Skip to Content

Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Printed Page 39591

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: 047” (Recognition List Number: 047), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective August 21, 2017.

ADDRESSES:

You may submit comments 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: 047.” 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: 047.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.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: 047 is available on the Internet at https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm. See Section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 047 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: 047” to 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. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

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

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (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 the Federal Register notice 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 Start Printed Page 39592standards. The guidance was updated in September 2007 and is available at https://www.fda.gov/​downloads/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​ucm077295.pdf.

Modifications to the initial list of recognized standards 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: 047

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: 047” 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

Old recognition No.Replacement recognition No.Title of standard 1Change
A. Anesthesiology
No new entries at this time.
B. Biocompatibility
2-1142-246ASTM F1877—16 Standard Practice for Characterization of ParticlesWithdrawn and replaced with newer version.
2-155ASTM F2147—01 (Reapproved 2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact AllergensReaffirmation.
2-1772-247ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices—Part 6: Tests for local effects after implantationWithdrawn and replaced with newer version.
2-2352-248ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with bloodWithdrawn and replaced with newer version. Extent of recognition.
C. Cardiovascular
3-1213-149ISO 25539-1 Second edition 2017-02 Cardiovascular implants—Endovascular devices—Part 1: Endovascular prosthesesWithdrawn and replaced with newer version.
3-142ISO/TS 17137 First edition 2014-05-15 Cardiovascular implants and extracorporeal systems—Cardiovascular absorbable implantsExtent of recognition.
D. Dental/Ear, Nose, and Throat (ENT)
4-964-230ANSI/ADA Standard No. 30-2013/ISO 3107 Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol CementsWithdrawn and replaced with newer version. Extent of recognition.
4-193ANSI/ADA Standard No. 15-2008 (R2013)/ISO 22112 Artificial Teeth for Dental ProsthesesExtent of recognition.
4-215ANSI/ADA Standard No. 96-2012 Dental Water-based CementsExtent of recognition.
E. General I (Quality Systems/Risk Management) (QS/RM)
5-905-117ISO 15223-1 Third edition 2016-11-01 Medical devices—symbols to be used with medical device labels, labelling, and information to be supplied—part 1: General requirementsWithdrawn and replaced with newer version.
5-915-118ANSI/AAMI/ISO 15223-1: 2016 Medical devices—symbols to be used with medical device labels, labelling, and information to be supplied—part 1: General requirementsWithdrawn and replaced with newer version.
5-107IEC 80369-5: Edition 1.0 2016-03 Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications [Including CORRIGENDUM 1 (2017)]Technical corrigendum added.
Start Printed Page 39593
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time
G. General Hospital/General Plastic Surgery (GH/GPS)
6-70ASTM E825-98 (Reapproved 2016) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human TemperatureReaffirmation.
6-124ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and SheathsReaffirmation
6-125ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient TemperatureReaffirmation.
6-2976-384ISO 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feedWithdrawn and replaced with newer version.
6-3196-385IEC 60601-2-19 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators [Including AMENDMENT 1 (2016)]Withdrawn and replaced with newer version including amendment.
6-3206-386IEC 60601-2-20 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including AMENDMENT 1 (2016)]Withdrawn and replaced with newer version including amendment.
6-3246-387IEC 60601-2-50 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including AMENDMENT 1 (2016)]Withdrawn and replaced with newer version including amendment.
6-3256-388IEC 60601-2-21 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including AMENDMENT 1 (2016)]Withdrawn and replaced with newer version including amendment.
6-3366-389IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessoriesWithdrawn and replaced with newer version.
6-3426-390IEC 80601-2-35 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including AMENDMENT 1 (2016)]Withdrawn and replaced with newer version including amendment.
6-3676-391USP 40-NF35:2017, Sodium Chloride IrrigationWithdrawn and replaced with newer version.
6-3686-392USP 40-NF35:2017, Sodium Chloride InjectionWithdrawn and replaced with newer version.
6-3696-393USP 40-NF35:2017, Nonabsorbable Surgical SutureWithdrawn and replaced with newer version.
6-3706-394USP 40-NF35:2017, <881> Tensile StrengthWithdrawn and replaced with newer version.
6-3716-395USP 40-NF35:2017, <861> Sutures—DiameterWithdrawn and replaced with newer version.
6-3726-396USP 40-NF35:2017, <871> Sutures—Needle AttachmentWithdrawn and replaced with newer version.
6-3736-397USP 40-NF35:2017, Sterile Water for IrrigationWithdrawn and replaced with newer version.
