59240 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

Division of Small Manufacturers 

Assistance (HFZ–220), Center for 

Devices and Radiological Health, 1350 

Piccard Dr., Rockville, MD 20850–4307, 

Manufacturers Assistance: 800–638–

2041 or 301–443–6597; or the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit telephone requests to 800–835–

4709 or 301–827–1800. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Joseph Salewski, Center for Drug 

Evaluation and Research (HFD–45), 

Food and Drug Administration, 

7520 Standish Pl., Rockville, MD 

20855, 301–594–0020; or

Patricia Holobaugh, Center for 

Biologics Evaluation and Research 

(HFM–664), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–6347; or

John Murray, Jr., Center for Devices 

and Radiological Health (HFZ–340), 

Food and Drug Administration, 

2094 Gaither Rd., Rockville, MD 

20850, 301–594–4646, ext. 107; or

John Welsh, Center for Food Safety 

and Applied Nutrition (HFS–205), 

Food and Drug Administration, 

1110 Vermont Ave., NW, 

Washington, DC 20005, 202–418–

3057; or

Vernon Toelle, Center for Veterinary 

Medicine (HFV–234), Food and 

Drug Administration, 7519 Standish 

Pl., Rockville, MD 20835, 301–827–

0312; or

James McCormack, Office of 

Enforcement (HFC–230), Food and 

Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20857, 301–827–

0425; or

Patricia Beers Block, Good Clinical 

Practice Programs (HF–34), Food 

and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3340.

SUPPLEMENTARY INFORMATION: 

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Computerized Systems Used in 

Clinical Trials.’’ This document 

provides guidance about computerized 

systems that are used to create, modify, 

maintain, archive, retrieve, or transmit 

clinical data required to be maintained 

and/or submitted to FDA. These data 

form the basis for the agency’s decisions 

regarding the safety and effectiveness of 

new human and animal drugs, 

biological products, medical devices, 

and certain food and color additives. As 

such, these data have broad public 

health significance and are expected to 

be of the highest quality and integrity.

This draft guidance, when finalized, 

will supercede the guidance of the same 

name issued in April 1999. This draft 

guidance is being revised to make it 

consistent with agency policy as 

reflected in the guidance for industry on 

‘‘Part 11, Electronic Records; Electronic 

Signatures—Scope and Application,’’

which issued in August 2003. It also 

reflects policy consistent with regard to 

the agency’s international 

harmonization efforts.

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). This draft guidance, when 

finalized, will represent the agency’s 

current thinking on computerized 

systems used in clinical trials. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if the approach 

satisfies the requirements of the 

applicable statute and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

paper copies of any comments are to be 

submitted, 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. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Copies of this draft guidance for 

industry are available on the Internet at 

http://www.fda.gov/cder/guidance/

index.htm, http://www.fda.gov/cber/

guidelines.htm, http://www.fda.gov/

cvm/guidance/guidance.html, and http:/

/www.fda.gov/oc/gcp/draft.html.

Dated: September 28, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22204 Filed 9–29–04; 1:51 pm]

BILLING CODE 4160–01–S

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: 

011

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: 011’’ (Recognition List 

Number: 011), 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 on a 3.5′′ diskette of 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

011’’ to the Division of Small 

Manufacturers 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: standards@cdrh.fda.gov. This 

document may also be accessed on 

FDA’s Internet site at http://

www.fda.gov/cdrh/fedregin.html. 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: 011 

modifications and other standards 

related information.

FOR FURTHER INFORMATION CONTACT:

Carol L. Herman, Center for Devices and 

Radiological Health (HFZ–84), Food and 

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59241

Drug Administration, 2094 Gaither Rd., 

Rockville, MD 20850, 301–594–4766, 

ext.156.

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 will 

implement its standard recognition 

program and provided the initial list of 

FDA recognized consensus standards.

In Federal Register notices published 

on October 16, 1998 (63 FR 55617), July 

12, 1999 (64 FR 37546), November 15, 

2000 (65 FR 69022), May 7, 2001 (66 FR 

23032), January 14, 2002 (67 FR 1774), 

October 2, 2002 (67 FR 61893), April 28, 

2003 (68 FR 22391), March 8, 2004 (69 

FR 10712), and June 18, 2004 (69 FR 

34176), FDA modified its initial list of 

FDA recognized consensus standards. 

