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Notice

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

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 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 Start Printed Page 9355at 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.

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 (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

Old recognition No.Replacement recognition No.Title of standard 1Change 2
A. Anesthesiology
1-1041-141ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment—Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: AMENDMENT 1 (2015) and AMENDMENT 2 (2018)]Withdrawn and replaced with newer version including amendment. Extent of Recognition.
1-108ANSI/AAMI/ISO 5361:2012 Anaesthetic and respiratory equipment—Tracheal tubes and connectorsWithdrawn. See 1-118.
1-110ANSI/AAMI/ISO 5366-1:2000 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adultsWithdrawn. See 1-117.
1-111ANSI/AAMI/ISO 5366-3:2001 Anaesthetic and respiratory equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy TubesWithdrawn. See 1-117.
1-114ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems—Draw-over Anaesthetic SystemsExtent of Recognition.
1-117ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment—Tracheostomy tubes and connectorsExtent of Recognition.
1-118ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment—Tracheal tubes and connectorsExtent of Recognition.
1-120ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment—General requirements for airways and related equipmentExtent of Recognition.
1-138ISO 80601-2-74 First edition 2017-05 Medical electrical equipment—Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipmentExtent of Recognition.
B. Biocompatibility
2-136ASTM E1262-88 (Reapproved 2018) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation AssayReaffirmation.
2-141ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid MaterialsReaffirmation.
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2-145ASTM F1439-03 (Reapproved 2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant MaterialsReaffirmation.
2-2202-258ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management processWithdrawn and replaced with newer version.
2-2512-259USP 41-NF36:2018 <87> Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version.
2-2522-260USP 41-NF36:2018 <87> Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version.
2-2532-261USP 41-NF36:2018 <88> Biological Reactivity Test, In VivoWithdrawn and replaced with newer version.
2-2542-262USP 41-NF36:2018 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version. Extent of Recognition.
C. Cardiovascular
3-44AAMI BP22:1994 (R2016) Blood Pressure TransducersReaffirmation.
3-52ANSI/AAMI EC12:2000/(R) 2015 Disposable ECG electrodesReaffirmation.
3-55ASTM F1830-97 (Reapproved 2017) Standard Practice for Selection of Blood for in vitro Evaluation of Blood PumpsReaffirmation.
3-56ASTM F1841-97 (Reapproved 2017) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood PumpsReaffirmation. Extent of Recognition.
3-66ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular StentsReaffirmation.
3-79ASTM F2079-09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable StentsReaffirmation.
3-86ASTM F2394-07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery SystemReaffirmation. Extent of Recognition.
3-99AAMI TIR 42:2010 Evaluation of Particulates Associated with Vascular Medical DevicesExtent of Recognition.
3-122IEC 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement typeExtent of Recognition.
3-123IEC 80601-2-30 Edition 2.0 2018-03 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersTitle change. Extent of recognition.
3-124ISO 7199:2009 Cardiovascular implants and artificial organs—Blood gas exchangers (oxygenators)Withdrawn.
3-126IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentExtent of recognition.
3-127ANSI/AAMI/IEC 60601-2-47:2012/(R) 2016 Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systemsReaffirmation.
3-138ASTM F2942-13 Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular StentsExtent of Recognition.
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)
4-1264-248ISO 10477 Third edition 2018-06 Dentistry—Polymer-based crown and veneering materialsWithdrawn and replaced with newer version.
4-1504-249ANSI/ADA Standard No. 19—2018 Elastomeric Impression MaterialsWithdrawn and replaced with newer version.
4-162ANSI S3.4-2007 (Reaffirmed 2017) American National Standard Procedure for the Computation of Loudness of Steady SoundsReaffirmation.
4-163ANSI S3.5-1997 (Reaffirmed 2017) American National Standard Methods for Calculation of the Speech Intelligibility IndexReaffirmation.
4-171ANSI S3.37-1987 (Reaffirmed 2017) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing AidsReaffirmation.
4-2134-250ISO 7494-1 Third edition 2018-06 Dentistry—Stationary dental units and dental patient chairs—Part 1: General requirementsWithdrawn and replaced with newer version.
4-217ANSI/ASA S3.36-2012 (Reaffirmed 2018) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic MeasurementsReaffirmation.
4-2234-251ISO 6872 Fourth edition 2015-06-01 Dentistry—Ceramic materials [including AMENDMENT 1 2018-04]Withdrawn and replaced with newer version including amendment.