6-3746-398USP 40-NF35:2017, Heparin Lock Flush SolutionWithdrawn and replaced with newer version.
6-3756-399USP 40-NF35:2017, Absorbable Surgical SutureWithdrawn and replaced with newer version.
H. In Vitro Diagnostics (IVD)
7-2067-270I/LA-20 3rd Edition Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen SpecificitiesWithdrawn and replaced with newer version.
Start Printed Page 39594
7-2637-271CLSI M100 27th Edition Performance Standards for Antimicrobial Susceptibility TestingWithdrawn and replaced with newer version.
I. Materials
8-588-447ISO 5832-3 Fourth edition 2016-10-15 Implants for surgery—Metallic materials—Part 3: Wrought titanium 6-aluminium 4-vanadium alloyWithdrawn and replaced with newer version. Extent of recognition.
8-1258-448ASTM F2004-16 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal AnalysisWithdrawn and replaced with newer version.
8-1658-449ASTM F1058-16 Standard Specification for Wrought 40Cobalt-20 Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)Withdrawn and replaced with newer version.
8-1858-450ASTM F451-16 Standard Specification for Acrylic Bone CementWithdrawn and replaced with newer version.
8-187ISO 13779-1:2008 Second edition 2008-10-01 Implants for surgery—Hydroxyapatite—Part 1: Ceramic hydroxyapatiteWithdrawn.
8-195ASTM F2024-10 (Reapproved 2016) Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsReaffirmation.
8-2018-451ASTM F2214-16 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)Withdrawn and replaced with newer version.
8-202ASTM F2183-02 (Reapproved 2008) Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)Withdrawn.
8-2058-452ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical ImplantsWithdrawn and replaced with newer version.
8-2168-453ASTM F1295-16 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)Withdrawn and replaced with newer version.
8-226ASTM F603-12 (Reapproved 2016) Standard Specification for High-Purity Dense Aluminum Oxide for Medical ApplicationReaffirmation.
8-333ASTM F2393-12 (Reapproved 2016) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant ApplicationsReaffirmation.
8-3968-454ASTM F2129-17 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesWithdrawn and replaced with newer version.
8-428ASTM F1581-08 (Reapproved 2016) Standard Specification for Composition of Anorganic Bone for Surgical ImplantsReaffirmation.
8-4108-455ASTM F2902-16 Standard Guide for Assessment of Absorbable Polymeric ImplantsWithdrawn and replaced with newer version.
J. Nanotechnology
No new entries at this time.
K. Neurology
No new entries at this time.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
10-6910-103ANSI Z80.18-2016 American National Standard for Ophthalmics—Contact Lens Care Products—Vocabulary, Performance Specifications, and Test MethodologyWithdrawn and replaced with newer version.
10-9210-104ANSI Z80.20-2016 American National Standard for Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical PropertiesWithdrawn and replaced with newer version.
N. Orthopedic
11-175ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal ImplantsReaffirmation.
Start Printed Page 39595
11-242ASTM F1839-08 (Reapproved 2016) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and InstrumentsReaffirmation.
11-269ASTM F2423-11 (Reapproved 2016) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc ProsthesesReaffirmation.
11-280ASTM F2624-12 (Reapproved 2016) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal ConstructsReaffirmation.
11-309ASTM F116-12 (Reapproved 2016) Standard Specification for Medical Screwdriver BitsReaffirmation.
O. Physical Medicine
No new entries at this time.
P. Radiology
12-23412-306NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special ApplicationsWithdrawn and replaced with newer version.
Q. Software/Informatics
13-6613-88ISO/IEEE 11073-10417 Third edition 2017-04 Health informatics—Personal health device communication—Part 10417: Device specialization—Glucose meterWithdrawn and replaced with newer version.
13-67ISO/IEEE 11073-10418 First edition 2014-03-01 Health informatics—Personal health device communication—Part 10418: Device specialization: International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]Technical Corrigendum added.
R. Sterility
14-28814-501ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual InspectionWithdrawn and replaced with newer version.
14-33814-502ISO 11138-1 Third edition 2017-03 Sterilization of health care products—Biological indicators—Part 1: General requirementsWithdrawn and replaced with newer version.
14-358ANSI/AAMI/ISO 14160:2011/(R)2016 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesReaffirmation. Extent of recognition.
14-361ISO 14160 Second edition 2011-07-01 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesExtent of recognition.
14-48514-503USP 40-NF35:2017, <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version.
14-48614-504USP 40-NF35:2017, <71> Sterility TestsWithdrawn and replaced with newer version.
14-48714-505USP 40-NF35:2017, <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version.
14-48814-506USP 40-NF35:2017, <161> Medical Devices-Bacterial Endotoxin and Pyrogen TestsWithdrawn and replaced with newer version.
14-49314-507USP 40-NF35:2017, <62> Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsWithdrawn and replaced with newer version.
14-49414-508USP 40-NF35:2017, <55> Biological Indicators—Resistance Performance TestsWithdrawn and replaced with newer version.
14-49514-509USP 40-NF35:2017, <1229.5> Biological Indicators for SterilizationWithdrawn and replaced with newer version.
Start Printed Page 39596
S. Tissue Engineering
15-2015-49ASTM F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical ProductsWithdrawn and replaced with newer version.
1 All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 047.

