[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Pages 52142-52153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18021]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0226]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 018
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: 018'' (Recognition List Number: 018), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit written or electronic 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: Submit written requests for single copies of ``Modifications
to the List of Recognized Standards, Recognition List Number: 018'' to
the Division of Small Manufacturers,
[[Page 52143]]
International and Consumer Assistance, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your requests, or FAX your
request to 301-443-8818. Submit written comments concerning this
document, or recommendations for additional standards for recognition,
to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit
electronic comments by e-mail: [email protected]. This
document may also be accessed on FDA's Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. 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: 018 modifications and other
standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0533.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the 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, are identified in table 1 of this
document.
Table 1.
------------------------------------------------------------------------
Federal Register Cite
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October 16, 1998 (63 FR 55617)
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July 12, 1999 (64 FR 37546)
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November 15, 2000 (65 FR 69022)
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May 7, 2001 (66 FR 23032)
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January 14, 2002 (67 FR 1774)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893)
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April 28, 2003 (68 FR 22391)
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March 8, 2004 (69 FR 10712)
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June 18, 2004 (69 FR 34176)
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October 4, 2004 (69 FR 59240)
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May 27, 2005 (70 FR 30756)
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November 8, 2005 (70 FR 67713)
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March 31, 2006 (71 FR 16313)
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June 23, 2006 (71 FR 36121)
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November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
May 21, 2007 (72 FR 28500)
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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 of this document 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: 018
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the agency will recognize for
use in satisfying premarket reviews 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: 018'' to identify these current
modifications.
In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others; (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 of this document, FDA lists modifications the agency
is making that involve the initial addition of standards not previously
recognized by FDA.
Table 2.
------------------------------------------------------------------------
Old
Item Standard Change Replacement
No. Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
3 ASTM F1161-88, Standard Withdrawn ............
Specification for Minimum
Performance and Safety
Requirements for Components and
Systems of Anesthesia Gas
Machines
------------------------------------------------------------------------
15 ISO 5361-4:1987, Tracheal Tubes-- Contact ............
Part 4: Cole Type person
------------------------------------------------------------------------
35 ISO 5361:1999, Anaesthetic and Contact ............
Respiratory Equipment--Tracheal person
Tubes and Connectors
------------------------------------------------------------------------
36 ISO 5366-3:2001, Anaesthetic and Contact ............
Respiratory Equipment-- person
Tracheostomy Tubes--Part 3:
Pediatric Tracheostomy Tubes
------------------------------------------------------------------------
42 ISO 5360:2006, Anaesthetic Withdrawn and 74
Vaporizers--Agent Specific replaced
Filling Systems with newer
version
------------------------------------------------------------------------
[[Page 52144]]
