[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4274-4280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01420]
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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: 038
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 038'' (Recognition List Number: 038), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments concerning this
document at any time. See section VII of this document for the
effective date of the recognition of standards announced in this
document.
ADDRESSES: An electronic copy of Recognition List Number: 038 is
available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 038 modifications and other standards related
information.
Submit written requests for a single copy of the document entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 038'' to the Division of Industry and Consumer Education,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149.
Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring,
[[Page 4275]]
MD 20993, 301-796-6287, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Both versions are
publicly accessible at the Agency's Internet site. See section VI for
electronic access information. Interested persons should review the
supplementary information sheet for the standard to understand fully
the extent to which FDA recognizes the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 038
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. FDA
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 038'' to identify these current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.
Table 1--Modifications to the List of Recognized Standards
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Replacement
Old recognition No. recognition No. Title of standard \1\ Change
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A. Anesthesia
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1-57............................ ................ ASTM F1101-90 (Reapproved 2003) Withdrawn.
Standard Specification for
Ventilators Intended for Use
During Anesthesia.
1-69............................ ................ ASTM F1464-93 (Reapproved 2005) Withdrawn.
Standard Specification for
Oxygen Concentrators for
Domiciliary Use.
1-70............................ ................ ASTM F1246-91 (Reapproved 2005) Withdrawn.
Standard Specification for
Electrically Powered Home Care
Ventilators--Part 1: Positive-
Pressure Ventilators and
Ventilator Circuits.
1-94............................ ................ ISO 8359 Second edition 1996-12- Withdrawn. See 1-102.
15, Oxygen concentrators for
medical use--safety
requirements [including
amendment 1 (2012)].
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B. Biocompatibility
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2-143........................... 2-213 ASTM F1904-14 Standard Practice Withdrawn and replaced
for the Biological Responses to with newer version.
Particles in vivo.
2-144........................... 2-214 ASTM F619-14 Standard Practice Withdrawn and replaced
for Extraction of Medical with newer version.
Plastics.
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C. Cardiovascular
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3-88............................ ................ ASTM F2514-08 (Reapproved 2014) Reaffirmation.
Standard Guide for Finite
Element Analysis (FEA) of
Metallic Vascular Stents
Subjected to Uniform Radial
Loading.
3-123........................... ................ IEC 80601-2-30 Edition 1.1 2013- Extent of recognition and
07, Medical electrical Process impacted.
equipment--Part 2-30:
Particular requirements for the
basic safety and essential
performance of automated non-
invasive sphygmomanometers.
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D. Dental/ENT
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4-117........................... ................ ANSI/ADA Specification No. 12: Withdrawn.
2002 (Reaffirmed 2008) Denture
base polymers.
4-134........................... 4-213 ISO 7494-1 Second edition 2011- Withdrawn and replaced
08-15 Dentistry--Dental units-- with newer version.
Part 1: General requirements
and test methods.
4-135........................... 4-214 ISO 10139-1 Second edition 2005- Withdrawn and replaced
02-15, Dentistry--Soft lining with newer version
materials for removable including technical
dentures--Part 1: Materials for corrigendum.
short-term use [Including:
Technical Corrigendum 1 (2006)].
4-136........................... ................ ASTM F2504-05 (Reapproved 2014) Reaffirmation.
Standard Practice for
Describing System Output of
Implantable Middle Ear Hearing
Devices.
[[Page 4276]]
4-143........................... 4-215 ANSI/ADA Standard No. 96: 2012 Withdrawn and replaced
Dental Water-based Cements. with newer version.
4-159........................... 4-216 ANSI/IEEE ANSI C63.19-2011 Withdrawn and replaced
American National Standard with newer version.
Methods of Measurement of
Compatibility between Wireless
Communications Devices and
Hearing Aids.
4-170........................... 4-217 ANSI/ASA S3.36-2012 American Withdrawn and replaced
National Standard Specification with newer version.
for a Manikin for Simulated in-
situ Airborne Acoustic
Measurements.
4-183........................... ................ ANSI/ASA S3.2-2009 (Reaffirmed Reaffirmation.
2014) American National
Standard Method for Measuring
the Intelligibility of Speech
over Communication Systems.
4-185........................... ................ ANSI/ASA S3.45-2009 (Reaffirmed Reaffirmation.
2014) American National
Standard Procedures for Testing
Basic Vestibular Function.