4-2264-252ISO 10650 Second edition 2018-08 Dentistry—Powered polymerization activatorsWithdrawn and replaced with newer version.
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E. General I (Quality Systems/Risk Management) (QS/RM)
5-395-120IEC 60812 Edition 3.0 2018-08 Failure modes and effects analysis (FMEA and FMECA)Withdrawn and replaced with newer version. Title change.
5-635-121ISO 80369-1 Second edition 2018-11 Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirementsWithdrawn and replaced with newer version.
5-105ISO 16142-1 First edition 2016-03-01 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 standardsWithdrawn.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19-1319-32IEC 62133-1 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 1: Nickel systemsWithdrawn and replaced with newer version. Title change.
19-33IEC 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
19-1819-34IEC 61010-1 Edition 3.1 2017-01 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirementsWithdrawn and replaced with newer version.
G. General Hospital/General Plastic Surgery (GH/GPS)
6-2396-410ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use—Part 6: Freeze drying closures for infusion bottlesWithdrawn and replaced with newer version.
6-338ASTM D7866-14 Standard Specification for Radiation Attenuating Protective GlovesExtent of recognition.
6-3836-411ASTM D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its ProductsWithdrawn and replaced with newer version.
6-3916-412USP 41-NF36:2018 Sodium Chloride IrrigationWithdrawn and replaced with newer version.
6-3926-413USP 41-NF36:2018 Sodium Chloride InjectionWithdrawn and replaced with newer version.
6-3936-414USP 41-NF36:2018 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version.
6-3946-415USP 41-NF36:2018 <881> Tensile StrengthWithdrawn and replaced with newer version.
6-3956-416USP 41-NF36:2018 <861> Sutures—DiameterWithdrawn and replaced with newer version.
6-3966-417USP 41-NF36:2018 <871> Sutures—Needle AttachmentWithdrawn and replaced with newer version.
6-3976-418USP 41-NF36:2018 Sterile Water for IrrigationWithdrawn and replaced with newer version.
6-3986-419USP 41-NF36:2018 Heparin Lock Flush SolutionWithdrawn and replaced with newer version.
6-3996-420USP 41-NF36: 2018 Absorbable Surgical SutureWithdrawn and replaced with newer version.
H. In Vitro Diagnostics (IVD)
7-139CLSI QMS24 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2. Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory QualityTitle change.
7-178CLSI M22-A3 Vol. 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third EditionExtent of recognition.
7-2007-285CLSI M48 2nd Edition Laboratory Detection and Identification of MycobacteriaWithdrawn and replaced with a newer version.
7-215CLSI M44-A2 Vol. 29 No. 17 Replaces MM44-A Vol. 24 No. 15 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeast; Approved Guideline—Second EditionExtent of recognition.
7-222CLSI M24-A2 (Replaces M24-A) Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes; Approved Standards—Second EditionExtent of recognition.
Start Printed Page 9358
7-2287-286CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic BacteriaWithdrawn and replaced with a newer version. Extent of recognition.
7-232CLSI MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—Second EditionExtent of recognition.
7-262CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious BacteriaExtent of recognition.
7-269CLSI MM23 1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)Extent of recognition.
7-282CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Testing of YeastsWithdrawn. Duplicate version.
I. Materials
8-179ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding PowdersExtent of recognition.
8-3358-480ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical ImplantsWithdrawn and replaced with newer version.
8-3458-481ASTM F1314-18 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium—13 Nickel—5 Manganese—2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)Withdrawn and replaced with newer version.
8-3658-482ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient TechniqueWithdrawn and replaced with newer version.
8-3718-483ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsWithdrawn and replaced with newer version.
8-3758-484ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)Withdrawn and replaced with newer version.
8-4628-485ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical TextilesWithdrawn and replaced with newer version.
J. Nanotechnology
18-2ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational SettingsReaffirmation.
18-5ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force MicroscopyReaffirmation.
18-6ASTM E2865-12 (Reapproved 2018) Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological MaterialsReaffirmation.
18-7ASTM E2834-12 (Reapproved 2018) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)Reaffirmation.
18-8ASTM E2578-07 (Reapproved 2018) Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size DistributionsReaffirmation.
K. Neurology
17-14ANSI/AAMI NS4:2013/(R) 2017 Transcutaneous electrical nerve stimulatorsReaffirmation.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9-68ISO 23409 First edition 2011-02-15 Male Condoms—Requirements and test methods for condoms made from synthetic materialsExtent of Recognition.