43 ISO 5362:2006, Anaesthetic Withdrawn and 75
Reservoir Bags replaced
with newer
version
------------------------------------------------------------------------
44 ISO 5366-1:2000, Anaesthetic and Contact ............
Respiratory Equipment-- person
Tracheostomy Tubes--Part 1: Tubes
and Connectors for Use in Adults
------------------------------------------------------------------------
46 ISO 5367:2000, Breathing Tubes Contact ............
Intended for Use With Anaesthetic person
Apparatus and Ventilators
------------------------------------------------------------------------
50 ASTM F920-93(1999): Standard Withdrawn ............
Specification for Minimum
Performance and Safety
Requirements for Resuscitators
Intended for Use with Humans
------------------------------------------------------------------------
55 ASTM F1054-01: Standard Withdrawn ............
Specification for Conical
Fittings
------------------------------------------------------------------------
61 IEC 60601-2-13(2003-05), Medical Contact ............
Electrical Equipment--Part 2-13: person
Particular Requirements for the
Safety and Essential Performance
of Anaesthetic Systems
------------------------------------------------------------------------
62 ISO 5356-1:2004, Anaesthetic and Contact ............
Respiratory Equipment--Conical person
Connectors: Part 1: Cones and
Sockets
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
21 AAMI / ANSI / ISO 10993-11:1993, Contact ............
Biological Evaluation of Medical person
Devices--Part 11: Tests for
Systemic Toxicity
------------------------------------------------------------------------
63 AAMI / ANSI / ISO 10993-6:1995/(R) Contact ............
2001, Biological Evaluation of person
Medical Devices--Part 6: Test for
Local Effects After Implantation
------------------------------------------------------------------------
64 AAMI / ANSI / ISO 10993-5:1999, Contact ............
Biological Evaluation of Medical person
Devices--Part 5: Tests for In
Vitro Cytotoxicity
------------------------------------------------------------------------
68 ASTM F719-81(2002)e1: Standard Contact ............
Practice for Testing Biomaterials person
in Rabbits for Primary Skin
Irritation
------------------------------------------------------------------------
70 ASTM F750-87 (2002)e1: Standard Contact ............
Practice for Evaluating Material person
Extracts by Systemic Injection in
the Mouse
------------------------------------------------------------------------
71 ASTM F1408-02e1: Standard Practice Contact ............
for Subcutaneous Screening Test person
for Implant Materials
------------------------------------------------------------------------
83 ASTM E1262-88(2003): Standard Contact ............
Guide for Performance of the person
Chinese Hamster Ovary Cell/
Hypoxanthine Guanine
Phosphoribosyl Transferase Gene
Mutation Assay
------------------------------------------------------------------------
84 ASTM E1263-97(2003): Standard Contact ............
Guide for Conduct of Micronucleus person
Assays in Mammalian Bone Marrow
Erythrocytes
------------------------------------------------------------------------
85 ASTM E1280-97 (2003): Standard Contact ............
Guide for Performing the Mouse person
Lymphoma Assay for Mammalian Cell
Mutagenicity
------------------------------------------------------------------------
87 AAMI / ANSI / ISO 10993-10:2002, Contact ............
Biological Evaluation of Medical person
Devices--Part 10: Tests for
Irritation and Sensitization
------------------------------------------------------------------------
88 AAMI / ANSI / ISO 10993-12: Contact ............
2002(E), Biological Evaluation of person
Medical Devices--Part 12: Sample
Preparation and Reference
materials
------------------------------------------------------------------------
89 ASTM F749-98 (2002)e2: Standard Contact ............
Practice for Evaluating Material person
Extracts by Intracutaneous
Injection in the Rabbit
------------------------------------------------------------------------
90 ASTM E1397-91(2003): Standard Contact ............
Practice for the in vitro Rat person
Hepatocyte DNA Repair Assay
------------------------------------------------------------------------
91 ASTM E1398-91(2003): Standard Contact ............
Practice for the in vivo Rat person
Hepatocyte DNA Repair Assay
------------------------------------------------------------------------
92 ASTM F748-04: Standard Practice Contact ............
for Selecting Generic Biological person
Test Methods for Materials and
Devices
------------------------------------------------------------------------
93 ASTM F763-04: Standard Practice Contact ............
for Short-Term Screening of person
Implant Materials
------------------------------------------------------------------------
[[Page 52145]]
94 ASTM F981-04: Standard Practice Contact ............
for Assessment of Compatibility person
of Biomaterials for Surgical
Implants with Respect to Effect
of Materials on Muscle and Bone
------------------------------------------------------------------------
97 ASTM F1983-99(2003): Standard Contact ............
Practice for Assessment of person
Compatibility of Absorbable/
Resorbable Biomaterials for
Implant Applications
------------------------------------------------------------------------
98 AAMI / ANSI / ISO 10993-1:2003(E), Contact ............
Biological evaluation of medical person
devices--Part 1: Evaluation and
Testing
------------------------------------------------------------------------
99 ASTM F1904-98(2003): Standard Contact ............
Practice for Testing the person
Biological Responses to Particles
In Vivo
------------------------------------------------------------------------
100 ASTM E1372-95(2003): Standard Test Contact ............
Method for Conducting a 90-Day person
Oral Toxicity Study in Rats
------------------------------------------------------------------------
106 ASTM F619-03: Standard Practice Contact ............
for Extraction of Medical person
Plastics
------------------------------------------------------------------------
109 USP 29-NF21 Biological Tests <87>, Contact ............
Biological Reactivity Test, In person
Vitro--Direct Contact Test
------------------------------------------------------------------------
110 USP 29-NF21 Biological Tests <87>, Contact ............
Biological Reactivity Test, In person
Vitro--Elution Test
------------------------------------------------------------------------
111 USP 29-NF21 Biological Tests <88>, Contact ............
Biological Reactivity Tests, In person
Vivo, Procedure--Preparation of
Sample
------------------------------------------------------------------------
112 USP 29-NF21 Biological Tests <88>, Contact ............
Biological Reactivity Test, In person
Vitro, Classification of
Plastics--Intracutaneous Test
------------------------------------------------------------------------
113 USP 29-NF21 Biological Tests <88>, Contact ............
Biological Reactivity Tests, In person
Vivo, Classification of Plastics--
Systemic Injection Test
------------------------------------------------------------------------
114 ASTM F1877-05: Standard Practice Contact ............
for Characterization of Particles person
------------------------------------------------------------------------
115 ASTM F895-84(2006): Standard Test Contact ............
Method for Agar Diffusion cell person
Culture Screening for
Cytotoxicity
------------------------------------------------------------------------
116 ASTM F1439-03: Standard Guide for Contact ............
Performance of Lifetime Bioassay person
for the Tumorigenic Potential of
Implant Materials
------------------------------------------------------------------------
C. General
------------------------------------------------------------------------
2 IEC 60601-1, Medical electrical Withdrawn ............
equipment -- Part 1: General
requirements for safety
------------------------------------------------------------------------
11 ISO 2859-1:1999: Sampling Withdrawn and 37
Procedures for Inspection By replaced
Attributes--Part 1: Sampling with newer
Schemes Indexed by Acceptance year version
Quality Limit (AQL)for Lot-by-Lot
Inspection
------------------------------------------------------------------------
14 ANSI/ASQ Z1.4-2003: Sampling Withdrawn and 38
Procedures and Tables for replaced
Inspection by Attributes with newer
year version
------------------------------------------------------------------------
22 ISO 2768-1: 1989, General Contact name ............
Tolerances--Part 1: Tolerances
for Linear and Angular Dimensions
Without Individual Tolerance
Indications
------------------------------------------------------------------------
23 ISO 2768-2: 1989, General Contact name ............
Tolerances--Part 2: Geometrical
Tolerances for Features Without
Individual Tolerance Indications
------------------------------------------------------------------------
24 IEC 60812, edition 2.0: 2006-01, Withdrawn and 39
Analysis Technique for System replaced
Reliability--Procedure for with newer
Failure Mode and Effects Analysis year version
------------------------------------------------------------------------
26 ISO 14971:2007: Medical devices-- Withdrawn and 40
Application of Risk Management to replaced
Medical Devices with newer
year version
------------------------------------------------------------------------
28 IEC 60601-1-2, (Second Edition, Extent of ............
2001), Medical Electrical recognition
Equipment--Part 1-2: General
Requirements for Safety;
Electromagnetic Compatibility--
Requirements and Tests
------------------------------------------------------------------------
[[Page 52146]]
30 AAMI/ANSI/IEC 60601-1-2, Medical Title change ............
Electrical Equipment--Part 1-2: Type of
General Requirements for Safety-- standard
Collateral Standard: Extent of
Electromagnetic Compatibility-- recognition
Requirements and Tests. (The AAMI/
ANSI/IEC 60601-1-2:2001 is the
U.S. version of IEC 60601-1-
2:2001 with identical
requirements for electromagnetic
compatibility (EMC) of medical
electrical equipment.)