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E. General I (Quality Systems/Risk Management (QS/RM))
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5-48............................ ................ ANSI/ASQ Z1.9-2003 (R2013) Reaffirmation.
Sampling Procedures and Tables
for Inspection by Variables for
Percent Nonconforming.
5-57............................ ................ ANSI/AAMI HE75:2009/(R)2013 Reaffirmation.
Human factors engineering--
Design of medical devices.
5-62............................ ................ ANSI/ASQ Z1.4-2003 (R2013) Reaffirmation.
Sampling Procedures and Tables
for Inspection by Attributes.
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F. General Hospital/General Plastic Surgery (GH/GPS)
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6-199........................... 6-335 ASTM F2101-14 Standard Test Withdrawn and replaced
Method for Evaluating the with newer version.
Bacterial Filtration Efficiency
(BFE) of Medical Face Mask
Materials, Using a Biological
Aerosol of Staphylococcus
aureus.
6-217........................... ................ ASTM F1670/F1670M-08 (Reapproved Reaffirmation.
2014)\[epsiv]1\ Standard Test
Method for Resistance of
Materials Used in Protective
Clothing to Penetration by
Synthetic Blood.
6-228........................... 6-336 IEC 60601-2-2 Edition 5.0 2009- Withdrawn and replaced
02 Medical Electrical with newer version
Equipment--Part 2-2: Particular including technical
Requirements for the Basic corrigendum.
Safety and Essential
Performance of High Frequency
Surgical Equipment and High
Frequency Surgical Accessories
[Including: Technical
Corrigendum 1 (2014)].
6-231........................... 6-337 ANSI/AAMI/IEC 60601-2-20:2009 Withdrawn and replaced
Medical Electrical Equipment-- with newer version
Part 2-20: Particular including erratum.
Requirements for the Basic
Safety and Essential
Performance of Infant Transport
Incubators [Including: Erratum
(2012)].
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G. In Vitro Diagnostics (IVD)
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7-84............................ ................ CEN 13640, Stability Testing of Withdrawn.
In Vitro Diagnostic Reagents.
7-162........................... ................ CLSI POCT14-A (Formerly H49-A) Withdrawn duplicate. See 7-
Point-Of-Care Monitoring of 112.
Anticoagulation Therapy;
Approved Guideline.
7-184........................... 7-250 CLSI M40-A2 Quality Control of Withdrawn and replaced
Microbiological Transport with newer version.
Systems; Approved Standard--
Second Edition.
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H. Materials
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8-111........................... 8-380 ASTM F1160-14 Standard Test Withdrawn and replaced
Method for Shear and Bending with newer version.
Fatigue Testing of Calcium
Phosphate and Metallic Medical
and Composite Calcium Phosphate/
Metallic Coatings.
8-124........................... 8-381 ASTM F2052-14 Standard Test Withdrawn and replaced
Method for Measurement of with newer version.
Magnetically Induced
Displacement Force on Medical
Devices in the Magnetic
Resonance Environment.
8-171........................... ................ ASTM F1609-08 (Reapproved 2014) Reaffirmation.
Standard Specification for
Calcium Phosphate Coatings for
Implantable Materials.
8-198........................... 8-382 ASTM F2102-13 Standard Guide for Withdrawn and replaced
Evaluating the Extent of with newer version.
Oxidation in Polyethylene
Fabricated Forms Intended for
Surgical Implants.
8-207........................... 8-383 ASTM F1926/F1926M-14 Standard Withdrawn and replaced
Test Method for Dissolution with newer version.
Testing of Calcium Phosphate
Granules, Fabricated Forms, and
Coatings.
8-340........................... 8-384 ASTM F2026-14 Standard Withdrawn and replaced
Specification for with newer version.
Polyetheretherketone (PEEK)
Polymers for Surgical Implant
Applications.
8-357........................... 8-385 ASTM F648-14 Standard Withdrawn and replaced
Specification for Ultra-High- with newer version.
Molecular-Weight Polyethylene
Powder and Fabricated Form for
Surgical Implants.
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[[Page 4277]]
I. OB-GYN/Gastroenterology/Urology
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9-6............................. 9-95 IEC 60601-2-36 Edition 2.0 2014- Withdrawn and replaced
04 Medical electrical with newer version.
equipment--Part 2-36:
Particular requirements for the
basic safety and essential
performance of equipment for
extracorporeally induced
lithotripsy.
