[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9354-9362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04710]
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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.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 051'' (Recognition List Number: 051), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable March 14, 2019.
ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 051.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will
consider any comments received in determining whether to amend the
current listing of modifications to the list of recognized standards,
Recognition List Number: 051.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 051 is available on
the internet
[[Page 9355]]
at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for electronic access to the
searchable database for the current list of FDA recognized consensus
standards, including Recognition List Number: 051 modifications and
other standards related information. Submit written requests for a
single hard copy of the document entitled ``Modifications to the List
of Recognized Standards, Recognition List Number: 051'' to Scott
Colburn (see FOR FURTHER INFORMATION CONTACT). Send one self-addressed
adhesive label to assist that office in processing your request or Fax
your request to 301-847-8144.
FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
allows FDA to recognize consensus standards developed by international
and national organizations for use in satisfying portions of device
premarket review submissions or other requirements.
In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standard
recognition program and is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. Modifications to the initial list of recognized
standards, as published in the Federal Register, can be accessed at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Additional information
on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 051
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 051'' to identify the current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change \2\
No.
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A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-104.............................. 1-141 ISO 80601-2-13 First edition 2011-08- Withdrawn and
11 Medical electrical equipment-- replaced with newer
Part 2-13: Particular requirements version including
for basic safety and essential amendment. Extent of
performance of an anaesthetic Recognition.
workstation [Including: AMENDMENT 1
(2015) and AMENDMENT 2 (2018)].
1-108.............................. .............. ANSI/AAMI/ISO 5361:2012 Anaesthetic Withdrawn. See 1-118.
and respiratory equipment--Tracheal
tubes and connectors.
1-110.............................. .............. ANSI/AAMI/ISO 5366-1:2000 Withdrawn. See 1-117.
Anaesthetic and respiratory
equipment--Tracheostomy tubes--Part
1: Tubes and connectors for use in
adults.
1-111.............................. .............. ANSI/AAMI/ISO 5366-3:2001 Withdrawn. See 1-117.
Anaesthetic and respiratory
equipment--Tracheostomy Tubes--Part
3: Paediatric Tracheostomy Tubes.
1-114.............................. .............. ISO 18835 First Edition 2015-04-01 Extent of
Inhalational Anaesthesia Systems-- Recognition.
Draw-over Anaesthetic Systems.
1-117.............................. .............. ISO 5366 First edition 2016-10-01 Extent of
Anaesthetic and respiratory Recognition.
equipment--Tracheostomy tubes and
connectors.
1-118.............................. .............. ISO 5361 Third edition 2016-09-01 Extent of
Anaesthetic and respiratory Recognition.
equipment--Tracheal tubes and
connectors.
1-120.............................. .............. ISO 18190 First edition 2016-11-01 Extent of
Anaesthetic and respiratory Recognition.
equipment--General requirements for
airways and related equipment.
1-138.............................. .............. ISO 80601-2-74 First edition 2017-05 Extent of
Medical electrical equipment--Part Recognition.
2-74: Particular requirements for
basic safety and essential
performance of respiratory
humidifying equipment.
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B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-136.............................. .............. ASTM E1262-88 (Reapproved 2018) Reaffirmation.
Standard Guide for Performance of
Chinese Hamster Ovary Cell/
Hypoxanthine Guanine Phosphoribosyl
Transferase Gene Mutation Assay.
2-141.............................. .............. ASTM F1984-99 (Reapproved 2018) Reaffirmation.
Standard Practice for Testing for
Whole Complement Activation in
Serum by Solid Materials.
[[Page 9356]]
2-145.............................. .............. ASTM F1439-03 (Reapproved 2018) Reaffirmation.
Standard Guide for Performance of
Lifetime Bioassay for the
Tumorigenic Potential of Implant
Materials.
2-220.............................. 2-258 ISO 10993-1 Fifth edition 2018-08 Withdrawn and
Biological evaluation of medical replaced with newer
devices--Part 1: Evaluation and version.
testing within a risk management
process.
2-251.............................. 2-259 USP 41-NF36:2018 <87> Biological Withdrawn and
Reactivity Test, In Vitro--Direct replaced with newer
Contact Test. version.
2-252.............................. 2-260 USP 41-NF36:2018 <87> Biological Withdrawn and
Reactivity Test, In Vitro--Elution replaced with newer
Test. version.