------------------------------------------------------------------------
34 IEC 60601-1-2, Medical Electrical Extent of ............
Equipment--Part 1-2: General recognition
Requirements for Safety--
Collateral Standard:
Electromagnetic Compatibility--
Requirements and Tests (Edition
2:2001 with Amendment 1:2004;
Edition 2.1 (Edition 2:2001
consolidated with Amendment
1:2004))
------------------------------------------------------------------------
35 AAMI/ANSI/IEC 60601-1-2, Medical Extent of ............
Electrical Equipment--Part 1-2: recognition
General Requirements for Safety--
Collateral Standard:
Electromagnetic Compatibility--
Requirements and Tests (Edition
2:2001 with Amendment 1:2004)
(AAMI/ANSI/IEC 60601-1-2:2001 is
the U.S. version of IEC 60601-1-
2:2001, with identical
requirements for electromagnetic
compatibility (EMC) of medical
electrical equipment.)
------------------------------------------------------------------------
D. General Hospital/ General Plastic Surgery
------------------------------------------------------------------------
18 ISO 8537:1991 Sterile Single-use Withdrawn ............
Syringes, With or Without Needle, duplicate
for Insulin
------------------------------------------------------------------------
20 ISO 10555-1-1995 Sterile, Single- Withdrawn ............
use Intravascular Catheters--Part duplicate
1: General Requirements
------------------------------------------------------------------------
46 IEC 60601-2-2 2006 Medical Withdrawn and 197
Electrical Equipment--Part 2-2: replaced
Particular Requirements for the with newer
Safety of High Frequency Surgical version
Equipment
------------------------------------------------------------------------
69 ISO 9626-1991: Stainless Steel Withdrawn ............
Needle Tubing for the Manufacture duplicate
of Medical Devices
------------------------------------------------------------------------
72 ISO 10555-5 1996-06-15 Sterile, Withdrawn ............
Single-use Intravascular duplicate
Catheters--Part 5: Over-needle
Peripheral Catheters
------------------------------------------------------------------------
96 ASTM F2101-07 Standard Test Method Withdrawn and 199
for Evaluating the Bacterial replaced
Filtration Efficiency (BFE) of with newer
Medical Face Mask Materials, version
Using a Biological Aerosol of
Staphylococcus Aureus
------------------------------------------------------------------------
113 ASTM F2100-07 Standard Withdrawn and 198
Specification for Performance of replaced
Materials Used in Medical Face with newer
Masks version
------------------------------------------------------------------------
108 ASTM F754-00 Standard Transferred ............
Specification for Implantable to materials
Polytetrafluoroethylene (PTFE)
Polymer Fabricated in Sheet, Tube
and Rod Shapes
------------------------------------------------------------------------
109 ASTM F881-94(2006) Standard Withdrawn and 185
Specification for Silicone replaced
Elastomer Facial Implants with newer
version
------------------------------------------------------------------------
128 ASTM F1670-07 Standard Test Method Withdrawn and 186
for Resistance of Materials Used replaced
in Protective Clothing to with newer
Penetration by Synthetic Blood version
------------------------------------------------------------------------
130 ASTM F1671-07 Standard Test Method Withdrawn and 187
for Resistance of Materials Used replaced
in Protective Clothing to with newer
Penetration by Blood-Borne version
Pathogens Using Phi-X174
Bacteriophage Penetration as a
Test System
------------------------------------------------------------------------
151 USP 30:2007 Nonabsorbable Surgical Withdrawn and 188
Suture replaced
with newer
version
------------------------------------------------------------------------
152 USP 30<11>: 2007 Sterile Sodium Withdrawn and 189
Chloride for Irrigation replaced
with newer
version
------------------------------------------------------------------------
153 USP 30:2007 Absorbable Surgical Withdrawn and 190
Suture replaced
with newer
version
------------------------------------------------------------------------
154 USP 30<881>:2007 Tensile Strength Withdrawn and 191
replaced
with newer
version
------------------------------------------------------------------------
155 USP 30<861>:2007 Sutures--Diameter Withdrawn and 192
replaced
with newer
version
------------------------------------------------------------------------
156 USP 30<871>:2007 Sutures Needle Withdrawn and 193
Attachment replaced
with newer
version
------------------------------------------------------------------------
[[Page 52147]]
157 USP 30<11>: 2007 Sterile Water for Withdrawn and 194
Irrigation replaced
with newer
version
------------------------------------------------------------------------
158 USP 30<11>: 2007 Heparin Lock Withdrawn and 195
Flush Solution replaced
with newer
version
------------------------------------------------------------------------
159 USP 30<11>: 2007 Sodium Chloride Withdrawn and 196
Injection replaced
with newer
version
------------------------------------------------------------------------
181 ASTM F1862-07: Standard Test Withdrawn and 184
Method for Resistance of Medical replaced
Face Masks to Penetration by with newer
Synthetic Blood (Horizontal version
Projection of Fixed Volume at a
Known Velocity)
------------------------------------------------------------------------
E. Materials
------------------------------------------------------------------------
2 ASTM F75-07: Standard Withdrawn and 137
Specification for Cobalt-28 replaced
Chromium-6 Molybdenum Alloy with newer
Castings and Casting Alloy for year version
Surgical Implants (UNS R30075)
------------------------------------------------------------------------
15 ASTM F745-07: Standard Withdrawn and 138
Specification for 18 Chromium- replaced
12.5 Nickel-2.5 Molybdenum with newer
Stainless Steel for Cast and year version
Solution-Annealed Surgical
Implant Applications
------------------------------------------------------------------------
26 ASTM F1314-07: Standard Withdrawn and 139
Specification for Wrought replaced
Nitrogen Strengthened 22 with newer
Chromium--13 Nickel--5 Manganese-- year version
2.5 Molybdenum Stainless Steel
Alloy Bar and Wire for Surgical
Implants (UNS S20910)
------------------------------------------------------------------------
37 ASTM F1813-06: Standard Withdrawn and 140
Specification for Wrought replaced
Titanium--12 Molybdenum--6 with newer
Zirconium--2 Iron Alloy for year version
Surgical Implant (UNS R58120)
------------------------------------------------------------------------
43 ASTM F2146-07: Standard Withdrawn and 141
Specification for Wrought replaced
Titanium-3Aluminum-2.5Vanadium with newer
Alloy Seamless Tubing for year version
Surgical Implant Applications
(UNS R56320)