These notices described 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 Recognition List 

Number: 011

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: 011’’ to 

identify these current modifications.

In table 1 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 1.

Old Item 

No. Standard Change Replacement Item No. 

A. Anesthesia

1 ASTM F920–93 (1999), Standard Specification for Minimum Performance and Safety 

Requirements for Resuscitators Intended for Use With Humans

Withdrawn and replaced 

with newer version

50

2 ASTM F1100–90 (1997), Standard Specification for Ventilators Intended for Use in 

Critical Care

Withdrawn and replaced 

with newer version

51

5 ASTM F1463–93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory CareWithdrawn and replaced 

with newer version

52

6 ASTM F1464–93 (1999), Standard Specification for Oxygen Concentrators for Domiciliary UseWithdrawn and replaced 

with newer version

53

8 PVHO–1–2002, Safety Standard for Pressure Vessels for Human Occupancy Withdrawn and replaced 

with newer version

54

23 ASTM F1054–01, Standard Specification for Conical Fittings Withdrawn and replaced 

with newer version

55

24 ASTM F1456–01, Standard Specification for Minimum Performance and Safety Requirements for CapnometersWithdrawn and replaced 

with newer version

59

25 ASTM F1462–93, Specification for Oxygen Analyzers Withdrawn

34 ASTM PS127: 2000, Standard Test Method for Evaluating the Ignition Sensitivity and 

Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications

Withdrawn

40 CGA V–7.1: 1997 (reaffirmed 2003), Standard Method for Determining Cylinder Valve 

Outlet Connections for Medical Gases

Withdrawn and replaced 

with newer version

56

45 ASTM 1101–90 (2003) e1, Standard Specification for Ventilators Intended for Use 

During Anesthesia

Withdrawn and replaced 

with newer version

57

B. Cardiovascular/Neurology

59242 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

TABLE 1.—Continued

Old Item 

No. Standard Change Replacement Item No. 

1 ANSI/AAMI EC12: 2000, Disposable Electrocardiogram (ECG) Electrodes Withdrawn and replaced 

with newer version

52

4 AAMI SP10: 1992, Electronic or Automated Sphygmomanometers Change in processes affected and contact 

person

44 ANSI/AAMI BP22: 1994 (R2001), Blood Pressure Transducers Change in processes affected and contact 

person

C. Dental/Ear, Nose, and Throat

22 ASTM/F1377–92, Standard Specification for Cobalt-Chromium-Molybdenum Powder 

for Coating of Orthopaedic Implants

Transfer to materials

42 ANSI/ADA Specification No. 3: 1994, Dental Impression Compound Withdrawn

43 ANSI/ADA Specification No. 5: 1997, Dental Casting Alloys Change date of standard

44 ANSI/ADA Specification No. 11: 1997, Agar Impression Material Withdrawn and replaced 

with newer version

110

45 ANSI/ADA Specification No. 13: 1999, Dental Cold-Curing Repair Resin Withdrawn and replaced 

with newer version

111

48 ANSI/ADA Specification No. 16: 1999, Dental Impression Paste Zinc Oxide-Eugenol 

Materials

Withdrawn and replaced 

with newer version

112

51 ANSI/ADA Specification No. 20: 1995, Dental Duplicating Material Withdrawn and replaced 

with newer version

113

55 ANSI/ADA Specification No. 48: 1989, Ultraviolet Activator and Disclosing Lights Withdrawn and replaced 

with newer version

114

67 ISO 6871–1: 1994, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based Alloys—

Technical Corrigendum 1: 1998

Title correction

80 ISO 9917–1: 2003, Dental Water Based Cements—Part 1: Powder/Liquid Acid-Base 

Cements—first edition

Withdrawn and replaced 

with newer version

115

81 ISO 10139–1: 1999, Dentistry—Resilient Lining Materials for Removable Dentures—

Part 1: Short-Term Materials

Withdrawn and replaced 

with newer version

116

90 ANSI/ASA S3.39: 1987 (R2002), Specification for Instruments to Measure Aural 

Acoustic Impedance and Admittance (Aural Acoustic Immittance)