2-253.............................. 2-261 USP 41-NF36:2018 <88> Biological Withdrawn and
Reactivity Test, In Vivo. replaced with newer
version.
2-254.............................. 2-262 USP 41-NF36:2018 <151> Pyrogen Test Withdrawn and
(USP Rabbit Test). replaced with newer
version. Extent of
Recognition.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-44............................... .............. AAMI BP22:1994 (R2016) Blood Reaffirmation.
Pressure Transducers.
3-52............................... .............. ANSI/AAMI EC12:2000/(R) 2015 Reaffirmation.
Disposable ECG electrodes.
3-55............................... .............. ASTM F1830-97 (Reapproved 2017) Reaffirmation.
Standard Practice for Selection of
Blood for in vitro Evaluation of
Blood Pumps.
3-56............................... .............. ASTM F1841-97 (Reapproved 2017) Reaffirmation. Extent
Standard Practice for Assessment of of Recognition.
Hemolysis in Continuous Flow Blood
Pumps.
3-66............................... .............. ASTM F2081-06 (Reapproved 2017) Reaffirmation.
Standard Guide for Characterization
and Presentation of the Dimensional
Attributes of Vascular Stents.
3-79............................... .............. ASTM F2079-09 (Reapproved 2017) Reaffirmation.
Standard Test Method for Measuring
Intrinsic Elastic Recoil of Balloon-
Expandable Stents.
3-86............................... .............. ASTM F2394-07 (Reapproved 2017) Reaffirmation. Extent
Standard Guide for Measuring of Recognition.
Securement of Balloon Expandable
Vascular Stent Mounted on Delivery
System.
3-99............................... .............. AAMI TIR 42:2010 Evaluation of Extent of
Particulates Associated with Recognition.
Vascular Medical Devices.
3-122.............................. .............. IEC 81060-2 Second edition 2013-05- Extent of
01 Non-invasive sphygmomanometers-- Recognition.
Part 2: Clinical validation of
automated measurement type.
3-123.............................. .............. IEC 80601-2-30 Edition 2.0 2018-03 Title change. Extent
Medical electrical equipment--Part of recognition.
2-30: Particular requirements for
the basic safety and essential
performance of automated non-
invasive sphygmomanometers.
3-124.............................. .............. ISO 7199:2009 Cardiovascular Withdrawn.
implants and artificial organs--
Blood gas exchangers (oxygenators).
3-126.............................. .............. IEC 60601-2-27 Edition 3.0 2011-03 Extent of
Medical electrical equipment--Part recognition.
2-27: Particular requirements for
the basic safety and essential
performance of electrocardiographic
monitoring equipment.
3-127.............................. .............. ANSI/AAMI/IEC 60601-2-47:2012/(R) Reaffirmation.
2016 Medical electrical equipment--
Part 2-47: Particular requirements
for the basic safety and essential
performance of ambulatory
electrocardiographic systems.
3-138.............................. .............. ASTM F2942-13 Standard Guide for the Extent of
In Vitro Axial, Bending, and Recognition.
Rotational Durability Test of
Vascular Stents.
3-142.............................. .............. ISO/TS 17137 First edition 2014-05- Extent of
15 Cardiovascular implants and Recognition.
extracorporeal systems--
Cardiovascular absorbable implants.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-126.............................. 4-248 ISO 10477 Third edition 2018-06 Withdrawn and
Dentistry--Polymer-based crown and replaced with newer
veneering materials. version.
4-150.............................. 4-249 ANSI/ADA Standard No. 19--2018 Withdrawn and
Elastomeric Impression Materials. replaced with newer
version.
4-162.............................. .............. ANSI S3.4-2007 (Reaffirmed 2017) Reaffirmation.
American National Standard
Procedure for the Computation of
Loudness of Steady Sounds.
4-163.............................. .............. ANSI S3.5-1997 (Reaffirmed 2017) Reaffirmation.
American National Standard Methods
for Calculation of the Speech
Intelligibility Index.
4-171.............................. .............. ANSI S3.37-1987 (Reaffirmed 2017) Reaffirmation.
American National Standard
Preferred Earhook Nozzle Thread for
Postauricular Hearing Aids.
