E6-9959. 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: [e-mail]. 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.