Change date of standard

103 ANSI/ADA Specification No. 12: 2002, Denture Base Polymers Withdrawn and replaced 

with newer version

117

105 ANSI/ADA Specification No. 75: 1997 (R2003), Resilient Lining Materials for Removable Dentures—Part 1: Short-Term MaterialsTitle correction

106 ANSI/ADA Specification No. 82: 2003, Dental Reversible/Irreversible Hydrocolloid Impression Material SystemWithdrawn and replaced 

with newer version

119

108 ISO 10139–2: 1999, Dentistry—Soft Lining Materials for Removable Dentures—Part 2: 

Materials for Long-Term Use

Withdrawn and replaced 

with newer version

120

D. General

10 AAMI/ISO 14971–1, Medical Devices—Risk Management—Part 1: Application of Risk 

Analysis

Withdrawn

21 CEN EN 1441: 1997, Medical Devices—Risk Management Withdrawn

E. In Vitro Diagnostic

23 NCCLS H1–A5, Tubes and Additives for Venous Blood Specimen Collection; Approved StandardWithdrawn and replaced 

with newer version

102

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59243

TABLE 1.—Continued

Old Item 

No. Standard Change Replacement Item No. 

69 NCCLS H3–A5, Procedures for the Collection of Diagnostic Blood Specimens by 

Venipuncture; Approved Standard

Withdrawn and replaced 

with newer version

103

24 NCCLS H7–A3, Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—third editionWithdrawn and replaced 

with newer version

104

33 NCCLS H30–A2, Procedure for the Determination of Fibrinogen in Plasma; Approved 

Guideline—second edition

Withdrawn and replaced 

with newer version

105

57 NCCLS M2–A8, Performance Standards for Antimicrobial Disk Susceptibility Tests; 

Approved Standard—eighth edition

Withdrawn and replaced 

with newer version

106

75 NCCLS M11–A6, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria 

That Grow Aerobically, Approved Standard—sixth edition

Withdrawn and replaced 

with newer version

107

56 NCCLS M7–A6, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; 

Approved Standard—sixth edition

Withdrawn and replaced 

with newer version

108

F. Materials

5 ASTM F138–03, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)Withdrawn and replaced 

with newer version

76

6 ASTM F139–03, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Withdrawn and replaced 

with newer version

77

7 ASTM F560–04, Standard Specification for Unalloyed Tantalum for Surgical Implant 

Applications (UNS R05200, UNS R05400)

Withdrawn and replaced 

with newer version

78

13 ASTM F648–00e1, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsChange date of standard

16 ASTM F746–87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsChange in processes affected

19 ASTM F961–03, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)Withdrawn and replaced 

with newer version

79

21 ASTM F1088–04, Standard Specification for Beta-Tricalcium Phosphate for Surgical 

Implantation

Withdrawn and replaced 

with newer version

80

33 ASTM F1609–03, Standard Specification for Calcium Phosphate for Coatings for 

Implantable Materials

Withdrawn and replaced 

with newer version

81

34 ASTM F1659–95, Standard Test Method for Bending and Shear Fatigue Testing of 

Calcium Phosphate Coatings on Solid Metallic Substrates

Change in processes affected

35 ASTM F1713–03, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant ApplicationsWithdrawn and replaced 

with newer version

82

40 ASTM F2063–00, Standard Specification for Wrought Nickel-Titanium Shape Memory 

Alloys for Medical Devices and Surgical Implants

Change in extent of recognition, contact person, and processes 

affected

42 ASTM F2119–01, Standard Test Method for Evaluation of MR Image Artifacts From 

Passive Implants

Change in processes affected

48 ASTM F899–02, Standard Specification for Stainless Steel for Surgical Instruments Change in processes affected

70 ASTM F2052–02, Standard Test Method for Measurement of Magnetically Induced 

Displacement Force on Medical Devices in the Magnetic Resonance Environment

Withdrawn

72 ASTM F2213–04, Standard Test Method for Measurement of Magnetically Induced 

Torque on Medical Devices in the Magnetic Resonance Environment

Change in processes affected

Ortho 

#91

ASTM F561–97 (2003), Practice for Retrieval and Analysis of Implanted Medical Devices and Associated TissuesTransferred to materials 73

59244 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

TABLE 1.—Continued

Old Item 

No. Standard Change Replacement Item No. 

