Food and Drug Administration, HHS.
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.
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.
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: firstname.lastname@example.org. 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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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.
|Old Item No.||Standard||Change||Replacement Item No.|
|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|
|Start Printed Page 36123|
|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|
|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|
|Start Printed Page 36124|
|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:Start Printed Page 36125
|Item No.||Title of Standard||Reference No. and Date|
|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.Start Signature
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