Source: https://www.federalregister.gov/documents/2016/09/21/2016-22710/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized
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Federal Register :: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045
Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective September 21, 2016.
64917-64920 (4 pages)
II. Modifications to the List of Recognized Standards, Recognition List Number: 045
https://www.federalregister.gov/d/2016-22710 https://www.federalregister.gov/d/2016-22710
The Food and Drug Administration (FDA or Agency) 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: 045” (Recognition List Number: 045), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact Start Printed Page 64918information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
Instructions: All submissions received must include the Docket No. FDA-2004-N-0451 for “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. 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: 045.
An electronic copy of Recognition List Number: 045 is available on the Internet at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm. 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: 045 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 045” to Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149.
In a document 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 document described how FDA would implement its standard recognition program and provided the initial list of recognized standards.
These documents 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.
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions 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: 045” to identify these current modifications.
In section III, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.Start Printed Page 64919
A. General I (Quality Systems/Risk Management) (QS/RM)
5-85 IEC 60601-1-6 Edition 3.0 2010-01 Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability Withdrawn. See Rec# 5-89.
5-86 IEC 60601-1-8 Edition 2.0 2006-10 Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Withdrawn. See Rec# 5-76.
5-106 5-109 ISO 80369-3 First edition 2016-07-01 Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications Withdrawn and replaced with newer version.
B. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19-3 IEC 60601-1-10 Edition 1.0 2007-11 Medical electrical equipment—Part 1-10: General requirements for basic safety and essential performance—Collateral standard: Requirements for the development of physiologic closed-loop controllers Withdrawn. See Rec# 19-9.
19-5 AAMI/ANSI ES60601-1:2005/(R) 2012 and C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated text) Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) Withdrawn. See Rec# 19-4.
C. General Hospital/General Plastic Surgery (GH/GPS)
6-362 6-379 ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use—Requirements and test methods Withdrawn and replaced with newer version.
6-366 6-380 ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices—Requirements and test methods Withdrawn and replaced with newer version.
6-376 6-381 ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use—Colour coding for identification Withdrawn and replaced with a newer version.
6-378 6-382 ISO 11608-7 First edition 2016-08-01 Needle-based injection systems for medical use—Requirements and test methods—Part 7: Accessibility for persons with visual impairment Withdrawn and replaced with a newer version.
D. Obstetrics-Gynecology (OB-GYN)/Gastroenterology/Urology
9-61 IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment Combined with 4-187.
10-51 ISO 15004-2 First edition 2007-02-15 Ophthalmic Instruments—Fundamental requirements and test methods—Part 2: Light hazard protection Transition period.
12-208 IEC 60601-2-22 Third Edition 2007-05 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Withdrawn. See Rec# 12-268.
12-210 IEC 60601-1-3 Edition 2.0 2008-01 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral standard: Radiation protection in diagnostic x-ray equipment Withdrawn. See Rec# 12-269.
1 All standard titles in this table conform to the style requirements of the respective organizations
In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 045.
5-110 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less ISTA 3A 2008.
5-111 Packaged-Products for Less-Than-Truckload (LTL) Shipment ISTA 3B 2012.
5-112 Unitized Loads of Same Product ISTA 3E 2009.
B. In Vitro Diagnostics (IVD)
7-265 Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline C62-A: 2014.
7-266 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures EP19 Second Edition: 2015.
10-101 Ophthalmic optics—Contact lenses and contact lens care products—Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions ISO 18189 First edition 2016-06-01.
10-102 American National Standard for Ophthalmics—Light Hazard Protection for Ophthalmic Instruments ANSI Z80.36—2016.
You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. The Center for Devices and Radiological Health (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, http://www.fda.gov/​MedicalDevices, includes a link to standards-related documents including the guidance and the current list of recognized standards. After publication in the Federal Register, this notice announcing “Modification to the List of Recognized Standards, Recognition List Number: 045” will be available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm. You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards.
[FR Doc. 2016-22710 Filed 9-20-16; 8:45 am]