Ortho 

#93

ASTM 601–03, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsTransferred to materials 94

Ortho 

#107

ASTM F1147–99, Standard Test Method for Tension Testing of Calcium Phosphate 

and Metal Coating

Transferred to materials 84

Ortho/PM 

#113 

Dental #

22

ASTM F1377–98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum 

Powder for Coating of Orthopedic Implants (UNS R30075)

Transferred to materials 74

Ortho 

#124

ASTM F86–01, Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsTransferred to materials 93

Ortho 

#131

ASTM F1044–99, Standard Test Method for Shear Testing of Calcium Phosphate 

Coatings and Metallic Coatings

Transferred to materials 83

Ortho 

#152

ASTM F1160–00e1, Standard Test Method for Shear and Bending Fatigue Testing of 

Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

Transferred to materials 75

Ortho 

#160

ASTM F629–02, Standard Practice for Radiography of Cast Metallic Surgical Implants Transferred to materials 95

G. OB–GYN/Gastroenterology

16 AAMI/ANSI ID54: 1996 (R)2001, Enteral Feeding Set Adapters and Connectors Withdrawn and replaced 

with newer version

31

H. Orthopaedic

58 ASTM F1781–03, Standard Specification for Elastomeric Flexible Hinge Finger Total 

Joint Implants

Withdrawn and replaced 

with newer version

168

91 ASTM F561–97, Practice for Retrieval and Analysis of Implanted Medical Devices and 

Associated Tissues

Transferred to materials 73

93 ASTM F601–98, Standard Practice for Fluorescent Penetrant Inspection of Metallic 

Surgical Implants

Transferred to materials 94

107 ASTM F1147–99, Standard Test Method for Tension Testing of Calcium Phosphate 

and Metal Coatings

Transferred to materials 84

111 ASTM F1814–97a (2003), Standard Guide for Evaluating Modular Hip and Knee Joint 

Components

Withdrawn and replaced 

with newer version

171

113 ASTM F1377–98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum 

Powder for Coating of Orthopedic Implants (UNS R30075)

Transferred to materials 74

114 ASTM F1798–97 (2003), Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis ImplantsWithdrawn and replaced 

with newer version

172

115 ASTM F1800–97 (2003), Standard Test Method for Cyclic Fatigue Testing of Metal 

Tibial Tray Components of Total Knee Joint Replacements

Withdrawn and replaced 

with newer version

173

120 ASTM F382–99 (2003), Standard Specification and Test Method for Metallic Bone 

Plates

Withdrawn and replaced 

with newer version

174

124 ASTM F86–01, Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsTransferred to materials 93

131 ASTM F1044–99, Standard Test Method for Shear Testing of Calcium Phosphate 

Coatings and Metallic Coatings

Transferred to materials 83

140 ASTM F1582–98 (2003), Standard Terminology Relating to Spinal Implants Withdrawn and replaced 

with newer version

175

145 ASTM F565–00 (2003), Standard Practice for Care and Handling of Orthopedic Implants and InstrumentsWithdrawn and replaced 

with newer version

176

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59245

TABLE 1.—Continued

Old Item 

No. Standard Change Replacement Item No. 