9-45............................ ................ ASTM F2528-06 (Reapproved 2014) Reaffirmation.
Standard Test Methods for
Enteral Feeding Devices with a
Retention Balloon.
9-62............................ 9-96 IEC 60601-2-2 Edition 5.0 2009- Withdrawn and replaced
02 Medical Electrical with newer version
Equipment--Part 2-2: Particular including technical
Requirements for the Basic corrigendum.
Safety and Essential
Performance of High Frequency
Surgical Equipment and High
Frequency Surgical Accessories
[Including: Technical
Corrigendum 1 (2014)].
9-74............................ 9-97 ISO 13958 Third edition 2014-04- Withdrawn and replaced
01 Concentrates for with newer version.
haemodialysis and related
therapies.
9-76............................ 9-98 ISO 13959 Third edition 2014-04- Withdrawn and replaced
01 Water for haemodialysis and with newer version.
related therapies.
9-77............................ 9-99 ISO 23500 Second edition 2014-04- Withdrawn and replaced
01 Guidance for the preparation with newer version.
and quality management of
fluids for haemodialysis and
related therapies.
9-78............................ 9-100 ISO 11663 Second edition 2014-04- Withdrawn and replaced
01 Quality of dialysis fluid with a newer version.
for haemodialysis and related
therapies.
9-79............................ 9-101 ISO 26722 Second edition 2014-04- Withdrawn and replaced
01 Water treatment equipment with a newer version.
for haemodialysis applications
and related therapies.
9-82............................ 9-102 ISO 4074 Second edition 2014-08- Withdrawn and replaced
15 Natural rubber latex male with newer version.
condoms--Requirements and test
methods.
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J. Ophthalmic
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10-49........................... 10-90 ISO 11979-9 First edition 2006- Withdrawn and replaced
09-01 Ophthalmic implants-- with newer version
Intraocular lenses--Part 9: including amendment.
Multifocal intraocular lenses
[Including: Amendment 1(2014)].
10-50........................... 10-91 ISO 11979-10 First edition 2006- Withdrawn and replaced
08-15 Ophthalmic implants-- with newer version
Intraocular lenses--Part 10: including amendment.
Phakic intraocular lenses
[Including: Amendment 1 (2014)].
10-80........................... ................ ISO 18369-2 Second edition 2012- Extent of recognition and
12-01 Ophthalmic optics-- relevant guidance.
Contact lenses--Part 2:
Tolerances.
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K. Orthopedic
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11-196.......................... 11-281 ASTM F1672-14 Standard Withdrawn and replaced
Specification for Resurfacing newer version.
Patellar Prosthesis.
11-213.......................... 11-282 ASTM F1223-14 Standard Test Withdrawn and replaced
Method for Determination of with newer version.
Total Knee Replacement
Constraint.
11-260.......................... 11-283 ASTM F2943-14 Standard Guide for Withdrawn and replaced
Presentation of End User with newer version.
Labeling Information for
Musculoskeletal Implants.
11-263.......................... 11-284 ASTM F2028-14 Standard Test Withdrawn and replaced
Methods for Dynamic Evaluation with newer version.
of Glenoid Loosening or
Disassociation.
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L. Physical Medicine
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16-189.......................... 16-193 ASME A18.1-2014 Safety Standard Withdrawn and replaced
for Platform Lifts and Stairway with newer version.
Chairlifts.
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M. Radiology
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12-181.......................... 12-284 NEMA NU 1-2012 Performance Withdrawn and replaced
Measurements of Gamma Cameras. with newer version.
12-206.......................... 12-285 IEC 60601-2-1 Edition 3.1 2014- Withdrawn and replaced
07 Medical electrical with newer version.
equipment--Part 2-1: Particular
requirements for the basic
safety and essential
performance of electron
accelerators in the range 1 MeV
to 50 MeV.
12-230.......................... ................ NEMA XR 24-2008 (R2014) Primary Reaffirmation.
User Controls for
Interventional Angiography X-
Ray Equipment.
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N. Sterility
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14-139.......................... ................ ISO 14644-1 First edition 1999- Relevant guidance.
05-01 Cleanrooms and associated
controlled environments--Part
1: Classification of air
cleanliness.
[[Page 4278]]
14-140.......................... ................ ISO 14644-2 First edition 2000- Relevant guidance.
