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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 051” (Recognition List Number: 051), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable March 14, 2019.

ADDRESSES:

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

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal: https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to

https://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on

https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

•

Mail/Hand Delivery/Courier (for written/paper submissions):

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the Docket No. FDA-2004-N-0451 for “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at

https://www.regulations.gov

or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 051.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on

https://www.regulations.gov.

Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:

http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to

https://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

An electronic copy of Recognition List Number: 051 is available on the internet

at

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 051 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 051” to Scott Colburn (see

FOR FURTHER INFORMATION CONTACT

). Send one self-addressed adhesive label to assist that office in processing your request or Fax your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT:

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

CDRHStandardsStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

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

In the

Federal Register

of September 14, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The guidance describes how FDA has implemented its standard recognition program and is available at

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf.

Modifications to the initial list of recognized standards, as published in the

Federal Register

, can be accessed at

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Additional information on the Agency's standards program is available at

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

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

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 051” to identify the current modifications.

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

In section III, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.

Table 1—Modifications to the List of Recognized Standards

Old

recognition

No.

Replacement

recognition

No.

Title of standard

1

Change

2

A. Anesthesiology

1-104

1-141

ISO 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.

1-108

ANSI/AAMI/ISO 5361:2012 Anaesthetic and respiratory equipment—Tracheal tubes and connectors

Withdrawn. See 1-118.

1-110

ANSI/AAMI/ISO 5366-1:2000 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adults

Withdrawn. See 1-117.

1-111

ANSI/AAMI/ISO 5366-3:2001 Anaesthetic and respiratory equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy Tubes

Withdrawn. See 1-117.

1-114

ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems—Draw-over Anaesthetic Systems

Extent of Recognition.

1-117

ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment—Tracheostomy tubes and connectors

Extent of Recognition.

1-118

ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment—Tracheal tubes and connectors

Extent of Recognition.

1-120

ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment—General requirements for airways and related equipment

Extent of Recognition.

1-138

ISO 80601-2-74 First edition 2017-05 Medical electrical equipment—Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

Extent of Recognition.

B. Biocompatibility

2-136

ASTM E1262-88 (Reapproved 2018) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

Reaffirmation.

2-141

ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

Reaffirmation.

2-145

ASTM F1439-03 (Reapproved 2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

Reaffirmation.

2-220

2-258

ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

Withdrawn and replaced with newer version.

2-251

2-259

USP 41-NF36:2018 <87> Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version.

2-252

2-260

USP 41-NF36:2018 <87> Biological Reactivity Test, In Vitro—Elution Test

Withdrawn and replaced with newer version.

2-253

2-261

USP 41-NF36:2018 <88> Biological Reactivity Test, In Vivo

Withdrawn and replaced with newer version.

2-254

2-262

USP 41-NF36:2018 <151> Pyrogen Test (USP Rabbit Test)

Withdrawn and replaced with newer version. Extent of Recognition.

C. Cardiovascular

3-44

AAMI BP22:1994 (R2016) Blood Pressure Transducers

Reaffirmation.

3-52

ANSI/AAMI EC12:2000/(R) 2015 Disposable ECG electrodes

Reaffirmation.

3-55

ASTM F1830-97 (Reapproved 2017) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps

Reaffirmation.

3-56

ASTM F1841-97 (Reapproved 2017) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

Reaffirmation. Extent of Recognition.

3-66

ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

Reaffirmation.

3-79

ASTM F2079-09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

Reaffirmation.

3-86

ASTM F2394-07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

Reaffirmation. Extent of Recognition.

3-99

AAMI TIR 42:2010 Evaluation of Particulates Associated with Vascular Medical Devices

Extent of Recognition.

3-122

IEC 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type

Extent of Recognition.

3-123

IEC 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 sphygmomanometers

Title change. Extent of recognition.

3-124

ISO 7199:2009 Cardiovascular implants and artificial organs—Blood gas exchangers (oxygenators)

Withdrawn.

3-126

IEC 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 equipment

Extent of recognition.

3-127

ANSI/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 systems

Reaffirmation.

3-138

ASTM F2942-13 Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents

Extent of Recognition.

3-142

ISO/TS 17137 First edition 2014-05-15 Cardiovascular implants and extracorporeal systems—Cardiovascular absorbable implants

Extent of Recognition.