Table 2—New Entries to the List of Recognized Standards

Recognition No.Title of standard 1Reference No. and date
A. Anesthesiology
1-121Anaesthetic and respiratory equipment—Low-pressure hose assemblies for use with medical gasesISO 5359 Fourth edition 2014-10-01.
1-122Anaesthetic and respiratory equipment—Oropharyngeal airwaysISO 5364 Fifth edition 2016-09-01.
1-123Anaesthetic and respiratory equipment—Laryngoscopes for tracheal intubationISO 7376 Second edition 2009-08-15.
1-124Inhalational anaesthesia systems—Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gasesISO 8835-7 First edition 2011-11-01.
1-125Suction catheters for use in the respiratory tractISO 8836 Fourth edition 2014-10-15.
1-126Anaesthetic and respiratory equipment—Supralaryngeal airways and connectorsISO 11712 First edition 2009-05-15.
1-127Tracheobronchial tubes—Sizing and markingISO 16628 First edition 2008-11-15.
1-128Anaesthetic and respiratory equipment—Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gasesISO 18082 First edition 2014-06-15.
B. Biocompatibility
No new entries at this time.
C. Cardiovascular
No new entries at this time.
D. Dental/Ear, Nose, and Throat (ENT)
4-231Dentistry—Testing of adhesion to tooth structureISO/TS 11405 Third edition 2015-02-01.
4-232Dentistry—Base polymers—Part 1: Denture base polymersISO 20795-1 Second edition 2013-03-01.
4-233Dentistry—Base polymers—Part 2: Orthodontic base polymersISO 20795-2 Second edition 2013-03-01.
4-234Dental Base PolymersANSI/ADA Standard No.139-2012.
4-235Orthodontic Brackets and TubesANSI/ADA Standard No.100-2012/ISO 27020.
4-236Manual ToothbrushesANSI/ADA Standard No.119-2015.
4-237Powered ToothbrushesANSI/ADA Standard No.120-2009 (R2014)/ISO 20127.
4-238Dentistry—Powered toothbrushes—General requirements and test methodsISO 20127 First edition 2005-03-15.
4-239Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability ReportingANSI/AAMI CI 86:2017.
E. General I (Quality Systems/Risk Management) (QS/RM)
5-119Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applicationsANSI/AAMI/ISO 80369-5: 2016.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19-22Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systemsAAMI TIR69: 2017.
19-23Primary batteries—Part 4: Safety of lithium batteriesIEC 60086-4 Edition 4.0 2014-09.
19-24Primary batteries—Part 5: Safety of batteries with aqueous electrolyteIEC 60086-5 Edition 4.0 2016-07.
19-25Safety requirements for secondary batteries and battery installations—Part 1: General safety informationIEC 62485-1 Edition 1.0 2015-04.
19-26Safety requirements for secondary batteries and battery installations—Part 2: Stationary batteriesIEC 62485-2 Edition 1.0 2010-06.
19-27Safety requirements for secondary batteries and battery installations—Part 3: Traction batteriesIEC 62485-3 Edition 2.0 2014-07.
19-28Safety requirements for secondary batteries and battery installations—Part 4: Valve-regulated lead-acid batteries for use in portable appliancesIEC 62485-4 Edition 1.0 2015-01.
19-29American National Standard for Evaluation of Wireless CoexistenceIEEE/ANSI C63.27-2017.
Start Printed Page 39597
G. General Hospital/General Plastic Surgery (GH/GPS)
6-400Standard Test Method for Coring Testing of Huber NeedlesASTM F3212-16.
H. In Vitro Diagnostics (IVD)
7-272Mass Spectrometry for Androgen and Estrogen Measurements in SerumCLSI C57 First edition.
7-273Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass SpectrometryCLSI M58.
I. Materials
