                                                     Anticoagulation Therapy;
                                                     Approved Guideline.
7-184...........................             7-250  CLSI M40-A2 Quality Control of    Withdrawn and replaced
                                                     Microbiological Transport         with newer version.
                                                     Systems; Approved Standard--
                                                     Second Edition.
----------------------------------------------------------------------------------------------------------------
                                                  H. Materials
----------------------------------------------------------------------------------------------------------------
8-111...........................             8-380  ASTM F1160-14 Standard Test       Withdrawn and replaced
                                                     Method for Shear and Bending      with newer version.
                                                     Fatigue Testing of Calcium
                                                     Phosphate and Metallic Medical
                                                     and Composite Calcium Phosphate/
                                                     Metallic Coatings.
8-124...........................             8-381  ASTM F2052-14 Standard Test       Withdrawn and replaced
                                                     Method for Measurement of         with newer version.
                                                     Magnetically Induced
                                                     Displacement Force on Medical
                                                     Devices in the Magnetic
                                                     Resonance Environment.
8-171...........................  ................  ASTM F1609-08 (Reapproved 2014)   Reaffirmation.
                                                     Standard Specification for
                                                     Calcium Phosphate Coatings for
                                                     Implantable Materials.
8-198...........................             8-382  ASTM F2102-13 Standard Guide for  Withdrawn and replaced
                                                     Evaluating the Extent of          with newer version.
                                                     Oxidation in Polyethylene
                                                     Fabricated Forms Intended for
                                                     Surgical Implants.
8-207...........................             8-383  ASTM F1926/F1926M-14 Standard     Withdrawn and replaced
                                                     Test Method for Dissolution       with newer version.
                                                     Testing of Calcium Phosphate
                                                     Granules, Fabricated Forms, and
                                                     Coatings.
8-340...........................             8-384  ASTM F2026-14 Standard            Withdrawn and replaced
                                                     Specification for                 with newer version.
                                                     Polyetheretherketone (PEEK)
                                                     Polymers for Surgical Implant
                                                     Applications.
8-357...........................             8-385  ASTM F648-14 Standard             Withdrawn and replaced
                                                     Specification for Ultra-High-     with newer version.
                                                     Molecular-Weight Polyethylene
                                                     Powder and Fabricated Form for
                                                     Surgical Implants.
----------------------------------------------------------------------------------------------------------------

[[Page 4277]]