152 ASTM F1160–00e1, Standard Test Method for Shear and Bending Fatigue Testing of 

Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

Transferred to materials 75

160 ASTM F629–02, Standard Practice for Radiography of Cast Metallic Surgical Implants Transferred to materials 95

161 ASTM F1264–03, Standard Specification and Test Methods for Intramedullary Fixation 

Devices

Withdrawn and replaced 

with newer version

177

165 ISO 7206–4: 2002, Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 

4: Determination of Endurance Properties of Stemmed Femoral Components

Withdrawn

I. Physical Medicine

1 ANSI/RESNA WC/volume—1998, Section 1: Determination of Static Stability Withdrawn and replaced 

with newer version

31

2 ANSI/RESNA WC/volume 2—1998, Section 2: Determination of Dynamic Stability of 

Electric Wheelchairs

Withdrawn and replaced 

with newer version

32

3 ANSI/RESNA WC/volume 2—1998, Section 3: Test Methods and Requirements for 

the Effectiveness of Brakes

Withdrawn and replaced 

with newer version

33

4 ANSI/RESNA WC/volume 2—1998, Section 4: Determination of Energy Consumption 

of Electric Wheelchairs and Scooters—Theoretical Range

Withdrawn and replaced 

with newer version

34

5 ANSI/RESNA WC/volume 1—1998, Section 5: Determination of Overall Dimensions, 

Mass, and Turning Space

Withdrawn and replaced 

with newer version

35

6 ANSI/RESNA WC/volume 2—1998, Section 6: Determination of Maximum Speed, Acceleration, and Retardation of Electric WheelchairsWithdrawn and replaced 

with newer version

36

7 ANSI/RESNA WC/volume 1—1998, Section 7: Method of Measurement of Seating and 

Wheel Dimensions

Withdrawn and replaced 

with newer version

37

8 ANSI/RESNA WC/volume 1—1998, Section 8: Requirements and Test Methods for 

Static, Impact, and Fatigue Strengths

Withdrawn and replaced 

with newer version

38

9 ANSI/RESNA WC/volume 2—1998, Section 9: Climatic Tests for Electric Wheelchairs Withdrawn and replaced 

with newer version

39

10 ANSI/RESNA WC/volume 2—1998, Section 10: Determination of Obstacle-Climbing 

Ability of Electric Wheelchairs

Withdrawn and replaced 

with newer version

40

11 ANSI/RESNA WC/volume 1—1998, Section 11: Test Dummies Withdrawn and replaced 

with newer version

41

12 ANSI/RESNA WC/volume 1—1998, Section 13: Determination of Coefficient of Friction 

of Test Surfaces

Withdrawn and replaced 

with newer version

42

13 ANSI/RESNA WC/volume 2—1998, Section 14: Power and Control Systems for Electric Wheelchairs—Requirements and Test MethodsWithdrawn and replaced 

with newer version

43

14 ANSI/RESNA WC/volume 1—1998, Section 15: Requirements for Information Disclosure, Documentation, and LabelingWithdrawn and replaced 

with newer version

44

15 ANSI/RESNA WC/volume 1—1998, Section 16: Resistance to Ignition of Upholstered 

Parts—Requirements and Test Methods

Withdrawn and replaced 

with newer version

45

18 ISO 7176–3: 2003, Wheelchairs—Part 3: Determination of Effectiveness of Brakes Withdrawn and replaced 

with newer version

50

J. Radiology

39 IEC 60601–2–17, Medical Electrical Equipment—Part 2: Particular Requirements for 

the Safety of Remote-Controlled Automatically-Drive Gamma-Ray Afterloading 

Equipment (1989) Amendment No. 1 to IEC 601–2–17 (1996)

Withdrawn

71 NEMA UD 2–2004, Revision 3: Acoustic Output Measurement Standard for Diagnostic 

Ultrasound Equipment

Withdrawn and replaced 

with newer version

105

59246 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

TABLE 1.—Continued

Old Item 

No. Standard Change Replacement Item No. 

72 NEMA UD 3–2004, Revision 2: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound EquipmentWithdrawn and replaced 

with newer version

100

78 NEMA PS 3, Set: Digital Imaging and Communications in Medicine (DICOM) Set Withdrawn and replaced 

with newer version

119

86 IEC 60601–2–33 (2002–05), Medical Electrical Equipment—Part 2–33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical DiagnosisWithdrawn and replaced 

with newer version

104

88 IEC 60601–2–17 (2004–01), Medical Electrical Equipment—Part 2–17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading 

