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Notice

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

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Information about this document as published in the Federal Register.

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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 Start Printed Page 36122searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 015 modifications and other standards related information.

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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.

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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.StandardChangeReplacement Item No.
A. Biocompatibility
21AAMI/ANSI/ISO10993-11:1993, Biological Evaluation of Medical Devices—Part 11: Tests for Systemic ToxicityExtent of recognition
66ASTM F2148-01, Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node AssayContact person, processes affected, and extent of recognition
67ASTM F756-00, Standard Practice for Assessment of Hemolytic Properties of MaterialsContact person, processes affected, and extent of recognition
73ASTM F2065-00e1, Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid MaterialsContact person, processes affected, and extent of recognition
82ASTM F2147-01, Standard Practice for Guinea Pigs: Split Adjuvant and Closed Patch Testing for Contact AllergensContact person, and processes affected
101USP 29-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version109
102USP 29-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version110
103USP 29-NF21Biological Tests <88>, Biological Reactivity Test, In Vivo Procedure—Preparation of SampleWithdrawn and replaced with newer version111
104USP 29-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous TestWithdrawn and replaced with newer version112
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105USP 29-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Systemic Injection TestWithdrawn and replaced with newer version113
B. Dental/Ear, Nose, and Throat
83ISO 11498 Dental Handpieces: Dental Low Voltage Electrical MotorsContact person, and processes affected
127ANSI/ADA Specification No. 58:2004, Root Canal Files, Type H (Hedstrom)Contact person
C. General Hospital/General Plastic Surgery
133USP 29: 2006 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version151
134USP 29<11>: 2006 Sterile Sodium Chloride for IrrigationWithdrawn and replaced with newer version152
135USP 29: 2006 Absorbable Surgical SutureWithdrawn and replaced with newer version153
136USP 29<881>: 2006 Tensile StrengthWithdrawn and replaced with newer version154
137USP 29<861>: 2006 Sutures—DiameterWithdrawn and replaced with newer version155
138USP 29<871>: 2006 Sutures Needle AttachmentWithdrawn and replaced with newer version156
139USP 29<11>: 2006 Sterile Water for IrrigationWithdrawn and replaced with newer version157
140USP 29<11>: 2006 Heparin Lock Flush SolutionWithdrawn and replaced with newer version158
141USP 29<11>: 2006 Sodium Chloride InjectionWithdrawn and replaced with newer version159
D. Sterility
52ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: GeneralContact person and relevant guidance
70AAMI/ANSI/ISO 14161:2000, Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use and Interpretation of Results, 2 ed.Contact person
72ANSI/AAMI ST33:1996, Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for Ethylene Oxide Sterilization in Health Care FacilitiesContact person and processes affected
94AOAC 6.2.01:2005, Official Method 955.14, Testing Disinfectants Against Salmonella Choleraesuis, Use-Dilution MethodWithdrawn and replaced with newer version172
95AOAC 6.2.02:2005, Official Method 991.47, Testing Disinfectants Against Salmonella Choleraesuis, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version173
96AOAC 6.2.03:2005, Official Method 991.48, Testing Disinfectants Against Staphylococcus Aureus, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version174
97AOAC 6.2.04:2005, Official Method 955.15, Testing Disinfectants Against Staphylococcus Aureus, Use-Dilution MethodWithdrawn and replaced with newer version175
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98AOAC 6.2.05:2005, Official Method 991.49, Testing Disinfectants Against Pseudomonas Aeruginosa, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version176
99AOAC 6.2.06:2005, Official Method 964.02, Testing Disinfectants Against Pseudomonas Aeruginosa, Use-Dilution MethodWithdrawn and replaced with newer version177
100AOAC 6.3.02:2005, Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton MentagrophytesWithdrawn and replaced with newer version178
101AOAC 6.3.05:2005, Official Method 966.04, Sporicidal Activity of DisinfectantsWithdrawn and replaced with newer version179
102AOAC 6.3.06:2005, Official Method 965.12, Tuberculocidal Activity of DisinfectantsWithdrawn and replaced with newer version180
104AAMI/ANSI ST58:2005, Safe Use and Handling of Glutaraldehyde-Based Products in Health Care FacilitiesWithdrawn and replaced with newer version181
116ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch TestingRelevant guidance
117ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical SettingsRelevant guidance
153USP 29:2006, Biological Indicator for Dry Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version182
154USP 29:2006, Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version183
155USP 29:2006, Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version184
156USP29:2006, <61> Microbial Limits TestWithdrawn and replaced with newer version185
157USP 29:2006, <71>, Microbiological Tests, Sterility TestsWithdrawn and replaced with newer version186
158USP29:2006, <85>, Biological Tests and Assays, Bacterial Endotoxin Test (LAL)Withdrawn and replaced with newer version187
159USP29:2006 <151>, Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version188
160USP29:2006 <1211>, Sterilization and Sterility Assurance of Compendial ArticlesWithdrawn
161USP29:2006 <161>, Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version189
162USP 29:2006, Biological Indicator for Steam Sterilization—Self-ContainedWithdrawn and replaced with newer version190
164ANSI/AAMI ST81:2004, Sterilization of Medical Devices—Information to be Provided by the Manufacturer for the Processing of Resterilizable DevicesRelevant 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:Start Printed Page 36125

Table 2.

Item No.Title of StandardReference No. and Date
A. Sterility
191Aseptic Processing of Health Care Products—Part 4: Clean-in-Place TechnologiesISO 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.

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Dated: June 13, 2006.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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

BILLING CODE 4160-01-S