8-456Implants for surgery—Plasma-sprayed unalloyed titanium coatings on metallic surgical implants—Part 1: General requirementsISO 13179-1 First edition 2014-06-01.
8-457Implants for surgery—Calcium phosphates—Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutesISO 13175-3 First edition 2012-10-01.
8-458Standard Reference Test Method for Making Potentiodynamic Anodic Polarization MeasurementsASTM G5-14.
8-459PyrometrySAE/AMS2750 Rev. E 2012-07.
J. Nanotechnology
18-5Standard Guide for Size Measurement of Nanoparticles Using Atomic Force MicroscopyASTM E2859-11.
18-6Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological MaterialsASTM E2865-12.
18-7Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)ASTM E2834-12.
18-8Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size DistributionsASTM E2578-07 (Reapproved 2012).
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
No new entries at this time.
N. Orthopedic
11-321Standard Specification for Total Elbow ProsthesesASTM F2887-17.
O. Physical Medicine
16-200Wheelchairs—Part 19: Wheeled mobility devices for use as seats in motor vehiclesISO 7176-19 Second edition 2008-07-15.
P. Radiology
No new entries at this time.
Q. Software/Informatics
13-89Health informatics—Personal health device communication—Part 10406: Device specialization—Basic electrocardiograph (ECG) (1- to 3-lead ECG)ISO/IEEE 11073-10406 First edition 2012-12-01.
13-90Health Informatics—Personal Health Device Communication, Part 10417: Device Specialization—Glucose MeterIEEE Std 11073-10417-2015.
13-91Health informatics—Personal health device communication—Part 10419: Device specialization—Insulin pumpISO/IEEE 11073-10419 First edition 2016-06-15.
13-92Health informatics—Personal health device communication—Part 10421: Device specialization—Peak expiratory flow monitor (peak flow)ISO/IEEE 11073-10421 First edition 2012-11-01.
13-93Health informatics—Personal health device communication, Part 10422: Device Specialization—Urine AnalyzerIEEE Std 11073-10422-2016.
13-94Health informatics—Personal health device communication—Part 10424: Device specialization—Sleep Apnoea Breathing Therapy Equipment (SABTE)ISO/IEEE 11073-10424 First edition 2016-06-15.
13-95Health informatics—Personal health device communication—Part 10425: Device specialization—Continuous glucose monitor (CGM)ISO/IEEE 11073-10425 First edition 2016-06-15.
13-96Standard for Software Cybersecurity Network-Connectable Products, Part 1: General RequirementsUL 2900-1 Ed.1 2017.
13-97Health software—Part 1: General requirements for product safetyIEC 82304-1 Edition 1.0 2016-10.
R. Sterility
No new entries at this time.
Start Printed Page 39598
S. Tissue Engineering
15-50Standard Guide for Quantifying Cell Viability within Biomaterial ScaffoldsASTM F2739-16.
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. FDA will be incorporating 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 be announcing additional modifications and revisions to the list of recognized consensus standards in the Federal Register, as needed, once a year, or more often if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to CDRHStandardsStaff@fda.hhs.gov. To be 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 electronic or mailing address of the requestor, (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.

Start Signature

Dated: August 16, 2017.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2017-17603 Filed 8-18-17; 8:45 am]

BILLING CODE 4164-01-P