 
                                       I. OB-GYN/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-6.............................              9-95  IEC 60601-2-36 Edition 2.0 2014-  Withdrawn and replaced
                                                     04 Medical electrical             with newer version.
                                                     equipment--Part 2-36:
                                                     Particular requirements for the
                                                     basic safety and essential
                                                     performance of equipment for
                                                     extracorporeally induced
                                                     lithotripsy.
9-45............................  ................  ASTM F2528-06 (Reapproved 2014)   Reaffirmation.
                                                     Standard Test Methods for
                                                     Enteral Feeding Devices with a
                                                     Retention Balloon.
9-62............................              9-96  IEC 60601-2-2 Edition 5.0 2009-   Withdrawn and replaced
                                                     02 Medical Electrical             with newer version
                                                     Equipment--Part 2-2: Particular   including technical
                                                     Requirements for the Basic        corrigendum.
                                                     Safety and Essential
                                                     Performance of High Frequency
                                                     Surgical Equipment and High
                                                     Frequency Surgical Accessories
                                                     [Including: Technical
                                                     Corrigendum 1 (2014)].
9-74............................              9-97  ISO 13958 Third edition 2014-04-  Withdrawn and replaced
                                                     01 Concentrates for               with newer version.
                                                     haemodialysis and related
                                                     therapies.
9-76............................              9-98  ISO 13959 Third edition 2014-04-  Withdrawn and replaced
                                                     01 Water for haemodialysis and    with newer version.
                                                     related therapies.
9-77............................              9-99  ISO 23500 Second edition 2014-04- Withdrawn and replaced
                                                     01 Guidance for the preparation   with newer version.
                                                     and quality management of
                                                     fluids for haemodialysis and
                                                     related therapies.
9-78............................             9-100  ISO 11663 Second edition 2014-04- Withdrawn and replaced
                                                     01 Quality of dialysis fluid      with a newer version.
                                                     for haemodialysis and related
                                                     therapies.
9-79............................             9-101  ISO 26722 Second edition 2014-04- Withdrawn and replaced
                                                     01 Water treatment equipment      with a newer version.
                                                     for haemodialysis applications
                                                     and related therapies.
9-82............................             9-102  ISO 4074 Second edition 2014-08-  Withdrawn and replaced
                                                     15 Natural rubber latex male      with newer version.
                                                     condoms--Requirements and test
                                                     methods.
----------------------------------------------------------------------------------------------------------------
                                                  J. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-49...........................             10-90  ISO 11979-9 First edition 2006-   Withdrawn and replaced
                                                     09-01 Ophthalmic implants--       with newer version
                                                     Intraocular lenses--Part 9:       including amendment.
                                                     Multifocal intraocular lenses
                                                     [Including: Amendment 1(2014)].
10-50...........................             10-91  ISO 11979-10 First edition 2006-  Withdrawn and replaced
                                                     08-15 Ophthalmic implants--       with newer version
                                                     Intraocular lenses--Part 10:      including amendment.
                                                     Phakic intraocular lenses
                                                     [Including: Amendment 1 (2014)].
10-80...........................  ................  ISO 18369-2 Second edition 2012-  Extent of recognition and
                                                     12-01 Ophthalmic optics--         relevant guidance.
                                                     Contact lenses--Part 2:
                                                     Tolerances.
----------------------------------------------------------------------------------------------------------------
                                                  K. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-196..........................            11-281  ASTM F1672-14 Standard            Withdrawn and replaced
                                                     Specification for Resurfacing     newer version.
                                                     Patellar Prosthesis.
11-213..........................            11-282  ASTM F1223-14 Standard Test       Withdrawn and replaced
                                                     Method for Determination of       with newer version.
                                                     Total Knee Replacement
                                                     Constraint.
11-260..........................            11-283  ASTM F2943-14 Standard Guide for  Withdrawn and replaced
                                                     Presentation of End User          with newer version.
                                                     Labeling Information for
                                                     Musculoskeletal Implants.
11-263..........................            11-284  ASTM F2028-14 Standard Test       Withdrawn and replaced
                                                     Methods for Dynamic Evaluation    with newer version.
                                                     of Glenoid Loosening or
                                                     Disassociation.
----------------------------------------------------------------------------------------------------------------
                                              L. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-189..........................            16-193  ASME A18.1-2014 Safety Standard   Withdrawn and replaced
                                                     for Platform Lifts and Stairway   with newer version.
                                                     Chairlifts.
----------------------------------------------------------------------------------------------------------------
                                                  M. Radiology
----------------------------------------------------------------------------------------------------------------
12-181..........................            12-284  NEMA NU 1-2012 Performance        Withdrawn and replaced
                                                     Measurements of Gamma Cameras.    with newer version.
12-206..........................            12-285  IEC 60601-2-1 Edition 3.1 2014-   Withdrawn and replaced
                                                     07 Medical electrical             with newer version.
                                                     equipment--Part 2-1: Particular
                                                     requirements for the basic
                                                     safety and essential
                                                     performance of electron
                                                     accelerators in the range 1 MeV
                                                     to 50 MeV.
12-230..........................  ................  NEMA XR 24-2008 (R2014) Primary   Reaffirmation.
                                                     User Controls for
                                                     Interventional Angiography X-
                                                     Ray Equipment.
----------------------------------------------------------------------------------------------------------------
                                                  N. Sterility
----------------------------------------------------------------------------------------------------------------
14-139..........................  ................  ISO 14644-1 First edition 1999-   Relevant guidance.
                                                     05-01 Cleanrooms and associated
                                                     controlled environments--Part
                                                     1: Classification of air
                                                     cleanliness.

[[Page 4278]]