Equipment

Withdrawn and replaced 

with newer version

118

94 IEC 60731 Amendment 1 (2002–06), Medical Electrical Equipment—Dosimeters With 

Ionization Chambers as Used in Radiotherapy

Withdrawn and replaced 

with newer version

98

K. Sterility

16 ANSI/AAMI ST35: 2003, Safe Handling and Biological Decontamination of Reusable 

Medical Devices in Health Care Facilities and in Nonclinical Settings

Withdrawn and replaced 

with newer version

117

17 ANSI/AAMI ST44: 1992, BIER/EO Gas Vessels Withdrawn

18 ANSI/AAMI ST45: 1992, BIER/Steam Vessels Withdrawn

20 ANSI/AAMI ST50: 2004, Dry Heat (Heated Air) Sterilizers Withdrawn and replaced 

with newer version

118

21 ANSI/AAMI ST55: 2003, Table-Top Steam Sterilizers Withdrawn and replaced 

with newer version

119

48 ANSI/AAMI ST40: 1992/(R)1998, Table-Top Dry Heat (Heated Air) Sterilizers and Sterility Assurance in Dental and Medical FacilitiesChange in relevant guidance and contact person

50 ANSI/AAMI ST42: 1998, Steam Sterilization and Sterility Assurance Using Table-Top 

Sterilizers in Office-Based, Ambulatory-Care Medical, Surgical, and Dental Facilities

Contact person

52 ANSI/AAMI ST59: 1999, Sterilization of Health Care Products—Biological Indicators—

Part 1: General Requirements

Change in relevant guidance

53 ANSI/AAMI ST66: 1999, Sterilization of Health Care Products—Chemical Indicators—

Part 2: Class 2 Indicators for Air Removal Test Sheets and Packs

Contact person

56 ASTM D3078: 2002, Standard Test Method for Determination of Leaks in Flexible 

Packaging by Bubble Emission

Withdrawn and replaced 

with newer version

120

57 ASTM D4169: 2004, Standard Practice for Performance Testing of Shipping Containers and SystemsWithdrawn and replaced 

with newer version

121

58 ASTM F88: 2000, Standard Test Method for Seal Strength of Flexible Barrier Materials Withdrawn and replaced 

with newer version

122

63 ASTM F1886: 1998 (2004), Standard Test Method for Determining Integrity of Seals 

for Medical Packaging by Visual Inspection

Reaffirmation

64 ASTM F1929: 1998 (2004), Standard Test Method for Detecting Seal Leaks in Porous 

Medical Packaging by Dye Penetration

Reaffirmation

72 ANSI/AAMI ST33: 1996, Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in 

Health Care Facilities

Contact person

74 ANSI/AAMI ST60: 1996, Sterilization of Health Care Products—Chemical Indicators—

Part 1: General Requirements

Contact person

75 ANSI/AAMI/ISO 11137: 1994, Sterilization of Health Care Products—Requirements for 

Validation and Routine Control—Radiation Sterilization and ANSI/AAMI/ISO 11137: 

1994/Amendment 1: 2002

Change in title, relevant 

guidance, and contact 

person

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59247

TABLE 1.—Continued

Old Item 

No. Standard Change Replacement Item No. 

91 ASTM F2096: 2004, Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)Withdrawn and replaced 

with newer version

123

103 AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical Devices Change in relevant guidance

105 ANSI/AAMI ST46: 2002, Steam Sterilization and Sterility Assurance in Health Care FacilitiesContact person

106 USP 27: 2004, Biological Indicator for Dry Heat Sterilization, Paper Carrier Withdrawn and replaced 

with newer version

124

107 USP 27: 2004, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier Withdrawn and replaced 

with newer version

125

108 USP 27: 2004, Biological Indicator for Steam Sterilization, Paper Carrier Withdrawn and replaced 

with newer version

126

109 USP 27: 2004, <61> Microbial Limits Test Withdrawn and replaced 

with newer version

127

110 USP 27: 2004, <71> Microbiological Tests, Sterility Tests Withdrawn and replaced 

with newer version

128

111 USP 27: 2004, <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL) Withdrawn and replaced 

with newer version

129

112 USP 27: 2004, <151> Pyrogen Test (USP Rabbit Test) Withdrawn and replaced 

with newer version

130

113 USP 27: 2004, <1211> Sterilization and Sterility Assurance of Compendial Articles Withdrawn and replaced 

with newer version

131

114 USP 27: 2004, <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced 

with newer version

132

115 USP 27: 2004, Biological Indicator for Steam Sterilization—Self-Contained Withdrawn and replaced 

with newer version

133

116 ANSI/AAMI ST72: 2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch TestingChange in relevant guidance

III. Listing of New Entries

The listing of new entries and 

consensus standards added as 

modifications to the list of recognized 

standards, under Recognition List 

Number: 011, follows:

TABLE 2.

