Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 015

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: 015

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: 015” (Recognition List Number: 015), 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: 015” to the Division of Small Manufacturers, 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:

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: 015 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, 12720 Twinbrook Pkwy., MD 20857, 301-827-0021.

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.

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), June 18, 2004 (69 FR 34176), October 4, 2004 (69 FR 59240), May 27, 2005 (70 FR 30756), November 8, 2005 (70 FR 67713), and March 31, 2006 (71 FR 16313), FDA modified its initial list of FDA recognized consensus standards.

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: 015

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: 015” 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. Biocompatibility

21

AAMI/ANSI/ISO10993-11:1993, Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity

Extent of recognition

66

ASTM F2148-01, Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay

Contact person, processes affected, and extent of recognition

67

ASTM F756-00, Standard Practice for Assessment of Hemolytic Properties of Materials

Contact person, processes affected, and extent of recognition

73

ASTM F2065-00e1, Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials

Contact person, processes affected, and extent of recognition

82

ASTM F2147-01, Standard Practice for Guinea Pigs: Split Adjuvant and Closed Patch Testing for Contact Allergens

Contact person, and processes affected

101

USP 29-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version

109

102

USP 29-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution Test

Withdrawn and replaced with newer version

110

103

USP 29-NF21Biological Tests <88>, Biological Reactivity Test, In Vivo Procedure—Preparation of Sample

Withdrawn and replaced with newer version

111

104

USP 29-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test

Withdrawn and replaced with newer version

112

105

USP 29-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Systemic Injection Test

Withdrawn and replaced with newer version

113

B. Dental/Ear, Nose, and Throat

83

ISO 11498 Dental Handpieces: Dental Low Voltage Electrical Motors

Contact person, and processes affected

127

ANSI/ADA Specification No. 58:2004, Root Canal Files, Type H (Hedstrom)

Contact person

C. General Hospital/General Plastic Surgery

133

USP 29: 2006 Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version

151

134

USP 29<11>: 2006 Sterile Sodium Chloride for Irrigation

Withdrawn and replaced with newer version

152

135

USP 29: 2006 Absorbable Surgical Suture

Withdrawn and replaced with newer version

153

136

USP 29<881>: 2006 Tensile Strength

Withdrawn and replaced with newer version

154

137

USP 29<861>: 2006 Sutures—Diameter

Withdrawn and replaced with newer version

155

138

USP 29<871>: 2006 Sutures Needle Attachment

Withdrawn and replaced with newer version

156

139

USP 29<11>: 2006 Sterile Water for Irrigation

Withdrawn and replaced with newer version

157

140

USP 29<11>: 2006 Heparin Lock Flush Solution

Withdrawn and replaced with newer version

158

141

USP 29<11>: 2006 Sodium Chloride Injection

Withdrawn and replaced with newer version

159

D. Sterility

52

ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: General

Contact person and relevant guidance

70

AAMI/ANSI/ISO 14161:2000, Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use and Interpretation of Results, 2 ed.

Contact person

72

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

Contact person and processes affected

94

AOAC 6.2.01:2005, Official Method 955.14, Testing Disinfectants Against Salmonella Choleraesuis, Use-Dilution Method

Withdrawn and replaced with newer version

172

95

AOAC 6.2.02:2005, Official Method 991.47, Testing Disinfectants Against Salmonella Choleraesuis, Hard Surface Carrier Test Method

Withdrawn and replaced with newer version

173

96

AOAC 6.2.03:2005, Official Method 991.48, Testing Disinfectants Against Staphylococcus Aureus, Hard Surface Carrier Test Method

Withdrawn and replaced with newer version

174

97

AOAC 6.2.04:2005, Official Method 955.15, Testing Disinfectants Against Staphylococcus Aureus, Use-Dilution Method

Withdrawn and replaced with newer version

175

98

AOAC 6.2.05:2005, Official Method 991.49, Testing Disinfectants Against Pseudomonas Aeruginosa, Hard Surface Carrier Test Method

Withdrawn and replaced with newer version

176

99

AOAC 6.2.06:2005, Official Method 964.02, Testing Disinfectants Against Pseudomonas Aeruginosa, Use-Dilution Method

Withdrawn and replaced with newer version

177

100

AOAC 6.3.02:2005, Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton Mentagrophytes

Withdrawn and replaced with newer version

178

101

AOAC 6.3.05:2005, Official Method 966.04, Sporicidal Activity of Disinfectants

Withdrawn and replaced with newer version

179

102

AOAC 6.3.06:2005, Official Method 965.12, Tuberculocidal Activity of Disinfectants

Withdrawn and replaced with newer version

180

104

AAMI/ANSI ST58:2005, Safe Use and Handling of Glutaraldehyde-Based Products in Health Care Facilities

Withdrawn and replaced with newer version

181

116

ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing

Relevant guidance

117

ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings

Relevant guidance

153

USP 29:2006, Biological Indicator for Dry Heat Sterilization, Paper Carrier

Withdrawn and replaced with newer version

182

154

USP 29:2006, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier

Withdrawn and replaced with newer version

183

155

USP 29:2006, Biological Indicator for Steam Sterilization, Paper Carrier

Withdrawn and replaced with newer version

184

156

USP29:2006, <61> Microbial Limits Test

Withdrawn and replaced with newer version

185

157

USP 29:2006, <71>, Microbiological Tests, Sterility Tests

Withdrawn and replaced with newer version

186

158

USP29:2006, <85>, Biological Tests and Assays, Bacterial Endotoxin Test (LAL)

Withdrawn and replaced with newer version

187

159

USP29:2006 <151>, Pyrogen Test (USP Rabbit Test)

Withdrawn and replaced with newer version

188

160

USP29:2006 <1211>, Sterilization and Sterility Assurance of Compendial Articles

Withdrawn

161

USP29:2006 <161>, Transfusion and Infusion Assemblies and Similar Medical Devices

Withdrawn and replaced with newer version

189

162

USP 29:2006, Biological Indicator for Steam Sterilization—Self-Contained

Withdrawn and replaced with newer version

190

164

ANSI/AAMI ST81:2004, Sterilization of Medical Devices—Information to be Provided by the Manufacturer for the Processing of Resterilizable Devices

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: 015, follows:

Table 2.

Item No.

Title of Standard

Reference No. and Date

A. Sterility

191

Aseptic Processing of Health Care Products—Part 4: Clean-in-Place Technologies

ISO 13408-4:2005

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 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 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. 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 “Modifications to the List of Recognized Standards, Recognition List Number: 015” 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. 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: 015. These modifications to the list of recognized standards are effective upon publication of this notice in the

Federal Register

.

Dated: June 13, 2006.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

[FR Doc. E6-9959 Filed 6-22-06; 8:45 am]

BILLING CODE 4160-01-S