D. Dental/Ear, Nose, and Throat (ENT)

4-126

4-248

ISO 10477 Third edition 2018-06 Dentistry—Polymer-based crown and veneering materials

Withdrawn and replaced with newer version.

4-150

4-249

ANSI/ADA Standard No. 19—2018 Elastomeric Impression Materials

Withdrawn and replaced with newer version.

4-162

ANSI S3.4-2007 (Reaffirmed 2017) American National Standard Procedure for the Computation of Loudness of Steady Sounds

Reaffirmation.

4-163

ANSI S3.5-1997 (Reaffirmed 2017) American National Standard Methods for Calculation of the Speech Intelligibility Index

Reaffirmation.

4-171

ANSI S3.37-1987 (Reaffirmed 2017) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids

Reaffirmation.

4-213

4-250

ISO 7494-1 Third edition 2018-06 Dentistry—Stationary dental units and dental patient chairs—Part 1: General requirements

Withdrawn and replaced with newer version.

4-217

ANSI/ASA S3.36-2012 (Reaffirmed 2018) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements

Reaffirmation.

4-223

4-251

ISO 6872 Fourth edition 2015-06-01 Dentistry—Ceramic materials [including AMENDMENT 1 2018-04]

Withdrawn and replaced with newer version including amendment.

4-226

4-252

ISO 10650 Second edition 2018-08 Dentistry—Powered polymerization activators

Withdrawn and replaced with newer version.

E. General I (Quality Systems/Risk Management) (QS/RM)

5-39

5-120

IEC 60812 Edition 3.0 2018-08 Failure modes and effects analysis (FMEA and FMECA)

Withdrawn and replaced with newer version. Title change.

5-63

5-121

ISO 80369-1 Second edition 2018-11 Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements

Withdrawn and replaced with newer version.

5-105

ISO 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 standards

Withdrawn.

F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)

19-13

19-32

IEC 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 systems

Withdrawn and replaced with newer version. Title change.

19-33

IEC 62133-2 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications—Part 2: Lithium systems

19-18

19-34

IEC 61010-1 Edition 3.1 2017-01 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirements

Withdrawn and replaced with newer version.

G. General Hospital/General Plastic Surgery (GH/GPS)

6-239

6-410

ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use—Part 6: Freeze drying closures for infusion bottles

Withdrawn and replaced with newer version.

6-338

ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves

Extent of recognition.

6-383

6-411

ASTM D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products

Withdrawn and replaced with newer version.

6-391

6-412

USP 41-NF36:2018 Sodium Chloride Irrigation

Withdrawn and replaced with newer version.

6-392

6-413

USP 41-NF36:2018 Sodium Chloride Injection

Withdrawn and replaced with newer version.

6-393

6-414

USP 41-NF36:2018 Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version.

6-394

6-415

USP 41-NF36:2018 <881> Tensile Strength

Withdrawn and replaced with newer version.

6-395

6-416

USP 41-NF36:2018 <861> Sutures—Diameter

Withdrawn and replaced with newer version.

6-396

6-417

USP 41-NF36:2018 <871> Sutures—Needle Attachment

Withdrawn and replaced with newer version.

6-397

6-418

USP 41-NF36:2018 Sterile Water for Irrigation

Withdrawn and replaced with newer version.

6-398

6-419

USP 41-NF36:2018 Heparin Lock Flush Solution

Withdrawn and replaced with newer version.

6-399

6-420

USP 41-NF36: 2018 Absorbable Surgical Suture

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-139

CLSI QMS24 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2. Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality

Title change.

7-178

CLSI M22-A3 Vol. 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition

Extent of recognition.

7-200

7-285

CLSI M48 2nd Edition Laboratory Detection and Identification of Mycobacteria

Withdrawn and replaced with a newer version.

7-215

CLSI 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 Edition

Extent of recognition.

7-222

CLSI M24-A2 (Replaces M24-A) Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes; Approved Standards—Second Edition

Extent of recognition.

7-228

7-286

CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria

Withdrawn and replaced with a newer version. Extent of recognition.

7-232

CLSI MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—Second Edition

Extent of recognition.

7-262

CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria

Extent of recognition.

7-269

CLSI MM23 1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)

Extent of recognition.

7-282

CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts

Withdrawn. Duplicate version.

I. Materials

8-179

ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

Extent of recognition.

8-335

8-480

ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

Withdrawn and replaced with newer version.

8-345

8-481

ASTM 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.

8-365

8-482

ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique

Withdrawn and replaced with newer version.