9-809-121IEC 60601-2-16 Edition 5.0 2018-04 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipmentWithdrawn and replaced with newer version.
9-89ANSI AAMI ISO 8638:2010 (R2015) Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofiltersReaffirmation.
9-939-122ISO 25841 Third edition 2017-08 Female condoms—Requirements and test methodsWithdrawn and replaced with newer version.
9-111ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms—Requirements and test methodsExtent of Recognition.
9-112ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)Extent of Recognition.
M. Ophthalmic
10-74ISO 10940 Second edition 2009-08-01 Ophthalmic instruments—Fundus camerasExtent of recognition.
Start Printed Page 9359
10-85ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigationsTitle change. Extent of recognition.
10-86ISO 14729 First edition 2001-04-15 Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010)]Extent of recognition.
10-89ANSI Z80.7-2013 (R2018) American National Standard for Ophthalmic Optics—Intraocular LensesReaffirmation. Extent of recognition.
10-93ANSI Z80.27-2014 American National Standard for Ophthalmics—Implantable Glaucoma DevicesExtent of recognition.
10-108ISO 18369-2 Third Edition 2017-08 Ophthalmic optics—Contact lenses—Part 2: TolerancesExtent of recognition.
N. Orthopedic
11-184ISO 8827 First edition 1988-10-15 Implants for surgery—Staples with parallel legs for orthopaedic use—General requirementsExtent of Recognition.
11-23411-342ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint ProsthesesWithdrawn and replaced with newer version.
11-24311-343ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial DiscsWithdrawn and replaced with newer version.
11-272ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator DevicesReaffirmation.
11-29511-344ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip ProsthesisWithdrawn and replaced with newer version.
11-30211-345ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelWithdrawn and replaced with newer version.
11-32311-346ASTM F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy ModelWithdrawn and replaced with newer version.
11-33111-347ASTM F2077-18 Test Methods for Intervertebral Body Fusion DevicesWithdrawn and replaced with newer version.
O. Physical Medicine
16-2916-204ISO 7176-6 Third edition 2018-06 Wheelchairs—Part 6: Determination of maximum speed of electrically powered wheelchairsWithdrawn and replaced with newer version.
16-20216-205RESNA WC-4:2017 Standard for Wheelchairs Volume 4: Wheelchairs and TransportationWithdrawn and replaced with new recognition number.
P. Radiology
12-102ANSI/IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement TechniquesReaffirmation.
12-17912-321ANSI/IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and LabelingWithdrawn and replaced with newer version.
12-23112-322NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance ImagingWithdrawn and replaced with newer version.
12-24712-323ISO 11990 Third edition 2018-08 Lasers and laser-related equipment—Determination of laser resistance of tracheal tube shaft and tracheal tube cuffsWithdrawn and replaced with newer version. Title change.
12-30512-324ISO 13694 Third edition 2018-11 Optics and Photonics—Lasers and laser-related equipment—Test methods for laser beam power (energy) density distributionWithdrawn and replaced with newer version.
Q. Software/Informatics
13-32ANSI AAMI IEC 62304:2006 Medical device software—Software life cycle processesTransition period.
13-79IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software—Software life cycle processesTitle change and transition period.
R. Sterility
14-314ANSI/AAMI ST67:2011/(R) 2017 Sterilization of health care products Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled `sterile'Reaffirmation.
14-31114-518ANSI/AAMI ST55:2016 Table-top steam sterilizersWithdrawn and replaced with newer version.
14-396ANSI/AAMI ST77:2013/(R) 2018 Containment devices for reusable medical device sterilizationReaffirmation.
Start Printed Page 9360
14-41014-519ASTM F17-18 Standard Terminology Relating to Primary Barrier PackagingWithdrawn and replaced with newer version.
14-50314-520USP 41-NF36:2018 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version.
14-50414-521USP 41-NF36:2018 <71> Sterility TestsWithdrawn and replaced with newer version.
14-50514-522USP 41-NF36:2018 <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version.
14-50614-523USP 41-NF36:2018 <161> Medical Devices—Bacterial Endotoxin and Pyrogen TestsWithdrawn and replaced with newer version.
14-50714-524USP 41-NF36:2018 <62> Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsWithdrawn and replaced with newer version.
14-50814-525USP 41-NF36:2018 <55> Biological Indicators—Resistance Performance TestsWithdrawn and replaced with newer version.
14-50914-526USP 41-NF36:2018 <1229.5> Biological Indicators for SterilizationWithdrawn and replaced with newer version.
S. Tissue Engineering
15-47ISO 22442-3 First edition 2007-12-15 Medical devices utilizing animal tissues and their derivatives—Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agentsExtent of Recognition.
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

