| Page Range | 53264-53271 | |
| FR Document | 2018-22977 |
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)] [Notices] [Pages 53264-53271] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22977] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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: 050'' (Recognition List Number: 050), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective October 22, 2018. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' 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: 050.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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: 050. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of Recognition List Number: 050 is available on the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 050 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: 050'' to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287. Send one self- addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144. FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 [[Page 53265]] premarket review submissions or other requirements. In the Federal Register notice of September 13, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled ``Appropriate use of Voluntary Consensus Standards in Premarket Submission for Medical Devices.'' The guidance describes how FDA has implemented its standard recognition program and is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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. Additional information on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm. II. Modifications to the List of Recognized Standards, Recognition List Number: 050 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term ``Recognition List Number: 050'' to identify the current modifications. In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (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, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. Table 1--Modifications to the List of Recognized Standards ------------------------------------------------------------------------ Replacement Old recognition recognition Title of standard Change \2\ No. No. \1\ ------------------------------------------------------------------------ A. Anesthesiology ------------------------------------------------------------------------ 1-85.............. 1-139 ISO 80601-2-61 Withdrawn and Second edition replaced with 2017-12 newer version. (Corrected version 2018-02) Medical electrical equipment--Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. 1-96.............. 1-140 ISO 80601-2-55 Withdrawn and Second edition replaced with 2018-02 Medical newer version. electrical equipment--Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors. ------------------------------------------------------------------------ B. Biocompatibility ------------------------------------------------------------------------ 2-176............. 2-255 ISO 10993-11 Withdrawn and Third edition replaced with 2017-09 newer version. Biological evaluation of medical devices-- Part 11: Tests for systemic toxicity. 2-204............. 2-256 ASTM F720-17 Withdrawn and Standard replaced with Practice for newer version. Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test. 2-233............. 2-257 ASTM F2382-17e1 Withdrawn and Standard Test replaced with Method for newer version. Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT). ------------------------------------------------------------------------ C. Cardiovascular ------------------------------------------------------------------------ 3-110............. .............. AAMI TIR41:2011/ Reaffirmation. (R)2017 Technical Information Report Active implantable medical devices-- Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators. 3-123............. 3-152 IEC 80601-2-30 Withdrawn and Edition 1.1 2013- replaced with 07 Medical newer version. electrical equipment--Part 2-30: Particular requirements for the basic safety and essential performance of automated non- invasive sphygmomanometer s. ------------------------------------------------------------------------ D. Dental/Ear, Nose, and Throat (ENT) ------------------------------------------------------------------------ 4-214............. 4-242 ISO 10139-1 Third Withdrawn and edition 2018-03 replaced with Dentistry--Soft newer version. lining materials for removable dentures--Part 1: Materials for short-term use. ------------------------------------------------------------------------ E. General I (Quality Systems/Risk Management) (QS/RM) ------------------------------------------------------------------------ 5-42.............. .............. ASTM D903-98 Reaffirmation. (Reapproved 2017) Standard Test Method for Peel or Stripping Strength of Adhesive Bonds. ------------------------------------------------------------------------ F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ------------------------------------------------------------------------ 19-8.............. .............. IEC 60601-1-2 Extent of Edition 4.0 2014- recognition. 