This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
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: 021” (Recognition List Number: 021), 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: 021” 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 240-276-3151. 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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. 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: 021 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, 7520 Standish Place, Rockville, MD 20855, 240-276-8714.Start Printed Page 11587End 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.
Modifications to the initial list of recognized standards, as published in the Federal Register, are identified in table 1.
|October 16, 1998 (63 FR 55617)||May 27, 2005 (70 FR 30756)|
|July 12, 1999 (64 FR 37546)||November 8, 2005 (70 FR 67713)|
|November 15, 2000 (65 FR 69022)||March 31, 2006 (71 FR 16313)|
|May 7, 2001 (66 FR 23032)||June 23, 2006 (71 FR 36121)|
|January 14, 2002 (67 FR 1774)||November 3, 2006 (71 FR 64718)|
|October 2, 2002 (67 FR 61893)||May 21, 2007 (72 FR 28500)|
|April 28, 2003 (68 FR 22391)||September 12, 2007 (72 FR 52142)|
|March 8, 2004 (69 FR 10712)||December 19, 2007 (72 FR 71924)|
|June 18, 2004 (69 FR 34176)||September 9, 2008 (73 FR 52358)|
|October 4, 2004 (69 FR 59240)|
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: 021
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: 021” to identify these current modifications.
In table 2 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 Recognition No.||Replacement Recognition No.||Standard||Change|
|1-49||ASTM F 1981-99 Standard Specification for Suction Catheters for use in the Respiratory Tract||Withdrawn|
|1-63||1-77||CGA V-1:2005 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection||Withdrawn and replaced with newer version|
|1-64||1-78||ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human Occupancy||Withdrawn and replaced with newer version|
|Start Printed Page 11588|
|1-71||ISO 10651-5:2006 Lung Ventilators for Medical Use—Particular requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators||Withdrawn duplicate|
|1-74||ISO 5360:2006 Anaesthetic Vaporizers—Agent Specific Filling Systems||Contact person|
|1-76||1-79||ISO 26825:2008 (E) Anaesthetic And Respiratory Equipment—User-Applied Labels For Syringes Containing Drugs Used During Anaesthesia—Colours, Design and Performance||Withdrawn and replaced with newer version|
|2-71||2-133||ASTM F1408-97 (2008) Standard Practice for Subcutaneous Screening Test for Implant Materials||Withdrawn and replaced with newer version|
|2-73||2-134||ASTM F2065-00(2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials||Withdrawn and replaced with newer version|
|2-87||AAMI/ANSI/ISO 10993-10:2002 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type Hypersensitivity||Extent of Recognition, Relevant Guidance, and Contact Person|
|2-88||2-135||AAMI/ANSI/ISO 10993-12:2007 Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference Materials||Withdrawn and replaced with newer version|
|2-127||ANSI/AAMI BE 78:2002/A1:2006 Biological Evaluation of Medical Devices—Part 10: Tests For Irritation and Delayed-Type Hypersensitivity—Amendment 1||Withdrawn|
|3-67||ASTM F2129-06 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices||Offices, Devices Affected, Relevant Guidance, CFR Citation and Product Codes, Contact Person|
|D. General Hospital/General Plastic Surgery|
|6-29||IEC 60601-2-19 1996-10: Amendment 1—Medical Electrical Equipment Part 2: Particular Requirements for Safety of Baby Incubators||Relevant guidance|
|6-32||IEC 60601-2-20 1996-10: Amendment 1—Medical Electrical Equipment Part 2: Particular Requirements for the Safety Of Transport Incubators||Relevant guidance|
|6-62||ISO 8536-6:1995 Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion Bottles||Relevant guidance|
|6-63||ISO 8536-7-1999: Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations For Infusion Bottles||Relevant guidance|
|6-64||ISO 8536-3-1999, Infusion Equipment for Medical Use—Part 3: Aluminum Caps for Infusion Bottles||Relevant guidance|
|6-119||ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood Transfusion Micro-Filters||Reaffirmation 2007, Title, SDO, Date of standard, Relevant guidance|
|6-122||ISO 8536-5-2004:, Infusion Equipment for Medical Use—Part 5: Burette Infusion Sets for Single Use, Gravity Feed||Relevant guidance|
|6-127||ISO 1135-4-2004: Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single Use||Relevant guidance|
|6-142||ANSI/AAMI II36:2004 Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby Incubators||Title, Relevant guidance|
|6-143||ANSI/AAMI II51:2004, Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Transport Incubators||Title, Relevant guidance|
|Start Printed Page 11589|
|6-172||ISO 8536-1:2006 Infusion Equipment for Medical Use—Part 1: Infusion Glass Bottles||Relevant guidance|
|6-173||ISO 8536-2:2001 Corrigendum 1:2003, Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles||Relevant guidance|