Item No. Title of Standard Reference No. and Date 

A. Anesthesia

58 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen 

Regulators Used for Medical and Emergency Applications

ASTM G175–03

B. Dental/ENT

121 Dentistry—Dental Units—Part 2: Water and Air Supply ISO 7494–2: 2003

C. General Hospital/General Plastic Surgery

112 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for 

Use in Health Care Facilitates

ANSI/AAMI PB70: 2003

113 Standard Specification for Performance of Materials Used in Medical Face Masks ASTM F2100–04

D. Materials

59248 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

TABLE 2.—Continued

Item No. Title of Standard Reference No. and Date 

85 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants ASTM F1854–01

86 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate CoatingsASTM F1926–03

87 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings 

by Using the TaberT Abraser

ASTM F1978–00e1

88 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed 

Hydroxyapatite Coatings

ASTM F2024–00

89 Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y–

TZP) for Surgical Implant Applications

ASTM F1873–98

90 Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension 

Loading

ASTM F2255–03

91 Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension LoadingASTM F2256–03

92 Standard Test Method for Strength Properties of Tissue Adhesives in Tension ASTM F2258–03

96 Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical ImplantsASTM 1635–95 (2000)

97 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesASTM F2129–04

98 Standard Specification for Acrylic Bone Cement ASTM F451–99ae1

99 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal 

Analysis

ASTM F2004–03

100 Standard Terminology for Nickel-Titanium Shape Memory Alloys ASTM F2005–00

101 Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement MaterialsASTM F2118–03

102 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium 

Shape Memory Alloys by Bend and Free Recovery

ASTM F2082–03

E. OB–GYN/Gastroenterology

30 Water Treatment Equipment for Hemodialysis Applications ANSI/AAMI RD62: 2001

F. Ophthalmic

33 Contact Lens Care Products—Vocabulary, Performance Specifications, and Test Methodology ANSI Z80.18

G. Orthopaedic

178 Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral 

Components Without Torsion

ASTM F1440–92 (2002)

179 Standard Specification for Femoral Prostheses—Metallic Implants ASTM F2068–03

H. Physical Medicine

46 Determination of Performance of Stand-Up Type Wheelchairs ANSI/RESNA WC/volume 

1—1998, section 20

47 Set Up Procedures ANSI/RESNA WC/volume 

1—1998, section 22

48 Maximum Overall Dimensions ANSI/RESNA WC/volume 

1—1998, section 93

49 Nomenclature, Terms, and Definitions ANSI/RESNA WC/volume 

1—1998, section 0

I. Radiology

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59249

TABLE 2.—Continued

Item No. Title of Standard Reference No. and Date 

101 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General RequirementsANSI/ESNA RP–27.1.96

102 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement TechniquesANSI/ESNA RP–27.2.00

103 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Risk Group 

Classification and Labeling

ANSI/ESNA RP–27.3.96

106 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Lifetime of Lasers ISO 17526: 2003

107 Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Beam 

Widths, Divergence Angle, and Beam Propagation Factor

ISO 11146: 1999

108 Lasers and Laser-Related Equipment—Determination of Laser-Induced Damage Threshold of 

Optical Surfaces—Part 1: 1-on-1 Test

ISO 11254–1: 2000

109 Lasers and Laser-Related Equipment—Determination of Laser-Induced Damage Threshold of 

Optical Surfaces—Part 2: S-on-1 Test

ISO 11254–2: 2001

110 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for Absorptance of Optical Laser Components (revision of ISO 11551: 1997)ISO 11551: 2003

111 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Methods for Laser 

Beam Power, Energy, and Temporal Characteristics (revision of ISO 11554: 1998)

ISO 11554: 2003

112 Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Beam Positional Stability (revision of ISO 11670: 1999)ISO 11670: 2003

113 Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Polarization 

(revision of ISO 12005: 1999)