 
14-140..........................  ................  ISO 14644-2 First edition 2000-   Relevant guidance.
                                                     09-15 Cleanrooms and associated
                                                     controlled environments--Part
                                                     2: Specifications for testing
                                                     and monitoring to prove
                                                     continued compliance with ISO
                                                     14644-1.
14-141..........................  ................  ISO 14644-4 First edition 2001-   Relevant guidance.
                                                     04-01 Cleanrooms and associated
                                                     controlled environments--Part
                                                     4: Design, construction and
                                                     start-up.
14-165..........................  ................  ISO 14644-5 First edition 2004-   Relevant guidance.
                                                     08-15 Cleanrooms and associated
                                                     controlled environments--Part
                                                     5: Operations.
14-166..........................  ................  ISO 14644-7 First edition 2004-   Relevant guidance.
                                                     10-01 Cleanrooms and associated
                                                     controlled environments--Part
                                                     7: Separative devices (clean
                                                     air hoods, gloveboxes,
                                                     isolators and mini-
                                                     environments).
14-193..........................  ................  ANSI/AAMI/ISO 11607-1:2006/       Relevant guidance.
                                                     (R)2010, Packaging for
                                                     terminally sterilized medical
                                                     devices--Part 1: Requirements
                                                     for materials, sterile barrier
                                                     systems, and packaging systems.
14-194..........................  ................  ANSI/AAMI/ISO 11607-2:2006/       Relevant guidance.
                                                     (R)2010, Packaging for
                                                     terminally sterilized medical
                                                     devices--Part 2: Validation
                                                     requirements for forming,
                                                     sealing and assembly processes.
14-238..........................  ................  AAMI/ANSI/ISO 11140-5:2007/       Relevant guidance.
                                                     (R)2012, Sterilization of
                                                     health care products--Chemical
                                                     indicators--Part 5: Class 2
                                                     indicators for Bowie and Dick
                                                     air removal test sheets and
                                                     packs.
14-242..........................  ................  ISO 14644-3 First edition 2005-   Relevant guidance.
                                                     12-15 Cleanrooms and associated
                                                     controlled environments--Part
                                                     3: Test methods.
14-243..........................  ................  ISO 14644-6 First edition         Relevant guidance.
                                                     Cleanrooms and associated
                                                     controlled environments--Part
                                                     6: Vocabulary.
14-274..........................  ................  ANSI/AAMI/ISO 15882:2008/         Reaffirmation.
                                                     (R)2013, Sterilization of
                                                     health care products--Chemical
                                                     indicators--Guidance for
                                                     selection, use and
                                                     interpretation of results.
14-299..........................            14-453  ASTM F2097-14 Standard Guide for  Withdrawn and replaced
                                                     Design and Evaluation of          with newer version.
                                                     Primary Flexible Packaging for
                                                     Medical Products.
14-355..........................            14-454  ISO 11607-1 First edition 2006-   Withdrawn and replaced
                                                     04-15 Packaging for terminally    with newer version
                                                     sterilized medical devices--      including amendment.
                                                     Part 1: Requirements for
                                                     materials, sterile barrier
                                                     systems and packaging systems
                                                     [Including: Amendment 1 (2014)].
14-356..........................            14-455  ISO 11607-2 First edition 2006-   Withdrawn and replaced
                                                     04-15 Packaging for terminally    with newer version
                                                     sterilized medical devices--      including amendment.
                                                     Part 2: Validation requirements
                                                     for forming, sealing and
                                                     assembly processes [Including:
                                                     Amendment 1 (2014)].
14-379..........................  ................  ISO 14644-8 Second edition 2013-  Relevant guidance.
                                                     02-15 Cleanrooms and associated
                                                     controlled environments--Part
                                                     8: Classification of air
                                                     cleanliness by chemical
                                                     concentration (ACC).
14-389..........................  ................  ISO 14644-9 First edition 2012-   Relevant guidance.
                                                     08-15 Cleanrooms and associated
                                                     controlled environments--Part
                                                     9: Classification of surface
                                                     cleanliness by particle
                                                     concentration.
14-390..........................  ................  ISO 14644-10 First edition 2013-  Relevant guidance.
                                                     03-01 Cleanrooms and associated
                                                     controlled environments--Part
                                                     10: Classification of surface
                                                     cleanliness by chemical
                                                     concentration.
----------------------------------------------------------------------------------------------------------------
\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: 038.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
    Recognition No.       Title of standard \1\   Reference No. and date
------------------------------------------------------------------------
                              A. Anesthesia
------------------------------------------------------------------------
1-102..................  Medical electrical       ISO 80601-2-69 First
                          equipment--Part 2-69:    edition 2014-07-15.
                          Particular
                          requirements for basic
                          safety and essential
                          performance of oxygen
                          concentrator equipment.
------------------------------------------------------------------------
                            B. Cardiovascular
------------------------------------------------------------------------
3-133..................  International Standard-  ISO 5840-3 First
                          Cardiovascular           edition 2013-03-01.
                          implants--Cardiac
                          valve prostheses--Part
                          3: Heart valve
                          substitutes implanted
                          by transcatheter
                          techniques.
------------------------------------------------------------------------

[[Page 4279]]