02 Medical electrical equipment--Part 1-2: General requirements for basic safety and essential performance--Col lateral Standard: Electromagnetic disturbances--Re quirements and tests. 19-19............. .............. IEC TR 60601-4-2 Extent of Edition 1.0 2016- recognition. 05 Medical electrical equipment--Part 4-2: Guidance and interpretation-- Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. [[Page 53266]] 19-21............. 19-30 AIM Standard Withdrawn and 7351731 Rev. replaced with 2.00 Medical newer version. Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers--An AIM Standard. ------------------------------------------------------------------------ G. General Hospital/General Plastic Surgery (GH/GPS) ------------------------------------------------------------------------ 6-123............. .............. ASTM E667-98 Reaffirmation. (Reapproved 2017) Standard Specification for Mercury[hyphen]i n[hyphen]Glass, Maximum Self[hyphen]Regi stering Clinical Thermometers. 6-254............. .............. ASTM F2100-11 Reaffirmation. (Reapproved 2018) Standard Specification for Performance of Materials Used in Medical Face Masks. 6-301............. 6-408 ISO 10555-1 Withdrawn and Second edition replaced with 2013-06-15 newer version Intravascular including catheters--Steri amendment. le and single- use catheters-- Part 1: General requirements [Including AMENDMENT 1 (2017)]. 6-352............. 6-409 ASTM F703-18 Withdrawn and Standard replaced with Specification newer version. for Implantable Breast Prostheses. ------------------------------------------------------------------------ H. In Vitro Diagnostics (IVD) ------------------------------------------------------------------------ 7-127............. 7-275 CLSI EP07 3rd Withdrawn and Edition replaced with Interference newer version. Testing in Clinical Chemistry. 7-171............. 7-276 CLSI M38 3rd Withdrawn and Edition replaced with Reference Method newer version. for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi. 7-201............. 7-277 CLSI GP41 7th Withdrawn and Edition replaced with Collection of newer version. Diagnostic Venous Blood Specimens. 7-204............. 7-278 CLSI M27 4th Withdrawn and Edition replaced with Reference Method newer version. for Broth Dilution Antifungal Susceptibility Testing of Yeasts. 7-217............. .............. CLSI M60 1st Title change. Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts. 7-240............. .............. CLSI M27-S4 Withdrawn. See 7- Reference Method 217. for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement. 7-245............. .............. CLSI EP09-A3 Withdrawn. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline--Third Edition. 7-254............. 7-279 CLSI M07 11th Withdrawn and Edition Methods replaced with for Dilution newer version. Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. 7-258............. 7-280 CLSI M02 13th Withdrawn and Edition replaced with Performance newer version. Standards for Antimicrobial Disk Susceptibility Tests. 7-271............. 7-281 CLSI M100 28th Withdrawn and Edition replaced with Performance newer version. Standards for Antimicrobial Susceptibility Testing. ------------------------------------------------------------------------ I. Materials ------------------------------------------------------------------------ 8-57.............. 8-465 ISO 5832-2 Fourth Withdrawn and edition 2018-03 replaced with Implants for newer version. surgery--Metalli c materials-- Part 2: Unalloyed titanium. 8-112............. .............. ASTM F1044-05 Reaffirmation. (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings. 8-128............. 8-466 ASTM F2213-17 Withdrawn and Standard Test replaced with Method for newer version. Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. 8-330............. 8-467 ASTM F1978-18 Withdrawn and Standard Test replaced with Method for newer version. Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser. 8-334............. 8-468 ASTM F2459-18 Withdrawn and Standard Test replaced with Method for newer version. Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. 8-372............. 8-469 ASTM F560-17 Withdrawn and Standard replaced with Specification newer version. for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400). 8-380............. .............. ASTM F1160-14 Reaffirmation. (Reapproved 2017)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/ Metallic Coatings. 8-382............. 8-470 ASTM F2102-17 Withdrawn and Standard Guide replaced with for Evaluating newer version. the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants. 8-390............. 8-471 ASTM F1925-17 Withdrawn and Standard replaced with Specification newer version. for Semi- Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants. 8-412............. .............. ASTM F2537-06 Reaffirmation. (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion. 8-414............. 8-472 ASTM F2847-17 Withdrawn and Standard replaced with Practice for newer version. Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments. 8-419............. 