4-213.............................. 4-250 ISO 7494-1 Third edition 2018-06 Withdrawn and
Dentistry--Stationary dental units replaced with newer
and dental patient chairs--Part 1: version.
General requirements.
4-217.............................. .............. ANSI/ASA S3.36-2012 (Reaffirmed Reaffirmation.
2018) American National Standard
Specification for a Manikin for
Simulated in-situ Airborne Acoustic
Measurements.
4-223.............................. 4-251 ISO 6872 Fourth edition 2015-06-01 Withdrawn and
Dentistry--Ceramic materials replaced with newer
[including AMENDMENT 1 2018-04]. version including
amendment.
4-226.............................. 4-252 ISO 10650 Second edition 2018-08 Withdrawn and
Dentistry--Powered polymerization replaced with newer
activators. version.
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[[Page 9357]]
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-39............................... 5-120 IEC 60812 Edition 3.0 2018-08 Withdrawn and
Failure modes and effects analysis replaced with newer
(FMEA and FMECA). version. Title
change.
5-63............................... 5-121 ISO 80369-1 Second edition 2018-11 Withdrawn and
Small-bore connectors for liquids replaced with newer
and gases in healthcare version.
applications--Part 1: General
requirements.
5-105.............................. .............. ISO 16142-1 First edition 2016-03-01 Withdrawn.
Medical devices--Recognized
essential principles of safety and
performance of medical devices--
Part 1: General essential
principles and additional specific
essential principles for all non-
IVD medical devices and guidance on
selection of standards.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-13.............................. 19-32 IEC 62133-1 Edition 1.0 2017-02 Withdrawn and
Secondary cells and batteries replaced with newer
containing alkaline or other non- version. Title
acid electrolytes--Safety change.
requirements for portable sealed
secondary cells, and for batteries
made from them, for use in portable
applications--Part 1: Nickel
systems.
19-33 IEC 62133-2 Edition 1.0 2017-02
Secondary cells and batteries
containing alkaline or other non-
acid electrolytes--Safety
requirements for portable sealed
secondary cells, and for batteries
made from them, for use in portable
applications--Part 2: Lithium
systems.
19-18.............................. 19-34 IEC 61010-1 Edition 3.1 2017-01 Withdrawn and
Safety requirements for electrical replaced with newer
equipment for measurement, control, version.
and laboratory use--Part 1: General
requirements.
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-239.............................. 6-410 ISO 8536-6 Third edition 2016-12-01 Withdrawn and
Infusion equipment for medical use-- replaced with newer
Part 6: Freeze drying closures for version.
infusion bottles.
6-338.............................. .............. ASTM D7866-14 Standard Specification Extent of
for Radiation Attenuating recognition.
Protective Gloves.
6-383.............................. 6-411 ASTM D6499-18 Standard Test Method Withdrawn and
for Immunological Measurement of replaced with newer
Antigenic Protein in Hevea Natural version.
Rubber (HNR) and its Products.
6-391.............................. 6-412 USP 41-NF36:2018 Sodium Chloride Withdrawn and
Irrigation. replaced with newer
version.
6-392.............................. 6-413 USP 41-NF36:2018 Sodium Chloride Withdrawn and
Injection. replaced with newer
version.
6-393.............................. 6-414 USP 41-NF36:2018 Nonabsorbable Withdrawn and
Surgical Suture. replaced with newer
version.
6-394.............................. 6-415 USP 41-NF36:2018 <881> Tensile Withdrawn and
Strength. replaced with newer
version.
6-395.............................. 6-416 USP 41-NF36:2018 <861> Sutures-- Withdrawn and
Diameter. replaced with newer
version.
6-396.............................. 6-417 USP 41-NF36:2018 <871> Sutures-- Withdrawn and
Needle Attachment. replaced with newer
version.
6-397.............................. 6-418 USP 41-NF36:2018 Sterile Water for Withdrawn and
Irrigation. replaced with newer
version.
6-398.............................. 6-419 USP 41-NF36:2018 Heparin Lock Flush Withdrawn and
Solution. replaced with newer
version.
6-399.............................. 6-420 USP 41-NF36: 2018 Absorbable Withdrawn and
Surgical Suture. replaced with newer
version.
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H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-139.............................. .............. CLSI QMS24 3rd Edition September Title change.