09-15 Cleanrooms and associated
controlled environments--Part
2: Specifications for testing
and monitoring to prove
continued compliance with ISO
14644-1.
14-141.......................... ................ ISO 14644-4 First edition 2001- Relevant guidance.
04-01 Cleanrooms and associated
controlled environments--Part
4: Design, construction and
start-up.
14-165.......................... ................ ISO 14644-5 First edition 2004- Relevant guidance.
08-15 Cleanrooms and associated
controlled environments--Part
5: Operations.
14-166.......................... ................ ISO 14644-7 First edition 2004- Relevant guidance.
10-01 Cleanrooms and associated
controlled environments--Part
7: Separative devices (clean
air hoods, gloveboxes,
isolators and mini-
environments).
14-193.......................... ................ ANSI/AAMI/ISO 11607-1:2006/ Relevant guidance.
(R)2010, Packaging for
terminally sterilized medical
devices--Part 1: Requirements
for materials, sterile barrier
systems, and packaging systems.
14-194.......................... ................ ANSI/AAMI/ISO 11607-2:2006/ Relevant guidance.
(R)2010, Packaging for
terminally sterilized medical
devices--Part 2: Validation
requirements for forming,
sealing and assembly processes.
14-238.......................... ................ AAMI/ANSI/ISO 11140-5:2007/ Relevant guidance.
(R)2012, Sterilization of
health care products--Chemical
indicators--Part 5: Class 2
indicators for Bowie and Dick
air removal test sheets and
packs.
14-242.......................... ................ ISO 14644-3 First edition 2005- Relevant guidance.
12-15 Cleanrooms and associated
controlled environments--Part
3: Test methods.
14-243.......................... ................ ISO 14644-6 First edition Relevant guidance.
Cleanrooms and associated
controlled environments--Part
6: Vocabulary.
14-274.......................... ................ ANSI/AAMI/ISO 15882:2008/ Reaffirmation.
(R)2013, Sterilization of
health care products--Chemical
indicators--Guidance for
selection, use and
interpretation of results.
14-299.......................... 14-453 ASTM F2097-14 Standard Guide for Withdrawn and replaced
Design and Evaluation of with newer version.
Primary Flexible Packaging for
Medical Products.
14-355.......................... 14-454 ISO 11607-1 First edition 2006- Withdrawn and replaced
04-15 Packaging for terminally with newer version
sterilized medical devices-- including amendment.
Part 1: Requirements for
materials, sterile barrier
systems and packaging systems
[Including: Amendment 1 (2014)].
14-356.......................... 14-455 ISO 11607-2 First edition 2006- Withdrawn and replaced
04-15 Packaging for terminally with newer version
sterilized medical devices-- including amendment.
Part 2: Validation requirements
for forming, sealing and
assembly processes [Including:
Amendment 1 (2014)].
14-379.......................... ................ ISO 14644-8 Second edition 2013- Relevant guidance.
02-15 Cleanrooms and associated
controlled environments--Part
8: Classification of air
cleanliness by chemical
concentration (ACC).
14-389.......................... ................ ISO 14644-9 First edition 2012- Relevant guidance.
08-15 Cleanrooms and associated
controlled environments--Part
9: Classification of surface
cleanliness by particle
concentration.
14-390.......................... ................ ISO 14644-10 First edition 2013- Relevant guidance.
03-01 Cleanrooms and associated
controlled environments--Part
10: Classification of surface
cleanliness by chemical
concentration.
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\1\ All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 038.
Table 2--New Entries to the List of Recognized Standards
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Recognition No. Title of standard \1\ Reference No. and date
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A. Anesthesia
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1-102.................. Medical electrical ISO 80601-2-69 First
equipment--Part 2-69: edition 2014-07-15.
Particular
requirements for basic
safety and essential
performance of oxygen
concentrator equipment.
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B. Cardiovascular
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3-133.................. International Standard- ISO 5840-3 First
Cardiovascular edition 2013-03-01.
implants--Cardiac
valve prostheses--Part
3: Heart valve
substitutes implanted
by transcatheter
techniques.
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[[Page 4279]]
C. Dental/Ear, Nose, and Throat
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4-218.................. International Standard- ISO 27020 First
Dentistry--Brackets edition 2010-12-15.
and tubes for use in
orthodontics.
4-219.................. International Standard- ISO 29022 First
Dentistry-Adhesive-Not edition 2013-06-01.
ched Edge Sheer Bond
Strength Test.