8-473 ASTM F2885-17 Withdrawn and Standard replaced with Specification newer version. for Metal Extent of Injection Molded recognition. Titanium- 6Aluminum- 4Vanadium Components for Surgical Implant Applications. 8-420............. 8-474 ASTM F2886-17 Withdrawn and Standard replaced with Specification newer version. for Metal Injection Molded Cobalt- 28Chromium- 6Molybdenum Components for Surgical Implant Applications. [[Page 53267]] 8-436............. 8-475 ASTM F2026-17 Withdrawn and Standard replaced with Specification newer version. for Polyetheretherke tone (PEEK) Polymers for Surgical Implant Applications. 8-448............. 8-476 ASTM F2004-17 Withdrawn and Standard Test replaced with Method for newer version. Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis. 8-454............. 8-477 ASTM F2129-17b Withdrawn and Standard Test replaced with Method for newer version. Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. ------------------------------------------------------------------------ J. Nanotechnology No new entries at this time. ------------------------------------------------------------------------ K. Neurology No new entries at this time. ------------------------------------------------------------------------ L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) ------------------------------------------------------------------------ 9-43.............. 9-117 ISO 16038 Second Withdrawn and edition 2017-11 replaced with Male condoms-- newer version. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms. 9-67.............. .............. ASTM D7661-10 Reaffirmation. (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. 9-92.............. 9-118 ISO 8637-1 First Withdrawn and edition 2017-11 replaced with Extracorporeal newer version. systems for blood purification--Pa rt 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrato rs. 9-95.............. 9-119 IEC 60601-2-36 Withdrawn and Edition 2.0 2014- replaced with 04 Medical new recognition electrical number. equipment--Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy. 9-112............. 9-120 ASTM D3492-16 Withdrawn and Standard replaced with Specification newer version. for Rubber Contraceptives (Male Condoms). ------------------------------------------------------------------------ M. Ophthalmic ------------------------------------------------------------------------ 10-56............. .............. ANSI Z80.12-2007 Reaffirmation. (R2017) American National Standard for Ophthalmics--Mul tifocal Intraocular Lenses. 10-57............. .............. ANSI Z80.13-2007 Reaffirmation. (R2017) American National Standard for Ophthalmics--Pha kic Intraocular Lenses. 10-60............. 10-111 ISO 11981 Third Withdrawn and edition 2017-11 replaced with Ophthalmic newer version. optics--Contact lenses and contact lens care products-- Determination of physical compatibility of contact lens care products with contact lenses. 10-67............. 10-112 ISO 11986 Third Withdrawn and edition 2017-11 replaced with Ophthalmic newer version. optics--Contact lenses and contact lens care products-- Determination of preservative uptake and release. 10-84............. .............. ANSI Z80.11-2012 Reaffirmation. (R2017) American National Standard for Ophthalmics--Las er Systems for Corneal Reshaping. ------------------------------------------------------------------------ N. Orthopedic ------------------------------------------------------------------------ 11-185............ .............. ASTM F2267-04 Reaffirmation. (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. 11-197............ .............. ASTM F983-86 Reaffirmation. (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components. 11-199............ .............. ASTM F565-04 Reaffirmation. (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments. 11-203............ 11-322 ASTM F1541-17 Withdrawn and Standard replaced with Specification newer version. and Test Methods for External Skeletal Fixation Devices. 11-224............ 11-323 ASTM F2706-17 Withdrawn and Standard Test replaced with Methods for newer version. Occipital- Cervical and Occipital- Cervical- Thoracic Spinal Implant Constructs in a Vertebrectomy Model. 11-226............ 8-478 ASTM F1089-18 Withdrawn and Standard Test replaced with Method for newer version. Corrosion of Transferred. Surgical Instruments. 11-227............ 11-324 ASTM F366-17 Withdrawn and Standard replaced with Specification newer version. for Fixation Pins and Wires. 11-228............ 11-325 ASTM F564-17 Withdrawn and Standard replaced with Specification newer version. and Test Methods for Metallic Bone Staples. 11-245............ 11-326 ASTM F384-17 Withdrawn and Standard replaced with Specifications newer version. and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. 11-257............ 11-327 ASTM F543-17 Withdrawn and Standard replaced with Specification newer version. and Test Methods for Metallic Medical Bone Screws. 11-261............ 11-328 ASTM F1378-17 Withdrawn and Standard replaced with Specification newer version. for Shoulder Prostheses. [[Page 53268]] 11-271............ 