 
                     C. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
4-218..................  International Standard-  ISO 27020 First
                          Dentistry--Brackets      edition 2010-12-15.
                          and tubes for use in
                          orthodontics.
4-219..................  International Standard-  ISO 29022 First
                          Dentistry-Adhesive-Not   edition 2013-06-01.
                          ched Edge Sheer Bond
                          Strength Test.
------------------------------------------------------------------------
               D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-338..................  Standard Specification   ASTM D7866-14a.
                          for Radiation
                          Attenuating Protective
                          Gloves.
6-339..................  Standard Consumer        ASTM F1169-13.
                          Safety Specification
                          for Full-Size Baby
                          Cribs.
6-340..................  Standard Consumer        ASTM F2710-13.
                          Safety Performance
                          Specification for
                          Commercial Cribs.
------------------------------------------------------------------------
                            E. Nanotechnology
------------------------------------------------------------------------
18-3...................  Technical                ISO/TS 14101 First
                          Specification--Surface   edition 2012-11-01.
                          characterization of
                          gold nanoparticles for
                          nanomaterial specific
                          toxicity screening: FT-
                          IR method.
------------------------------------------------------------------------
                              F. Neurology
------------------------------------------------------------------------
17-13..................  IEEE Recommended         IEEE Std 2010-2012.
                          Practice for
                          Neurofeedback Systems.
------------------------------------------------------------------------
                             G. Ophthalmics
------------------------------------------------------------------------
10-92..................  American National        ANSI Z80.20-2010
                          Standard for             (Revision of ANSI
                          Ophthalmics-Contact      Z80.20-2004) 12/06/
                          Lenses--Standard         2010.
                          Terminology,
                          Tolerances,
                          Measurements and
                          Physicochemical
                          Properties.
10-93..................  American National        ANSI Z80.27-2014
                          Standard for             (revision of ANSI
                          Ophthalmics-             Z80.27-2001 (R2011))
                          Implantable Glaucoma     01/27/2014.
                          Devices.
------------------------------------------------------------------------
                              H. Orthopedic
------------------------------------------------------------------------
11-285.................  Guide to Optimize Scan   ASTM F2978-13.
                          Sequences for Clinical
                          Diagnostic Evaluation
                          of Metal-on-Metal Hip
                          Arthroplasty Devices
                          using Magnetic
                          Resonance Imaging.
11-286.................  Guide For the            ASTM F2979-14.
                          Characterization of
                          Wear from the
                          Articulating Surfaces
                          in Retrieved Metal-on-
                          Metal and other Hard-
                          on-Hard Prostheses.
------------------------------------------------------------------------
                              I. Radiology
------------------------------------------------------------------------
12-286.................  X-ray Equipment for      NEMA XR-27-2013 with
                          Interventional           Amendment 1.
                          Procedures--User
                          Quality Control Mode.
12-287.................  Supplemental             NEMA XR 28-2013.
                          Requirements for User
                          Information and System
                          Function Related to
                          Dose in CT.
12-288.................  Characterization of      NEMA MS 9-2008.
                          Phased Array Coils for
                          Diagnostic Magnetic
                          Resonance Images (MRI).
------------------------------------------------------------------------
                         J. Software/Informatics
------------------------------------------------------------------------
13-70..................  Application of risk      IEC TR 80001-2-5 2014.
                          management for IT-
                          networks incorporating
                          medical devices--Part
                          2-5: Application
                          guidance--Guidance on
                          distributed alarm
                          systems.
13-71..................  Logical Observation      LOINC 2.48 2014-06-27.
                          Identifiers Names and
                          Codes (LOINC).
13-72..................  Health informatics--     IEEE Std 11073-10425-
                          Personal health device   2014.
                          communication, Part
                          10425: Device
                          Specialization--Contin
                          uous Glucose Monitor
                          (CGM).
------------------------------------------------------------------------
                              K. Sterility
------------------------------------------------------------------------
14-456.................  Packaging for            ISO/TS 16775 First
                          terminally sterilized    edition 2014-05-15.
                          medical devices--
                          Guidance on the
                          application of ISO
                          11607-1 and ISO 11607-
                          2.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

[[Page 4280]]

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed directly at 
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications 
and revisions described in this notice into the database and, upon 
publication in the Federal Register, this recognition of consensus 
standards will be effective. 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 Recognition List 033, FDA no longer announces minor 
revisions to the list of recognized consensus standards such as 
technical contact person, devices affected, processes affected, Code of 
Federal Regulations citations, and product codes.

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 
standards@cdrh.fda.gov. To be properly considered, such recommendations 
should contain, at a minimum, the following information: (1) Title of 
the standard, (2) any reference number and date, (3) name and address 
of the national or international standards development organization, 
(4) a proposed list of devices for which a declaration of conformity to 
this standard should routinely apply, and (5) a brief identification of 
the testing or performance or other characteristics of the device(s) 
that would be addressed by a declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains a site on the Internet for easy 
access to information including text, graphics, and files that you may 
download to a personal computer with access to the Internet. Updated on 
a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices, 
includes a link to standards-related documents including the guidance 
and the current list of recognized standards. After publication in the 
Federal Register, this notice announcing ``Modification to the List of 
Recognized Standards, Recognition List Number: 038'' will be available 
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition 
and Use of Consensus Standards,'' and the searchable database for ``FDA 
Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

VII. Submission of Comments and Effective Date

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. 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: 038. These 
modifications to the list of recognized standards are effective upon 
publication of this notice in the Federal Register.

    Dated: January 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01420 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P