2016 Replaces GP27-A2 and GP29-A2.
Using Proficiency Testing and
Alternative Assessment to Improve
Medical Laboratory Quality.
7-178.............................. .............. CLSI M22-A3 Vol. 24 No. 19 Replaces Extent of
M22-A2 Vol. 16 No. 16 Quality recognition.
Control for Commercially Prepared
Microbiological Culture Media;
Approved Standard--Third Edition.
7-200.............................. 7-285 CLSI M48 2nd Edition Laboratory Withdrawn and
Detection and Identification of replaced with a
Mycobacteria. newer version.
7-215.............................. .............. CLSI M44-A2 Vol. 29 No. 17 Replaces Extent of
MM44-A Vol. 24 No. 15 Method for recognition.
Antifungal Disk Diffusion
Susceptibility Testing of Yeast;
Approved Guideline--Second Edition.
7-222.............................. .............. CLSI M24-A2 (Replaces M24-A) Extent of
Susceptibility Testing of recognition.
Mycobacteria, Nocardiae and other
Aerobic Actinomycetes; Approved
Standards--Second Edition.
[[Page 9358]]
7-228.............................. 7-286 CLSI M11 9th Edition Methods for Withdrawn and
Antimicrobial Susceptibility replaced with a
Testing of Anaerobic Bacteria. newer version.
Extent of
recognition.
7-232.............................. .............. CLSI MM05-A2 Vol. 32 No. 6 Replaces Extent of
MM05-A Vol. 23 No. 17 Nucleic Acid recognition.
Amplification Assays for Molecular
Hematopathology; Approved
Guideline--Second Edition.
7-262.............................. .............. CLSI M45 3rd Edition Methods for Extent of
Antimicrobial Dilution and Disk recognition.
Susceptibility Testing of
Infrequently Isolated or Fastidious
Bacteria.
7-269.............................. .............. CLSI MM23 1st Edition Molecular Extent of
Diagnostic Methods for Solid Tumors recognition.
(Nonhematological Neoplasms).
7-282.............................. .............. CLSI M60 1st Edition Performance Withdrawn. Duplicate
Standards for Antifungal version.
Susceptibility Testing of Yeasts.
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I. Materials
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8-179.............................. .............. ASTM F754-08 (Reapproved 2015) Extent of
Standard Specification for recognition.
Implantable Polytetrafluoroethylene
(PTFE) Sheet, Tube, and Rod Shapes
Fabricated from Granular Molding
Powders.
8-335.............................. 8-480 ASTM F2063-18 Standard Specification Withdrawn and
for Wrought Nickel-Titanium Shape replaced with newer
Memory Alloys for Medical Devices version.
and Surgical Implants.
8-345.............................. 8-481 ASTM F1314-18 Standard Specification Withdrawn and
for Wrought Nitrogen Strengthened replaced with newer
22 Chromium--13 Nickel--5 version.
Manganese--2.5 Molybdenum Stainless
Steel Alloy Bar and Wire for
Surgical Implants (UNS S20910).
8-365.............................. 8-482 ASTM D1505-18 Standard Test Method Withdrawn and
for Density of Plastics by the replaced with newer
Density-Gradient Technique. version.
8-371.............................. 8-483 ASTM F601-18 Standard Practice for Withdrawn and
Fluorescent Penetrant Inspection of replaced with newer
Metallic Surgical Implants. version.
8-375.............................. 8-484 ASTM F2066-18 Standard Specification Withdrawn and
for Wrought Titanium-15 Molybdenum replaced with newer
Alloy for Surgical Implant version.
Applications (UNS R58150).
8-462.............................. 8-485 ASTM F3260-18 Standard Test Method Withdrawn and
for Determining the Flexural replaced with newer
Stiffness of Medical Textiles. version.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-2............................... .............. ASTM E2535-07 (Reapproved 2018) Reaffirmation.
Standard Guide for Handling Unbound
Engineered Nanoscale Particles in
Occupational Settings.
18-5............................... .............. ASTM E2859-11 (Reapproved 2017) Reaffirmation.
Standard Guide for Size Measurement
of Nanoparticles Using Atomic Force
Microscopy.
18-6............................... .............. ASTM E2865-12 (Reapproved 2018) Reaffirmation.
Standard Guide for Measurement of
Electrophoretic Mobility and Zeta
Potential of Nanosized Biological
Materials.