|6-182||IEC 60601-2-38 1996/Amendment 1:1999, Medical Electrical Equipment—Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital Beds||Relevant guidance|
|6-201||ISO 8536-4:2007 Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity Feed||Relevant guidance|
|6-215||ASTM F2132-01(2008)E1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps||Title|
|7-138||7-169||CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts||Withdrawn and replaced with newer version|
|7-54||CLSI D12-A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved Guideline||Title|
|7-71||CLSI H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition||Contact person|
|7-145||CLSI H42-A2, Enumeration of Immunologically Defined Cell Populations by Flow Cytometry.||Contact person|
|7-73||7-170||CLSI ILA21-A2 Clinical Evaluation of Immunoassays||Withdrawn and replaced with newer version|
|7-130||CLSI H20-A2, Reference Leucocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition||Contact person|
|7-164||CLSI GP 28-A Microwave Device Use in the Histology Laboratory; Approved Guideline||Contact person|
|7-168||7-171||CLSI M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi||Withdrawn and replaced with newer version|
|3-3||17-1||AAMI NS28:1988/(R) 2006 Intracranial Pressure Monitoring Devices||Transferred, Date of standard, Extent of recognition, Relevant guidance|
|3-32||17-2||ASTM F1542-94(2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips||Transferred, Offices, Type of standard, Extent of recognition, Relevant guidance, Contact person|
|3-33||17-3||ISO 7197:2006 Neurosurgical implants—Sterile, Single-use hydrocephalus Shunts and Components||Transferred—Withdrawn and replaced with newer version|
|3-39||17-4||ASTM F647-94(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application||Transferred—Withdrawn and replaced with newer version|
|3-60||17-5||IEC 60601-2-10 1987/Amendment 1 2001 Medical Electrical Equipment—Part 2-10: Particular Requirements for the Safety of Nerve and Muscle Stimulators||Transferred, Title change, Date of standard, Relevant guidance, Contact person|
|3-67||17-6||ASTM F2129-06 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices||Offices, Devices affected, Type of Standard, Product code, Relevant guidance, Contact person|
|Start Printed Page 11590|
|9-30||9-55||ANSI/ AAMI RD62:2006 Water Treatment Equipment for Hemodialysis Applications||Withdrawn and replaced with newer version|
|9-32||9-56||ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)||Withdrawn and replaced with newer version|
|9-34||ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1||Extent of recognition, Product codes, Relevant guidance|
|12-48||AIUM AOL, Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How Manufacturers Should Specify Acoustic Output Data||Relevant guidance|
|12-55||12-186||IEC 60601-2-29 (2008) Medical Electrical Equipment—Part 2-29: Particular Requirements for the Basic Safety and Essential Performance of Radiotherapy Simulators—Third Edition||Withdrawn and replaced with newer version|
|12-66||AIUM MUS, Medical Ultrasound Safety||Relevant guidance|
|12-96||12-187||NEMA MS 3-2008 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images||Withdrawn and replaced with newer version|
|12-97||12-188||NEMA MS 1-2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging||Withdrawn and replaced with newer version|
|12-100||NEMA UD 3-2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment||Relevant guidance|
|12-105||NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3||Title, Relevant guidance|
|12-139||AIUM AOMS-2005, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment||Relevant guidance|
|12-140||AIUM RTD1-2005, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1||Relevant guidance|
|12-161||12-189||IEC 60601-2-33 (2008) Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis Consolidated Edition 2.2||Withdrawn and replaced with a newer version|
|12-182||IEC 60601-2-37:2007, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment||Relevant guidance|
|12-184||12-190||IEC 61217 (2008) Radiotherapy Equipment—Coordinates, Movements, and Scales Consolidated Edition 1.2||Withdrawn and replaced with newer version|
|14-120||14-257||ASTM D3078—02(2008) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission||Withdrawn and replaced with newer version|
|14-148||14-258||ASTM F2250—03(2008) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials||Withdrawn and replaced with newer version|
|14-149||14-259||ASTM F2251—03(2008) Standard Test Method for Thickness Measurement of Flexible Packaging Material||Withdrawn and replaced with newer version|
|14-150||14-260||ASTM F2252—03(2008) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape||Withdrawn and replaced with newer version|
|J. Tissue Engineering|
|15-11||15-13||ASTM F2212-02(2008)e1, Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products||Withdrawn and replaced with newer version|
III. Listing of New Entries
In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 021.