ISO 12005: 2003

114 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Methods for Laser 

Beam Power (Energy) Density Distribution

ISO 13694: 2000

115 Optics and Photonics—Lasers and Laser-Related Equipment—Test Methods for the Spectral 

Characteristics of Lasers

ISO 13695: 2004

116 Optics and Optical Instruments—Test Methods for Radiation Scattered by Optical Components ISO 13696: 2002

117 Lasers and Laser-Related Equipment—Test Methods for Determination of the Shape of a Laser 

Beam Wavefront—Part 1: Terminology and Fundamental Aspects

ISO 15367–1: 2003

120 Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography IEC 60601–2–44 (ed. 2.1)

J. Sterility

134 Resistometers Used for Characterizing the Performance of Biological and Chemical Indicators ANSI/AAMI ST44: 2002

135 Sterilization of Health Care Products—Requirements for the Development, Validation, and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry HeatANSI/AAMI ST63: 2002

136 Sterilization of Health Care Products—Requirements for Products Labeled ‘‘Sterile’’ ANSI/AAMI ST67: 2003

137 Sterilization of Health Care Products—Vocabulary ANSI/AAMI/ISO TIR 

11139: 2002

138 Aseptic Processing of Health Care Products—Part 2: Filtration ISO 13408–2: 2003

139 Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness ISO 14644–1: 1999

140 Cleanrooms and Associated Controlled Environments—Part 2: Specifications for Testing and 

Monitoring to Prove Continued Compliance With ISO 14644–1

ISO 14644–2: 2000

141 Cleanrooms and Associated Controlled Environments—Part 4: Design, Construction, and StartUpISO 14644–4: 2001

142 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 1: General Principles and MethodsISO 14698–1: 2003

143 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 2: Evaluation and Interpretation of Biocontamination DataISO 14698–2: 2003

59250 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

TABLE 2.—Continued

Item No. Title of Standard Reference No. and Date 

K. Tissue Engineering

5 Standard Guide for Characterization and Testing of Hyaluronan as Starting Material Intended for 

Use in Biomedical and Tissue Engineered Medical Product Applications

ASTM F2347–2003

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 minor revisions 

described in this document 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

In order to receive ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards’’ via your fax machine, call 

the Center for Devices and Radiological 

Health (CDRH) Facts-On-Demand 

system at 800–899–0381 or 301–827–

0111 from a touch-tone telephone. Press 

1 to enter the system. At the second 

voice prompt press 1 to order a 

document. Enter the document number 

321 followed by the pound sign. Follow 

the remaining voice prompts to 

complete your request.

You may also obtain a copy of 

‘‘Guidance on the Recognition and Use 

of Consensus Standards’’ by using the 

Internet. 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 document 

announcing ‘‘Modifications to the List 

of Recognized Standards, Recognition 

List Number: 011,’’ 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.fda.gov/cdrh/fedregin.html.

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. Two copies of any mailed 

comments are to be submitted, 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: 

011. These modifications to the list or 

recognized standards are effective upon 

publication of this document in the 

Federal Register.

Dated: September 21, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–22183 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0117]

Guidance for Industry, Food and Drug 

Administration Staff, and Third Parties; 

Implementation of the Inspection by 

Accredited Persons Program Under 

the Medical Device User Fee and 

Modernization Act of 2002; 

Accreditation Criteria; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is revising the 

criteria the agency will use to accredit 

persons for the purpose of conducting 

inspections of eligible device 

manufacturers under the Medical 

Device User Fee and Modernization Act 

of 2002 (MDUFMA), which established 

an ‘‘inspection by accredited persons’’

program. FDA is also announcing the 

availability of a revised guidance 

document that will provide information 

for those interested in participating in 

this program. The guidance is entitled 

‘‘Implementation of the Inspection by 

Accredited Persons Program Under the 

Medical Device User Fee and 

Modernization Act of 2002; 

Accreditation Criteria.’’ This revised 

guidance document is immediately in 

effect, but it remains subject to comment 

in accordance with the agency’s good 

guidance practices. FDA is taking these 

actions to implement recent technical 

amendments to MDUFMA.

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled 

‘‘Implementation of the Inspection by