18-7............................... .............. ASTM E2834-12 (Reapproved 2018) Reaffirmation.
Standard Guide for Measurement of
Particle Size Distribution of
Nanomaterials in Suspension by
Nanoparticle Tracking Analysis
(NTA).
18-8............................... .............. ASTM E2578-07 (Reapproved 2018) Reaffirmation.
Standard Practice for Calculation
of Mean Sizes/Diameters and
Standard Deviations of Particle
Size Distributions.
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
17-14.............................. .............. ANSI/AAMI NS4:2013/(R) 2017 Reaffirmation.
Transcutaneous electrical nerve
stimulators.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-68............................... .............. ISO 23409 First edition 2011-02-15 Extent of
Male Condoms--Requirements and test Recognition.
methods for condoms made from
synthetic materials.
9-80............................... 9-121 IEC 60601-2-16 Edition 5.0 2018-04 Withdrawn and
Medical electrical equipment--Part replaced with newer
2-16: Particular requirements for version.
the basic safety and essential
performance of haemodialysis,
haemodiafiltration and
haemofiltration equipment.
9-89............................... .............. ANSI AAMI ISO 8638:2010 (R2015) Reaffirmation.
Cardiovascular implants and
extracorporeal systems--
Extracorporeal blood circuit for
hemodialyzers, hemodiafilters and
hemofilters.
9-93............................... 9-122 ISO 25841 Third edition 2017-08 Withdrawn and
Female condoms--Requirements and replaced with newer
test methods. version.
9-111.............................. .............. ISO 4074 Third edition 2015-10-15 Extent of
Natural latex rubber condoms-- Recognition.
Requirements and test methods.
9-112.............................. .............. ASTM D3492-16 Standard Specification Extent of
for Rubber Contraceptives (Male Recognition.
Condoms).
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-74.............................. .............. ISO 10940 Second edition 2009-08-01 Extent of
Ophthalmic instruments--Fundus recognition.
cameras.
[[Page 9359]]
10-85.............................. .............. ISO 11980 Third edition 2012-11-15 Title change. Extent
Corrected version 2012-12-01 of recognition.
Ophthalmic optics--Contact lenses
and contact lens care products--
Guidance for clinical
investigations.
10-86.............................. .............. ISO 14729 First edition 2001-04-15 Extent of
Ophthalmic optics--Contact lens recognition.
care products--Microbiological
requirements and test methods for
products and regimens for hygienic
management of contact lenses
[Including: Amendment 1 (2010)].
10-89.............................. .............. ANSI Z80.7-2013 (R2018) American Reaffirmation. Extent
National Standard for Ophthalmic of recognition.
Optics--Intraocular Lenses.
10-93.............................. .............. ANSI Z80.27-2014 American National Extent of
Standard for Ophthalmics-- recognition.
Implantable Glaucoma Devices.
10-108............................. .............. ISO 18369-2 Third Edition 2017-08 Extent of
Ophthalmic optics--Contact lenses-- recognition.
Part 2: Tolerances.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-184............................. .............. ISO 8827 First edition 1988-10-15 Extent of
Implants for surgery--Staples with Recognition.
parallel legs for orthopaedic use--
General requirements.
11-234............................. 11-342 ASTM F732-17 Standard Test Method Withdrawn and
for Wear Testing of Polymeric replaced with newer
Materials Used in Total Joint version.
Prostheses.
11-243............................. 11-343 ASTM F2346-18 Standard Test Methods Withdrawn and
for Static and Dynamic replaced with newer
Characterization of Spinal version.
Artificial Discs.
11-272............................. .............. ASTM F1714-96 (Reapproved 2018) Reaffirmation.
Standard Guide for Gravimetric Wear
Assessment of Prosthetic Hip
Designs in Simulator Devices.
11-295............................. 11-344 ASTM F2580-18 Standard Practice for Withdrawn and
Evaluation of Modular Connection of replaced with newer
Proximally Fixed Femoral Hip version.
Prosthesis.
11-302............................. 11-345 ASTM F1717-18 Standard Test Methods Withdrawn and
for Spinal Implant Constructs in a replaced with newer
Vertebrectomy Model. version.
11-323............................. 11-346 ASTM F2706-18 Standard Test Methods Withdrawn and
for Occipital-Cervical and replaced with newer
Occipital-Cervical-Thoracic Spinal version.