Recognition No.Title of standard 1Reference No. and date
A. Anesthesiology
No new entries at this time.
B. Biocompatibility
No new entries at this time.
C. Cardiovascular
3-157Cardiovascular implants—Endovascular devices—Part 1: Endovascular prosthesesANSI/AAMI/ISO 25539-1: 2017.
3-158Standard Guide for Coating Characterization of Drug Coated BalloonsASTM F3320-18.
3-159Cardiovascular implants and extracorporeal systems—Cardiac valve repair devicesISO 5910 First edition 2018-06.
D. Dental/Ear, Nose, and Throat (ENT)
4-253Polymer-based Restorative MaterialsANSI/ADA Standard No. 27-2016.
4-254Athletic Mouth Protectors and MaterialsANSI/ADA Standard No. 99-2001 (Reaffirmed 2013).
4-255Dental CAD/CAM Machinable Zirconia BlanksANSI/ADA Standard No. 131-2015.
4-256Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM SystemsANSI/ADA Standard No. 132-2015.
4-257Dentistry—Fluoride varnishesISO 17730 First edition 2014-11-01.
E. General I (Quality Systems/Risk Management) (QS/RM)
5-122Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical DevicesASME V&V 40-2018.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
Start Printed 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
8-486Standard Guide for in vitro Degradation Testing of Absorbable MetalsASTM F3268-18.
8-487Additive manufacturing—Design—Requirements, guidelines and recommendationsISO/ASTM52910-18.
8-488Standard for Additive Manufacturing—Post Processing Methods—Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed FusionASTM F3301-18a.
8-489Standard for Additive Manufacturing—Finished Part Properties—Standard Specification for Titanium Alloys via Powder Bed FusionASTM F3302-18.
8-490Standard for Additive Manufacturing—Process Characteristics and Performance: Practice for Metal Powder Bed Fusion Process to Meet Critical ApplicationsASTM F3303-18.
J. Nanotechnology
18-11Nanotechnologies—Nanomaterial risk evaluationISO/TR 13121 First edition 2011-05-15.
18-12Nanotechnology—Nanoparticles in powder form—Characteristics and measurementsISO/TS 17200 First edition 2013-06-01.
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
10-114American National Standard for Ophthalmics—Methods of Reporting Optical Aberrations of EyesANSI Z80.28-2017.
10-115American National Standard for Ophthalmics—Accommodative Intraocular LensesANSI Z80.29-2015.
N. Orthopedic
11-348Implants for surgery—Cleanliness of orthopedic implants—General requirementsISO 19227 First edition 2018-03.
O. Physical Medicine
16-206Walking aids manipulated by both arms—Requirements and test methods—Part 2: RollatorsISO 11199-2 Second edition 2005-04-15.
P. Radiology
No new entries at this time.
Q. Software/Informatics
13-105Classification of defects in health softwareANSI/AAMI SW91:2018.
13-106Health informatics—Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device CommunicationIEEE Std 11073-10207-2017.
13-107Health informatics—Point-of-care medical device communication—Part 20702: Medical devices communication profile for web servicesISO/IEEE 11073-20702 First edition 2018-09.
R. Sterility
No new entries at this time.
Start Printed Page 9362
S. Tissue Engineering
15-56Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance ImagingASTM F3224-17.
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.

Start Signature

Dated: March 8, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2019-04710 Filed 3-13-19; 8:45 am]

BILLING CODE 4164-01-P