8-371

8-483

ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

Withdrawn and replaced with newer version.

8-375

8-484

ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

Withdrawn and replaced with newer version.

8-462

8-485

ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles

Withdrawn and replaced with newer version.

J. Nanotechnology

18-2

ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings

Reaffirmation.

18-5

ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy

Reaffirmation.

18-6

ASTM E2865-12 (Reapproved 2018) Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials

Reaffirmation.

18-7

ASTM E2834-12 (Reapproved 2018) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)

Reaffirmation.

18-8

ASTM E2578-07 (Reapproved 2018) Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions

Reaffirmation.

K. Neurology

17-14

ANSI/AAMI NS4:2013/(R) 2017 Transcutaneous electrical nerve stimulators

Reaffirmation.

L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)

9-68

ISO 23409 First edition 2011-02-15 Male Condoms—Requirements and test methods for condoms made from synthetic materials

Extent of Recognition.

9-80

9-121

IEC 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 equipment

Withdrawn and replaced with newer version.

9-89

ANSI AAMI ISO 8638:2010 (R2015) Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters

Reaffirmation.

9-93

9-122

ISO 25841 Third edition 2017-08 Female condoms—Requirements and test methods

Withdrawn and replaced with newer version.

9-111

ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms—Requirements and test methods

Extent of Recognition.

9-112

ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)

Extent of Recognition.

M. Ophthalmic

10-74

ISO 10940 Second edition 2009-08-01 Ophthalmic instruments—Fundus cameras

Extent of recognition.

10-85

ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigations

Title change. Extent of recognition.

10-86

ISO 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.

10-89

ANSI Z80.7-2013 (R2018) American National Standard for Ophthalmic Optics—Intraocular Lenses

Reaffirmation. Extent of recognition.

10-93

ANSI Z80.27-2014 American National Standard for Ophthalmics—Implantable Glaucoma Devices

Extent of recognition.

10-108

ISO 18369-2 Third Edition 2017-08 Ophthalmic optics—Contact lenses—Part 2: Tolerances

Extent of recognition.

N. Orthopedic

11-184

ISO 8827 First edition 1988-10-15 Implants for surgery—Staples with parallel legs for orthopaedic use—General requirements

Extent of Recognition.

11-234

11-342

ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

Withdrawn and replaced with newer version.

11-243

11-343

ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

Withdrawn and replaced with newer version.

11-272

ASTM F1714-96 (Reapproved 2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices

Reaffirmation.

11-295

11-344

ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

Withdrawn and replaced with newer version.

11-302

11-345

ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Withdrawn and replaced with newer version.

11-323

11-346

ASTM F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

Withdrawn and replaced with newer version.

11-331

11-347

ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices

Withdrawn and replaced with newer version.

O. Physical Medicine

16-29

16-204

ISO 7176-6 Third edition 2018-06 Wheelchairs—Part 6: Determination of maximum speed of electrically powered wheelchairs

Withdrawn and replaced with newer version.

16-202

16-205

RESNA WC-4:2017 Standard for Wheelchairs Volume 4: Wheelchairs and Transportation

Withdrawn and replaced with new recognition number.

P. Radiology

12-102

ANSI/IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement Techniques

Reaffirmation.

12-179

12-321

ANSI/IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and Labeling

Withdrawn and replaced with newer version.

12-231

12-322

NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging

Withdrawn and replaced with newer version.

12-247

12-323

ISO 11990 Third edition 2018-08 Lasers and laser-related equipment—Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs

Withdrawn and replaced with newer version. Title change.

12-305

12-324

ISO 13694 Third edition 2018-11 Optics and Photonics—Lasers and laser-related equipment—Test methods for laser beam power (energy) density distribution

Withdrawn and replaced with newer version.

Q. Software/Informatics

13-32

ANSI AAMI IEC 62304:2006 Medical device software—Software life cycle processes

Transition period.

13-79

IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software—Software life cycle processes

Title change and transition period.

R. Sterility

14-314

ANSI/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.

14-311

14-518

ANSI/AAMI ST55:2016 Table-top steam sterilizers

Withdrawn and replaced with newer version.

14-396

ANSI/AAMI ST77:2013/(R) 2018 Containment devices for reusable medical device sterilization

Reaffirmation.

14-410

14-519

ASTM F17-18 Standard Terminology Relating to Primary Barrier Packaging

Withdrawn and replaced with newer version.