Implant Constructs in a
Vertebrectomy Model.
11-331............................. 11-347 ASTM F2077-18 Test Methods for Withdrawn and
Intervertebral Body Fusion Devices. replaced with newer
version.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-29.............................. 16-204 ISO 7176-6 Third edition 2018-06 Withdrawn and
Wheelchairs--Part 6: Determination replaced with newer
of maximum speed of electrically version.
powered wheelchairs.
16-202............................. 16-205 RESNA WC-4:2017 Standard for Withdrawn and
Wheelchairs Volume 4: Wheelchairs replaced with new
and Transportation. recognition number.
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-102............................. .............. ANSI/IES RP-27.2-00/R17 Recommended Reaffirmation.
Practice for Photobiological Safety
for Lamps and Lamp Systems--
Measurement Techniques.
12-179............................. 12-321 ANSI/IES RP-27.3-17 Recommended Withdrawn and
Practice for Photobiological Safety replaced with newer
for Lamps--Risk Group version.
Classification and Labeling.
12-231............................. 12-322 NEMA MS 5-2018 Determination of Withdrawn and
Slice Thickness in Diagnostic replaced with newer
Magnetic Resonance Imaging. version.
12-247............................. 12-323 ISO 11990 Third edition 2018-08 Withdrawn and
Lasers and laser-related equipment-- replaced with newer
Determination of laser resistance version. Title
of tracheal tube shaft and tracheal change.
tube cuffs.
12-305............................. 12-324 ISO 13694 Third edition 2018-11 Withdrawn and
Optics and Photonics--Lasers and replaced with newer
laser-related equipment--Test version.
methods for laser beam power
(energy) density distribution.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-32.............................. .............. ANSI AAMI IEC 62304:2006 Medical Transition period.
device software--Software life
cycle processes.
13-79.............................. .............. IEC 62304 Edition 1.1 2015-06 Title change and
CONSOLIDATED VERSION Medical device transition period.
software--Software life cycle
processes.
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-314............................. .............. ANSI/AAMI ST67:2011/(R) 2017 Reaffirmation.
Sterilization of health care
products--Requirements and guidance
for selecting a sterility assurance
level (SAL) for products labeled
`sterile'.
14-311............................. 14-518 ANSI/AAMI ST55:2016 Table-top steam Withdrawn and
sterilizers. replaced with newer
version.
14-396............................. .............. ANSI/AAMI ST77:2013/(R) 2018 Reaffirmation.
Containment devices for reusable
medical device sterilization.
[[Page 9360]]
14-410............................. 14-519 ASTM F17-18 Standard Terminology Withdrawn and
Relating to Primary Barrier replaced with newer
Packaging. version.
14-503............................. 14-520 USP 41-NF36:2018 <61> Withdrawn and
Microbiological Examination of replaced with newer
Nonsterile Products: Microbial version.
Enumeration Tests.
14-504............................. 14-521 USP 41-NF36:2018 <71> Sterility Withdrawn and
Tests. replaced with newer
version.
14-505............................. 14-522 USP 41-NF36:2018 <85> Bacterial Withdrawn and
Endotoxins Test. replaced with newer
version.
14-506............................. 14-523 USP 41-NF36:2018 <161> Medical Withdrawn and
Devices--Bacterial Endotoxin and replaced with newer
Pyrogen Tests. version.
14-507............................. 14-524 USP 41-NF36:2018 <62> Withdrawn and
Microbiological Examination of replaced with newer
Nonsterile Products: Tests for version.
Specified Microorganisms.
14-508............................. 14-525 USP 41-NF36:2018 <55> Biological Withdrawn and
Indicators--Resistance Performance replaced with newer
Tests. version.
14-509............................. 14-526 USP 41-NF36:2018 <1229.5> Biological Withdrawn and
Indicators for Sterilization. replaced with newer
version.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-47.............................. .............. ISO 22442-3 First edition 2007-12-15 Extent of
Medical devices utilizing animal Recognition.
tissues and their derivatives--Part
3: Validation of the elimination
and/or inactivation of viruses and
transmissible spongiform
encephalopathy (TSE) agents.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
\2\ Standards that are ``Withdrawn'' or ``Withdrawn and replaced with newer version'' will have a transition
period with an expiration date as noted in the recognition database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
III. Listing of New Entries
In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 051.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No.