------------------------------------------------------------------------
67 ISO 7153-1:1991/Amd. 1:1999, Contact ............
Surgical Instruments--Metallic person
Materials--Part 1: Stainless
Steel
------------------------------------------------------------------------
87 ASTM F1978-00(2007)e2: Standard Withdrawn and 142
Test Method for Measuring replaced
Abrasion Resistance of Metallic with newer
Thermal Spray Coatings by Using year version
the Taber Abraser
------------------------------------------------------------------------
89 ASTM F1873-98: Standard Withdrawn ............
Specification for High-Purity
Dense Yttria Tetragonal Zirconium
Oxide Polycrystal (Y-TZP) for
Surgical Implant Applications
------------------------------------------------------------------------
106 ASTM F648-07: Standard Withdrawn and 143
Specification for Ultra-High- replaced
Molecular-Weight Polyethylene with newer
Powder and Fabricated Form for year version
Surgical Implants
------------------------------------------------------------------------
128 ASTM F2213-06: Standard Test Title ............
Method for Measurement of
Magnetically Induced Torque on
Medical Devices in the Magnetic
Resonance Environment
------------------------------------------------------------------------
GH/GPS ASTM F754-00: Standard Transferred 144
108 Specification for Implantable from GH/GPS
Polytetrafluoroethylene (PTFE) to Materials
Polymer Fabricated in Sheet,
Tube, and Rod Shapes
------------------------------------------------------------------------
F. OB-GYN/Gastroenterology
------------------------------------------------------------------------
20 ISO 8600-3:1997 Amendment 1 2003, Withdraw ............
Optics and Optical Instruments-- duplicate
Medical Endoscopes and Endoscopic
Accessories Part 3: Determination
of Field of View and Direction of
View of Endoscopes with Optics
------------------------------------------------------------------------
32 ASTM D3492-03 Standard Extent of ............
Specification for Rubber recognition,
Contraceptives (Male Condoms) processes
impacted,
relevant
guidance
------------------------------------------------------------------------
33 ASTM F623-99(2006) Standard Withdrawn and 44
Performance Specification for replaced
Foley Catheter with newer
version
------------------------------------------------------------------------
34 ISO 4074:2002/Cor.1:2003(E) Extent of ............
Natural Latex Rubber Condoms-- recognition,
Requirements and Test Methods, relevant
Technical Corrigendum 1 guidance
------------------------------------------------------------------------
G. Ophthalmic
------------------------------------------------------------------------
1 ISO 9338:1996 Optics and Optical Withdrawn ............
Instruments--Contact Lenses--
Determination of the Diameters
------------------------------------------------------------------------
[[Page 52148]]