14-503

14-520

USP 41-NF36:2018 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Withdrawn and replaced with newer version.

14-504

14-521

USP 41-NF36:2018 <71> Sterility Tests

Withdrawn and replaced with newer version.

14-505

14-522

USP 41-NF36:2018 <85> Bacterial Endotoxins Test

Withdrawn and replaced with newer version.

14-506

14-523

USP 41-NF36:2018 <161> Medical Devices—Bacterial Endotoxin and Pyrogen Tests

Withdrawn and replaced with newer version.

14-507

14-524

USP 41-NF36:2018 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

Withdrawn and replaced with newer version.

14-508

14-525

USP 41-NF36:2018 <55> Biological Indicators—Resistance Performance Tests

Withdrawn and replaced with newer version.

14-509

14-526

USP 41-NF36:2018 <1229.5> Biological Indicators for Sterilization

Withdrawn and replaced with newer version.

S. Tissue Engineering

15-47

ISO 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) agents

Extent 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

1

Reference No. and date

A. Anesthesiology

No new entries at this time.

B. Biocompatibility

No new entries at this time.

C. Cardiovascular

3-157

Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses

ANSI/AAMI/ISO 25539-1: 2017.

3-158

Standard Guide for Coating Characterization of Drug Coated Balloons

ASTM F3320-18.

3-159

Cardiovascular implants and extracorporeal systems—Cardiac valve repair devices

ISO 5910 First edition 2018-06.

D. Dental/Ear, Nose, and Throat (ENT)

4-253

Polymer-based Restorative Materials

ANSI/ADA Standard No. 27-2016.

4-254

Athletic Mouth Protectors and Materials

ANSI/ADA Standard No. 99-2001 (Reaffirmed 2013).

4-255

Dental CAD/CAM Machinable Zirconia Blanks

ANSI/ADA Standard No. 131-2015.

4-256

Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems

ANSI/ADA Standard No. 132-2015.

4-257

Dentistry—Fluoride varnishes

ISO 17730 First edition 2014-11-01.

E. General I (Quality Systems/Risk Management) (QS/RM)

5-122

Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices

ASME V&V 40-2018.

F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)

No new entries at this time.

G. General Hospital/General Plastic Surgery (GH/GPS)

No new entries at this time.

H. In Vitro Diagnostics (IVD)

No new entries at this time.

I. Materials

8-486

Standard Guide for in vitro Degradation Testing of Absorbable Metals

ASTM F3268-18.

8-487

Additive manufacturing—Design—Requirements, guidelines and recommendations

ISO/ASTM52910-18.

8-488

Standard for Additive Manufacturing—Post Processing Methods—Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion

ASTM F3301-18a.

8-489

Standard for Additive Manufacturing—Finished Part Properties—Standard Specification for Titanium Alloys via Powder Bed Fusion

ASTM F3302-18.

8-490

Standard for Additive Manufacturing—Process Characteristics and Performance: Practice for Metal Powder Bed Fusion Process to Meet Critical Applications

ASTM F3303-18.

J. Nanotechnology

18-11

Nanotechnologies—Nanomaterial risk evaluation

ISO/TR 13121 First edition 2011-05-15.

18-12

Nanotechnology—Nanoparticles in powder form—Characteristics and measurements

ISO/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

10-114

American National Standard for Ophthalmics—Methods of Reporting Optical Aberrations of Eyes

ANSI Z80.28-2017.

10-115

American National Standard for Ophthalmics—Accommodative Intraocular Lenses

ANSI Z80.29-2015.

N. Orthopedic

11-348

Implants for surgery—Cleanliness of orthopedic implants—General requirements

ISO 19227 First edition 2018-03.

O. Physical Medicine

16-206

Walking aids manipulated by both arms—Requirements and test methods—Part 2: Rollators

ISO 11199-2 Second edition 2005-04-15.

P. Radiology

No new entries at this time.

Q. Software/Informatics

13-105

Classification of defects in health software

ANSI/AAMI SW91:2018.

13-106

Health informatics—Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication

IEEE Std 11073-10207-2017.

13-107

Health informatics—Point-of-care medical device communication—Part 20702: Medical devices communication profile for web services

ISO/IEEE 11073-20702 First edition 2018-09.

R. Sterility

No new entries at this time.

S. Tissue Engineering

15-56

Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging

ASTM 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.

Dated: March 8, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.

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

BILLING CODE 4164-01-P