Recognition No. Title of standard \1\ and date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-157......................... Cardiovascular ANSI/AAMI/ISO
implants--Endovascula 25539-1: 2017.
r devices--Part 1:
Endovascular
prostheses.
3-158......................... Standard Guide for ASTM F3320-18.
Coating
Characterization of
Drug Coated Balloons.
3-159......................... Cardiovascular ISO 5910 First
implants and edition 2018-
extracorporeal 06.
systems--Cardiac
valve repair devices.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-253......................... Polymer-based ANSI/ADA
Restorative Materials. Standard No. 27-
2016.
4-254......................... Athletic Mouth ANSI/ADA
Protectors and Standard No. 99-
Materials. 2001
(Reaffirmed
2013).
4-255......................... Dental CAD/CAM ANSI/ADA
Machinable Zirconia Standard No.
Blanks. 131-2015.
4-256......................... Scanning Accuracy of ANSI/ADA
Dental Chairside and Standard No.
Laboratory CAD/CAM 132-2015.
Systems.
4-257......................... Dentistry--Fluoride ISO 17730 First
varnishes. edition 2014-11-
01.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-122......................... Assessing Credibility ASME V&V 40-
of Computational 2018.
Modeling Through
Verification and
Validation:
Application to
Medical Devices.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
[[Page 9361]]
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-486......................... Standard Guide for in ASTM F3268-18.
vitro Degradation
Testing of Absorbable
Metals.
8-487......................... Additive ISO/ASTM52910-
manufacturing--Design 18.
-Requirements,
guidelines and
recommendations.
8-488......................... Standard for Additive ASTM F3301-18a.
Manufacturing--Post
Processing Methods--
Standard
Specification for
Thermal Post-
Processing Metal
Parts Made Via Powder
Bed Fusion.
8-489......................... Standard for Additive ASTM F3302-18.
Manufacturing--Finish
ed Part Properties--
Standard
Specification for
Titanium Alloys via
Powder Bed Fusion.
8-490......................... Standard for Additive ASTM F3303-18.
Manufacturing--Proces
s Characteristics and
Performance: Practice
for Metal Powder Bed
Fusion Process to
Meet Critical
Applications.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-11......................... Nanotechnologies--Nano ISO/TR 13121
material risk First edition
evaluation. 2011-05-15.
18-12......................... Nanotechnology--Nanopa ISO/TS 17200
rticles in powder First edition
form--Characteristics 2013-06-01.
and measurements.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-114........................ American National ANSI Z80.28-
Standard for 2017.
Ophthalmics--Methods
of Reporting Optical
Aberrations of Eyes.
10-115........................ American National ANSI Z80.29-
Standard for 2015.
Ophthalmics--Accommod
ative Intraocular
Lenses.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-348........................ Implants for surgery-- ISO 19227 First
Cleanliness of edition 2018-
orthopedic implants-- 03.
General requirements.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-206........................ Walking aids ISO 11199-2
manipulated by both Second edition
arms--Requirements 2005-04-15.
and test methods--
Part 2: Rollators.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-105........................ Classification of ANSI/AAMI
defects in health SW91:2018.
software.
13-106........................ Health informatics-- IEEE Std 11073-
Point-of-care medical 10207-2017.
device communication
Part 10207: Domain
Information and
Service Model for
Service-Oriented
Point-of-Care Medical
Device Communication.
13-107........................ Health informatics-- ISO/IEEE 11073-
Point-of-care medical 20702 First
device communication-- edition 2018-
Part 20702: Medical 09.
devices communication
profile for web
services.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
No new entries at this
time..
------------------------------------------------------------------------
[[Page 9362]]
S. Tissue Engineering
------------------------------------------------------------------------
15-56......................... Standard Test Method ASTM F3224-17.
for Evaluating Growth
of Engineered
Cartilage Tissue
using Magnetic
Resonance Imaging.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with list 52, FDA will no longer announce in the Federal
Register updates to current recognized standards for reapproved or
reaffirmed standards because reapproved or reaffirmed standards have
not changed from the recognized standard. International and national
standards developing organizations use the designations of reapproved
or reaffirmed to indicate a standard has been reviewed but no changes
were made to the standard at that time.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. 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