2 ISO 9339-1:1996 Optics and Optical Withdrawn ............
Instruments--Contact Lenses--
Determination of the Thickness--
Part 1: Rigid Contact Lenses
------------------------------------------------------------------------
4 ISO 9341:1996 Optics and Optical Withdrawn ............
Instruments--Contact Lenses--
Determination of Inclusions and
Surface Imperfections for Rigid
Contact Lenses
------------------------------------------------------------------------
7 ISO 9913-1:1996 Optics and Optical Withdrawn ............
Instruments--Contact Lenses--Part
1: Determination of Oxygen
Permeability and Transmissibility
with the FATT Method
------------------------------------------------------------------------
8 ISO 10338:1996 Optics and Optical Withdrawn ............
Instruments--Contact Lenses--
Determination of Curvature
------------------------------------------------------------------------
9 ISO 10339:1997 Ophthalmic Optics-- Withdrawn ............
Contact Lenses--Determination of
Water Content of Hydrogel Lenses
------------------------------------------------------------------------
10 ISO 10340:1995 Optics and Optical Withdrawn ............
Instruments--Contact Lenses--
Method for Determining the
Extractable Substances
------------------------------------------------------------------------
11 ISO 10344:1996 Optics and Optical Withdrawn ............
Instruments--Contact Lenses--
Saline Solution for Contact Lens
Testing
------------------------------------------------------------------------
16 ISO 9913-2:2000 Optics and Optical Withdrawn ............
Instruments--Contact Lenses--Part
2: Determination of Oxygen
Permeability and Transmissibility
by the Coulometric Method
------------------------------------------------------------------------
17 ISO 10939:2007 Ophthalmic Withdrawn and 35
Instruments--Slit-lamp replaced
Microscopes with newer
version
------------------------------------------------------------------------
19 ISO 11539:1999 Ophthalmic Optics-- Withdrawn ............
Contact Lenses--Classification of
Contact Lenses and Contact Lens
Materials
------------------------------------------------------------------------
22 ISO 11979-3:2006 Ophthalmic Withdrawn and 36
Implants--Intraocular Lenses-- replaced
Part 3: Mechanical Properties and with newer
Test Methods version
------------------------------------------------------------------------
25 ISO 12865:2006 Ophthalmic Withdrawn and 39
Instruments--Retinoscopes replaced
with newer
version
------------------------------------------------------------------------
27 ISO 11979-7:2006 Ophthalmic Withdrawn and 41
Implants--Intraocular Lenses-- replaced
Part 7: Clinical Investigations with newer
version
------------------------------------------------------------------------
H. Orthopedic/ Physical Medicine
------------------------------------------------------------------------
121 ISO 7207-1:1994, Implants for Withdrawn ............
Surgery--Components for Partial
and Total Knee Joint Prostheses--
Part 1: Classification,
Definitions and Designation of
Dimensions
------------------------------------------------------------------------
I. Radiology
------------------------------------------------------------------------
57 & IEC 60731 (1997), (2002) Amendment Withdrawn and 162
132 1, Medical Electrical Equipment-- combine
Dosimeters with Ionization
Chambers as Used in Radiotherapy
------------------------------------------------------------------------
59 IEC 61168:1993, Radiotherapy Contact ............
Simulators--Functional person
Performance Characteristics
------------------------------------------------------------------------
63 IEC 60601-2-43--Ed. 1.0, Medical Contact ............
Electrical Equipment--Part 2-43: person
Particular Requirements for the
Safety of X-ray Equipment for
Interventional Procedures
------------------------------------------------------------------------
91 IEC 60601-2-8 (1997-08), Amendment Withdrawn ............
1--Medical Electrical Equipment-- duplicate
Part 2: Particular Requirements
for the Safety of Therapeutic X-
ray Equipment Operating in the
Range of 10 kV to 1 MV
------------------------------------------------------------------------
103 ANSI / IESNA RP-27.3-1996, Title ............
Recommended Practice for
Photobiological Safety for Lamps--
Risk Group Classification and
Labeling
------------------------------------------------------------------------
130 & IEC 60601-2-37 (2004), (2005) Withdrawn and 164
148 Amendment 2, Medical Electrical combine
Equipment--Part 2-37: Particular
Requirements for the Safety of
Ultrasonic Medical Diagnostic and
Monitoring Equipment
------------------------------------------------------------------------
131 IEC 61217 2002:, Radiotherapy Contact ............
Equipment--Coordinates, person
Movements, and Scales
Consolidated Ed. 1.1
------------------------------------------------------------------------
[[Page 52149]]
133 IEC 60601-2-11 (1997), (2004) Title ............
Amendment 1, Medical Electrical
Equipment--Part 2-11: Particular
Requirements for the Safety of
gamma Beam Therapy Equipment
------------------------------------------------------------------------
145 IEC 61674 (1997), (2002) Amendment Contact ............
1, Medical Electrical Equipment-- person
Dosimeters with Ionization
Chambers and/or Semi-conductor
Detectors as Used in X-ray
Diagnostic Imaging
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
28 ANSI/AAMI/ISO 11737-1:2006, Withdrawn and 227
Sterilization of Medical Devices-- replaced
Microbiological Methods--Part 1: with newer
Determination of a Population of version
Microorganisms on Products, 2nd
ed.
------------------------------------------------------------------------
47 ANSI/AAMI ST37:1996, Flash Withdrawn ............
Sterilization: Steam
Sterilization of Patient Care
Items for Immediate Use
------------------------------------------------------------------------
49 ANSI/AAMI ST41:1999/(R) 2005, Reaffirmation ............
Ethylene Oxide Sterilization in
Health Care Facilities: Safety
and Effectiveness
------------------------------------------------------------------------
50 ANSI/AAMI ST42:1998, Steam Withdrawn ............
Sterilization and Sterility
Assurance Using Table-top
Sterilizers in Office-based,
Ambulatory-care Medical,
Surgical, and Dental Facilities.
------------------------------------------------------------------------
52 ANSI/AAMI ST59:1999, Sterilization Withdrawn ............
of Health Care Products--
Biological Indicators--Part 1:
General
------------------------------------------------------------------------
53 ANSI/AAMI ST66:1996, Sterilization Contact ............
of Health Care Products--Chemical person
Indicators--Part 2: Indicators
for Air Removal Test Sheets and
Packs
------------------------------------------------------------------------
54 ANSI/AAMI/ISO 11737-2:1998, Contact ............
Sterilization of Medical Devices-- person
Microbiological Methods--Part 2:
Tests of Sterility Performed in
the Validation of a Sterilization
Process
------------------------------------------------------------------------
60 ASTM F1327:1998, Standard Contact ............
Terminology Relating to Barrier person
Materials for Medical Packaging
------------------------------------------------------------------------
63 ASTM F1886: 1998 (2004), Standard Contact ............
Test Method for Determining person
Integrity of Seals for Medical
Packaging by Visual Inspection
------------------------------------------------------------------------
64 ASTM F1929:1998 (2004), Standard Contact ............
Test Method for Detecting Seal person
Leaks in Porous Medical Packaging
by Dye Penetration
------------------------------------------------------------------------
72 ANSI/AAMI ST33:1996, Guidelines Withdrawn ............
for the Selection and Use of
Reusable Rigid Sterilization
Container Systems for Ethylene
Oxide Sterilization and Steam
Sterilization in Health Care
Facilities
------------------------------------------------------------------------
75 ANSI/AAMI/ISO 11137:1994, Withdrawn ............
Sterilization of Health Care
Products--Requirements for
Validation and Routine Control--
Radiation Sterilization and ANSI/
AAMI/ISO 11137:1994 (Amendment
1:2002)
------------------------------------------------------------------------
77 ANSI/AAMI ST24:1999/(R) 2005, Reaffirmation ............
Automatic, General Purpose
Ethylene Oxide Sterilizers and
Ethylene Oxide Sterilant Sources
Intended for use in Health Care
Facilities, 3rd ed.
------------------------------------------------------------------------
86 ASTM F1980:2002, Standard Guide Contact ............
for Accelerated Aging of Sterile person
Medical Device Packages
------------------------------------------------------------------------
88 ANSI/AAMI/ISO 14937:2000, Extent of ............
Sterilization of Health Care recognition
Products--General Requirements
for Characterization of a
Sterilizing Agent and the
Development, Validation, and
Routine Control of a
Sterilization Process for Medical
Devices
------------------------------------------------------------------------
90 ASTM F2095-01, Standard Test Contact ............
Methods for Pressure Decay Leak person
Test for Nonporous Flexible
Packages With and Without
Restraining Plates
------------------------------------------------------------------------
105 ANSI/AAMI ST46:2002, Steam Withdrawn ............
Sterilization and Sterility
Assurance in Health Care
Facilities
------------------------------------------------------------------------
116 ANSI/AAMI ST72:2002, Bacterial Contact ............
Endotoxins--Test Methodologies, person
Routine Monitoring, and
Alternatives to Batch Testing
------------------------------------------------------------------------
[[Page 52150]]
117 ANSI/AAMI ST35:2003, Safe Handling Extent of ............
and Biological Decontamination of recognition
Reusable Medical Devices in
Health Care Facilities and in
Nonclinical Settings
------------------------------------------------------------------------
120 ASTM D3078:2002, Standard Test Contact ............
Method for Determination of Leaks person
in Flexible Packaging by Bubble
Emission
------------------------------------------------------------------------
123 ASTM F2096-04, Standard Test Contact ............
Method for Detecting Gross Leaks person
in Medical Packaging by Internal
Pressurization (Bubble Test)
------------------------------------------------------------------------
134 ANSI/AAMI ST44:2002, Resistometers Withdrawn ............
Used for Characterizing the
Performance of Biological and
Chemical Indicators
------------------------------------------------------------------------
135 ANSI/AAMI ST63:2002, Sterilization Extent of ............
of Health Care Products-- recognition
Requirements for the Development,
Validation and Routine Control of
an Industrial Sterilization
Process for Medical Devices--Dry
heat
------------------------------------------------------------------------
136 ANSI/AAMI ST67:2003, Sterilization Contact ............
of Health Care Products-- person
Requirements for Products Labeled
`sterile'
------------------------------------------------------------------------
137 ANSI/AAMI/ISO TIR 11139:2006, Withdrawn and 221
Sterilization of Health Care replaced
Products--Vocabulary with newer
version
------------------------------------------------------------------------
144 ASTM F2203-02e1, Standard Test Contact ............
Method for Linear Measurement person
Using Precision Steel Rule
------------------------------------------------------------------------
145 ASTM F2217-02, Standard Practice Contact ............
for Coating/Adhesive Weight person
Determination
------------------------------------------------------------------------
146 ASTM F2227-02, Standard Test Contact ............
Method of Leaks in Non-sealed and person
Empty Medical Packaging Trays by
C02 Tracer Gas Method
------------------------------------------------------------------------
147 ASTM F2228-02, Standard Test Contact ............
Method for Non-Destructive person
Detection of Leaks in Medical
Packaging Which Incorporates
Porous Barrier Material by C02
Tracer Gas Method
------------------------------------------------------------------------
148 ASTM F2250-03, Standard Practice Contact ............
for Evaluation of Chemical person
Resistance of Printed Inks and
Coatings on Flexible Packaging
Materials
------------------------------------------------------------------------
149 ASTM F2251-03e1, Standard Test Contact ............
Method for Thickness Measurement person
of Flexible Packaging Material
------------------------------------------------------------------------
150 ASTM F2252-03, Standard Practice Contact ............
for Evaluating Ink or Coating person
Adhesion to Flexible Packaging
Materials Using Tape
------------------------------------------------------------------------
163 ANSI/AAMI/ISO 11737-3:2004, Withdrawn ............
Sterilization of Medical Devices--
Microbiological Methods--Part 3:
Guidance on Evaluation and
Interpretation of Bioburden Data
------------------------------------------------------------------------
167 ASTM F2097-05, Standard Guide for Contact ............
Design and Evaluation of Primary person
Packaging for Medical Products
------------------------------------------------------------------------
168 ASTM F2338-05, Standard Test Contact ............
Method for Nondestructive person
Detection of Leaks in Packages by
Vacuum Decay Method
------------------------------------------------------------------------
169 ASTM F2391-05, Standard Test Contact ............
Method for Measuring Package and person
Seal Integrity Using Helium as
Tracer Gas
------------------------------------------------------------------------
170 ASTM F2475-05, Standard Guide for Contact ............
Biocompatibility Evaluation of person
Medical Device Packaging
Materials
------------------------------------------------------------------------
171 ANSI/AAMI/ISO 15882:2003, Chemical Contact ............
Indicators--Guidance on the person
Selection, Use, and
Interpretation of Results
------------------------------------------------------------------------
172 AOAC 6.2.01:2006, Official Method Withdrawn and 211
955.14, Testing Disinfectants replaced
Against Salmonella choleraesuis, with newer
Use-Dilution Method version
------------------------------------------------------------------------
173 AOAC 6.2.02:2006, Official Method Withdrawn and 212
991.47, Testing Disinfectants replaced
Against Salmonella choleraesuis, with newer
Hard Surface Carrier Test Method version
------------------------------------------------------------------------
174 AOAC 6.2.03:2006, Official Method Withdrawn and 213
991.48, Testing Disinfectants replaced
Against Staphylococcus aureus, with newer
Hard Surface Carrier Test Method version
------------------------------------------------------------------------
[[Page 52151]]
175 AOAC 6.2.04:2006, Official Method Withdrawn and 214
955.15, Testing Disinfectants replaced
Against Staphylococcus aureus, with newer
Use-Dilution Method version
------------------------------------------------------------------------
176 AOAC 6.2.05:2006, Official Method Withdrawn and 215
991.49, Testing Disinfectants replaced
Against Pseudomonas aeruginosa, with newer
Hard Surface Carrier Test Method version
------------------------------------------------------------------------
177 AOAC 6.2.06:2006, Official Method Withdrawn and 216
964.02, Testing Disinfectants replaced
Against Pseudomonas aeruginosa, with newer
Use-Dilution Method version
------------------------------------------------------------------------
178 AOAC 6.3.02:2006, Official Method Withdrawn and 217
955.17, Fungicidal Activity of replaced
Disinfectants Using Trichophyton with newer
mentagrophytes version
------------------------------------------------------------------------
179 AOAC 6.3.05:2006, Official Method Withdrawn and 218
966.04, Sporicidal Activity of replaced
Disinfectants, Method I with newer
version
------------------------------------------------------------------------
180 AOAC 6.3.06:2006, Official Method Withdrawn and 219
965.12, Tuberculocidal Activity replaced
of Disinfectants with newer
version
------------------------------------------------------------------------
181 ANSI/AAMI ST58:2005, Chemical Title, ............
Sterilization and High-Level Devices
Disinfection in Health Care affected and
Facilities Relevant
guidance
------------------------------------------------------------------------
182 USP 30:2007, Biological Indicator Withdrawn and 202
for Dry-Heat Sterilization, Paper replaced
Carrier with newer
version
------------------------------------------------------------------------
183 USP 30:2007, Biological Indicator Withdrawn and 203
for Ethylene Oxide Sterilization, replaced
Paper Carrier with newer
version
------------------------------------------------------------------------
184 USP 30:2007, Biological Indicator Withdrawn and 204
for Steam Sterilization, Paper replaced
Carrier with newer
version
------------------------------------------------------------------------
185 USP 30:2007, <61> Microbial Limits Withdrawn and 205
Test replaced
with newer
version
------------------------------------------------------------------------
186 USP 30:2007, <71> Microbiological Withdrawn and 206
Tests, Sterility Tests replaced
with newer
version
------------------------------------------------------------------------
187 USP 30:2007, <85> Biological Tests Withdrawn and 207
and Assays, Bacterial Endotoxin replaced
Test (LAL) with newer
version
------------------------------------------------------------------------
188 USP 30:2007, <151> Pyrogen Test Withdrawn and 208
(USP Rabbit Test) replaced
with newer
version
------------------------------------------------------------------------
189 USP 30:2007, <161> Transfusion and Withdrawn and 209
Infusion Assemblies and Similar replaced
Medical Devices with newer
version
------------------------------------------------------------------------
190 USP 30:2007, Biological Indicator Withdrawn and 210
for Steam Sterilization, Self- replaced
Contained with newer
version
------------------------------------------------------------------------
193 ANSI/AAMI/ISO 11607-1:2006, Contact ............
Packaging for Terminally person
Sterilized Medical Devices--Part
1: Requirements for Materials,
Sterile Barrier Systems and
Packaging Systems, 3rd ed.
------------------------------------------------------------------------
194 ANSI/AAMI/ISO 11607-2:2006, Contact ............
Packaging for Terminally person
Sterilized Medical Devices--Part
2: Validation Requirements for
Forming, Sealing and Assembly
Processes, 1st ed.
------------------------------------------------------------------------
196 ASTM F1140-2005, Standard Test Contact ............
Methods for Internal person
Pressurization Failure Resistance
of Unrestrained Packages for
Medical Applications
------------------------------------------------------------------------
197 ASTM F1608:2004, Standard Test Contact ............
Method for Microbial Ranking of person
Porous Packaging Materials
(Exposure Chamber Method)
------------------------------------------------------------------------
198 ASTM F2054-05, Standard Test Contact ............
Method for Burst Testing of person
Flexible Package Seals Using
Internal Air Pressurization
Within Restraining Plates
------------------------------------------------------------------------
199 ASTM D4169-05, Standard Practice Contact ............
for Performance Testing of person
Shipping Containers and Systems
------------------------------------------------------------------------
200 ASTM F88-2005, Standard Test Contact ............
Method for Seal Strength of person
Flexible Barrier Materials
------------------------------------------------------------------------
[[Page 52152]]
K. Tissue Engineering
------------------------------------------------------------------------
3 ASTM F2212-02(2007)e1, Standard Withdrawn and 11
Guide for Characterization of replaced
Type I Collagen as Starting with newer
Material for Surgical Implants version
and Substrates for Tissue
Engineered Medical Products
(TEMPs)
------------------------------------------------------------------------
III. Listing of New Entries
In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 018.