|Recognition No.||Title of Standard||Reference No. & Date|
|4-160||Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms||ANSI ASA S3.1-1999 (R 2003)|
|4-161||Method for Measuring the Intelligibility of Speech Over Communication Systems||ANSI ASA S3.2-1989 (R 1999)|
|4-162||Procedure for the Computation of Loudness of Steady Sounds||ANSI ASA S3.4-2007|
|4-163||Methods for Calculation of the Speech Intelligibility Index||ANSI ASA S3.5-1997 (R 2007)|
|4-164||Method for Coupler Calibration of Earphones||ANSI ASA S3.7-1995 (R 2003)|
|4-165||Mechanical Coupler for Measurement of Bone Vibrators||ANSI ASA S3.13-1987 (R 2007)|
|4-166||Bioacoustical Terminology||ANSI ASA S3.20-1995 (R 2003)|
|4-167||Methods for Manual Pure-Tone Threshold Audiometry||ANSI ASA S3.21-2004|
|4-168||Occluded Ear Simulator||ANSI ASA S3.25-1989 (R 2003)|
|4-169||Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions||ANSI ASA S3.35-2004|
|4-170||Specification for a Manikin for Simulated in situ Airborne Acoustic Measurements||ANSI ASA S3.36-1985 (R 2006)|
|4-171||Preferred Earhook Nozzle Thread for Postauricular Hearing Aids||ANSI ASA S3.37-1987 (R 2007)|
|4-172||Testing Hearing Aids with a Broad-Band Noise Signal||ANSI ASA S3.42-1992 (R 2007)|
|4-173||Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment||ANSI ASA S3.44-1996 (R 2006)|
|4-174||Procedures for Testing Basic Vestibular Function||ANSI ASA S3.45-1999|
|4-175||Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids||ANSI ASA S3.46-1997 (R 2002)|
|4-176||Criteria for Evaluating Room Noise||ANSI ASA S12.2-1995 (R 1999)|
|4-177||Rating Noise with Respect to Speech Interference||ANSI ASA S12.65-2006|
|5-45||Standard Practice for Performance Testing of Packages for Single Delivery Systems||ASTM D7386-08|
|7-172||Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory||C28-P3|
|7-173||Harmonization of Glycohemoglobin Measurements||C44-A|
|7-174||Estimation of Total Analytical Error for Clinical Laboratory||EP21-A|
|7-175||Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics||ILA15-A|
|7-176||Immunoassay Interference by Endogenous Antibodies||ILA30-A|
|Start Printed Page 11592|
|7-177||Performance Standards for Antimicrobial Susceptibility Testing||M100-S18|
|7-178||Quality Control for Commercially Prepared Microbiological Culture Media||M22-A3|
|7-179||Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts||M27-S3|
|7-180||Western Blot Assay for Antibodies to Borrelia burgdorferi||M34-A|
|7-181||Abbreviated Identification of Bacteria and Yeasts||M35-A|
|7-182||Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii||M36-A|
|7-183||Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi||M38-A2|
|7-184||Quality Control of Microbiological Transport Systems||M40-A|
|7-186||Methods for Antifungal Disk Diffusion Susceptibility Testing||M44-A|
|7-187||Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeast||M44-S2|
|7-188||Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria||M45-A|
|7-189||Principles and Procedures for Blood Cultures||M47-A|
|7-190||Quality Control for Commercial Microbial Identification Systems||M50-A|
|7-191||Collection, Transport, Preparation, and Storage of Specimens||MM13-A|
|7-192||Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing||MM18-A|
|7-193||Evaluation of the Linearity of Quantitative Measurement||EP06-A|
|7-194||Protocols for Determination of Limits of Detection and Limits of Quantitation||EP17-A|
|17-7||Neurosurgical implants—Sterile, Single-use Hydrocephalus Shunts and Components||ISO 7197:2006/Technical Corrigendum1:2007|
|9-57||Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 2||ISO 4074:2002/Cor.2:2008(E)|
|10-58||Laser Systems for Corneal Reshaping||ANSI Z80.11-2007|
|12-191||Ultrasonics—Field Characterization—Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields||IEC 62359:2005|
|13-25||Managing and Validating Laboratory Information Systems; Approved Guideline||CLSI AUTO8-A|
|13-26||Autoverification of Clinical Laboratory Test Results; Approved Guideline||CLSI AUTO10-A|
|13-27||IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard||CLSI AUTO11-A|
|13-28||Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard||CLSI AUTO9-A|
|14-261||Sterilization of Health Care Products—Moist Heat—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices||ANSI/AAMI/ISO 17665-1:2006|
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
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 document announcing “Modification to the List of Recognized Standards, Recognition List Number: 021” 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: 021. These modifications to the list or recognized standards are effective upon publication of this document in the Federal Register.Start Signature
Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-5858 Filed 3-17-09; 8:45 am]
BILLING CODE 4160-01-S