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D. General Hospital/General Plastic Surgery
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6-338.................. Standard Specification ASTM D7866-14a.
for Radiation
Attenuating Protective
Gloves.
6-339.................. Standard Consumer ASTM F1169-13.
Safety Specification
for Full-Size Baby
Cribs.
6-340.................. Standard Consumer ASTM F2710-13.
Safety Performance
Specification for
Commercial Cribs.
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E. Nanotechnology
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18-3................... Technical ISO/TS 14101 First
Specification--Surface edition 2012-11-01.
characterization of
gold nanoparticles for
nanomaterial specific
toxicity screening: FT-
IR method.
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F. Neurology
------------------------------------------------------------------------
17-13.................. IEEE Recommended IEEE Std 2010-2012.
Practice for
Neurofeedback Systems.
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G. Ophthalmics
------------------------------------------------------------------------
10-92.................. American National ANSI Z80.20-2010
Standard for (Revision of ANSI
Ophthalmics-Contact Z80.20-2004) 12/06/
Lenses--Standard 2010.
Terminology,
Tolerances,
Measurements and
Physicochemical
Properties.
10-93.................. American National ANSI Z80.27-2014
Standard for (revision of ANSI
Ophthalmics- Z80.27-2001 (R2011))
Implantable Glaucoma 01/27/2014.
Devices.
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H. Orthopedic
------------------------------------------------------------------------
11-285................. Guide to Optimize Scan ASTM F2978-13.
Sequences for Clinical
Diagnostic Evaluation
of Metal-on-Metal Hip
Arthroplasty Devices
using Magnetic
Resonance Imaging.
11-286................. Guide For the ASTM F2979-14.
Characterization of
Wear from the
Articulating Surfaces
in Retrieved Metal-on-
Metal and other Hard-
on-Hard Prostheses.
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I. Radiology
------------------------------------------------------------------------
12-286................. X-ray Equipment for NEMA XR-27-2013 with
Interventional Amendment 1.
Procedures--User
Quality Control Mode.
12-287................. Supplemental NEMA XR 28-2013.
Requirements for User
Information and System
Function Related to
Dose in CT.
12-288................. Characterization of NEMA MS 9-2008.
Phased Array Coils for
Diagnostic Magnetic
Resonance Images (MRI).
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J. Software/Informatics
------------------------------------------------------------------------
13-70.................. Application of risk IEC TR 80001-2-5 2014.
management for IT-
networks incorporating
medical devices--Part
2-5: Application
guidance--Guidance on
distributed alarm
systems.
13-71.................. Logical Observation LOINC 2.48 2014-06-27.
Identifiers Names and
Codes (LOINC).
13-72.................. Health informatics-- IEEE Std 11073-10425-
Personal health device 2014.
communication, Part
10425: Device
Specialization--Contin
uous Glucose Monitor
(CGM).
------------------------------------------------------------------------
K. Sterility
------------------------------------------------------------------------
14-456................. Packaging for ISO/TS 16775 First
terminally sterilized edition 2014-05-15.
medical devices--
Guidance on the
application of ISO
11607-1 and ISO 11607-
2.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
[[Page 4280]]
IV. List of Recognized Standards
FDA maintains the Agency's current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and revisions described in this notice into the database and, upon
publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with Recognition List 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation to
[email protected]. To be properly considered, such recommendations
should contain, at a minimum, the following information: (1) Title of
the standard, (2) any reference number and date, (3) name and address
of the national or international standards development organization,
(4) a proposed list of devices for which a declaration of conformity to
this standard should routinely apply, and (5) a brief identification of
the testing or performance or other characteristics of the device(s)
that would be addressed by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. The Center for Devices and
Radiological Health (CDRH) maintains a site on the Internet for easy
access to information including text, graphics, and files that you may
download to a personal computer with access to the Internet. Updated on
a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices,
includes a link to standards-related documents including the guidance
and the current list of recognized standards. After publication in the
Federal Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 038'' will be available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition
and Use of Consensus Standards,'' and the searchable database for ``FDA
Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
VII. Submission of Comments and Effective Date
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. FDA will consider any comments received in
determining whether to amend the current listing of modifications to
the list of recognized standards, Recognition List Number: 038. These
modifications to the list of recognized standards are effective upon
publication of this notice in the Federal Register.
Dated: January 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01420 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P