Table 3.
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
72 Lung Ventilators for Medical Use-- ISO 10651-5:2006
Particular Requirements for Basic
Safety and Essential Performance--Part
5: Gas-powered Emergency Resuscitators
------------------------------------------------------------------------
73 Lung Ventilators--Part 4: Particular ISO 10651-4:2002
Requirements for Operator Powered
Resuscitators
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
117 Biological Evaluation of Medical ANSI/AAMI/ISO 10993-
Devices--Part 3: Tests for 3: 2003
Genotoxicity, Carcinogenicity, and
Reproductive Toxicity
------------------------------------------------------------------------
C. Dental/ ENT
------------------------------------------------------------------------
144 Dentistry-Mercury and Alloys for Dental ISO 24234: 2004(E)
Amalgam
------------------------------------------------------------------------
D. OB-GYN/Gastroenterology
------------------------------------------------------------------------
45 Standard Test Methods for Enteral ASTM F2528-06
Feeding Devices with a Retention
Balloon
------------------------------------------------------------------------
E. Ophthalmic
------------------------------------------------------------------------
42 Ophthalmic Implants--Intraocular ISO 11979-2:1999/
lenses--Part 2: Optical Properties and Corrigendum1:2003
Test Methods
------------------------------------------------------------------------
43 Ophthalmic Optics--Contact Lenses and ISO 11981:1999/
Contact Lens Care Products-- Corrigendum1:2005
Determination of Physical
Compatibility of Contact Lens Care
Products with Contact Lenses
------------------------------------------------------------------------
45 Ophthalmic Optics--Contact Lenses--Part ISO 18369-2:2006
2: Tolerances
------------------------------------------------------------------------
46 Ophthalmic Optics--Contact Lenses--Part ISO 18369-3:2006
3: Measurement Methods
------------------------------------------------------------------------
48 Ophthalmic Implants--Intraocular ISO 11979-5:2006
Lenses--Part 5: Biocompatibility
------------------------------------------------------------------------
49 Ophthalmic Implants--Intraocular ISO 11979-9:2006
Lenses--Part 9: Multifocal Intraocular
Lenses
------------------------------------------------------------------------
50 Ophthalmic implants--Intraocular ISO 11979-10:2006
lenses--Part 10: Phakic Intraocular
Lenses
------------------------------------------------------------------------
51 Ophthalmic Instruments--Fundamental ISO 15004-2:2007
Requirements and Test Methods Part 2:
Light Hazard Protection
------------------------------------------------------------------------
F. Radiology
------------------------------------------------------------------------
165 ``Quality Control Manual'' Template for NEMA XR 22-2006
Manufacturers of Displays and
Workstations Labeled for Final
Interpretation in Full-field Digital
Mammography
------------------------------------------------------------------------
166 ``Quality Control Manual'' Template for NEMA XR 23-2006
Manufacturers of Hardcopy Output
Devices Labeled for Final
Interpretation in Full-field Digital
Mammography
------------------------------------------------------------------------
G. Sterility
------------------------------------------------------------------------
201 Containment Devices for Reusable ANSI/AAMI ST77:2006
Medical Device Sterilization
------------------------------------------------------------------------
220 Comprehensive Guide to Steam ANSI/AAMI ST79:2006
Sterilization and Sterility Assurance
in Health Care Facilities
------------------------------------------------------------------------
[[Page 52153]]
222 Sterilization of Health Care Products-- ANSI/AAMI/ISO
Biological and Chemical Indicators-- 18472:2006
Test Equipment
------------------------------------------------------------------------
223 Sterilization of Health Care Products-- ANSI/AAMI/ISO 11138-
Biological Indicators--Part 1: General 1:2006
Requirements
------------------------------------------------------------------------
224 Sterilization of Health Care Products-- ANSI/AAMI/ISO 11137-
Radiation--Part 1: Requirements for 1:2006
the Development, Validation and
Routine Control of a Sterilization
Process for Medical Devices
------------------------------------------------------------------------
225 Sterilization of Health Care Products-- ANSI/AAMI/ISO 11137-
Radiation--Part 2: Establishing the 2:2006
Sterilization Dose
------------------------------------------------------------------------
226 Sterilization of Health Care Products-- ANSI/AAMI/ISO 11137-
Radiation--Part 3: Guidance on 3:2006
Dosimetric Aspects
------------------------------------------------------------------------
H. Tissue Engineering
------------------------------------------------------------------------
9 Standard Guide for Classification of ASTM F2311-06
Therapeutic Skin Substitutes
------------------------------------------------------------------------
10 Standard Guide for in vivo Assessment ASTM F2451-05
of Implantable Devices Intended to
Repair or Regenerate Articular
Cartilage
------------------------------------------------------------------------
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 Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm. FDA will incorporate the modifications and
minor 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 minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (See FOR FURTHER INFORMATION CONTACT). 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 includes the guidance as well as
the current list of recognized standards and other standards related
documents. After publication in the Federal Register, this notice
announcing ``Modification to the List of Recognized Standards,
Recognition List Number: 018'' will be available on the CDRH home page.
You may access the CDRH home page at http://www.fda.gov/cdrh.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at http://www.fda.gov/cdrh/stdsprog.html.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. 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: 018. These modifications to the list or recognized standards
are effective upon publication of this notice in the Federal Register.
Dated: August 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-18021 Filed 9-11-07; 8:45 am]
BILLING CODE 4160-01-S