11-329 ASTM F2180-17 Withdrawn and Standard replaced with Specification newer version. for Metallic Implantable Strands and Cables. 11-284............ 11-330 ASTM F2028-17 Withdrawn and Standard Test replaced with Methods for newer version. Dynamic Evaluation of Glenoid Loosening or Disassociation. 11-288............ 11-331 ASTM F2077-17 Withdrawn and Test Methods for replaced with Intervertebral newer version. Body Fusion Devices. 11-296............ 11-332 ASTM F2193-18 Withdrawn and Standard replaced with Specification newer version. and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System. 11-297............ 11-333 ASTM F382-17 Withdrawn and Standard replaced with Specification newer version. and Test Method for Metallic Bone Plates. 11-310............ .............. ASTM F1611-00 Reaffirmation. (Reapproved 2018) Standard Specification for Intramedullary Reamers. 11-315............ 11-334 ASTM F1829-17 Withdrawn and Standard Test replaced with Method for newer version. Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear. 11-318............ 11-335 ASTM F3141-17a Withdrawn and Standard Guide replaced with for Total Knee newer version. Replacement Loading Profiles. ------------------------------------------------------------------------ O. Physical Medicine ------------------------------------------------------------------------ 16-159............ 16-202 ISO 7176-2 Third Withdrawn and edition 2017-10 replaced with Wheelchairs--Par newer version. t 2: Determination of dynamic stability of electric wheelchairs. 16-185............ .............. ANSI RESNA WC- Extent of 2:2009 American recognition. National Standard for Wheelchairs--Vol ume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters. 16-193............ 16-203 ASME A18.1-2017 Withdrawn and Safety Standard replaced with for Platform newer version. Lifts and Stairway Chairlifts. ------------------------------------------------------------------------ P. Radiology ------------------------------------------------------------------------ 12-202............ .............. IEC 60601-2-43 Recognition Edition 2.0 2010- restored with 03 Medical transition electrical period. equipment--Part 2-43: Particular requirements for the safety and essential performance of X- ray equipment for interventional procedures. 12-204............ .............. IEC 60601-2-28 Recognition Edition 2.0 2010- restored with 03 Medical transition electrical period. equipment--Part 2-28: Particular requirements for the basic safety and essential performance of X- ray tube assemblies for medical diagnosis. 12-296............ 12-317 IEC 60601-2-54 Withdrawn and CONSOLIDATED replaced with VERSION Edition newer version 1.1 2015-04 including Medical amendment. electrical equipment--Part 2-54: Particular requirements for the basic safety and essential performance of X- ray equipment for radiography and radioscopy [Including: Amendment 2 (2018)]. ------------------------------------------------------------------------ Q. Software/Informatics ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ R. Sterility ------------------------------------------------------------------------ 14-138............ 14-512 ISO 13408-2 Withdrawn and Second edition replaced with 2018-01 Aseptic newer version. processing of health care products--Part 2: Sterilizing filtration. 14-275............ .............. ANSI/AAMI Reaffirmation. ST41:2008/ (R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness. 14-293............ .............. ANSI/AAMI Reaffirmation. ST50:2004/ (R)2018 Dry heat (heated air) sterilizers. 14-294............ .............. ANSI/AAMI Reaffirmation. ST40:2004/ (R)2018 Table- top dry heat (heated air) sterilization and sterility assurance in health care facilities. 14-295............ .............. ANSI/AAMI Withdrawn. See 14- ST81:2004/ 515. (R)2016 Sterilization of medical devices-- Information to be provided by the manufacturer for the processing of resterilizable medical devices. 14-344............ 14-513 ASTM F2825-18 Withdrawn and Standard replaced with Practice for newer version. Climatic Stressing of Packaging Systems for Single Parcel Delivery. 14-407............ 14-514 ISO 11737-1 Third Withdrawn and edition 2018-01 replaced with Sterilization of newer version. health care products--Microb iological methods--Part 1: Determination of a population of microorganisms on products. ------------------------------------------------------------------------ S. Tissue Engineering ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. \2\ Standards that are ``Withdrawn'' or ``Withdrawn and replaced with newer version'' will have a transition period with an expiration date as noted in the recognition database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. [[Page 53269]] III. Listing of New Entries 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: 050. Table 2--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. and Recognition No. Title of standard \1\ date ------------------------------------------------------------------------ A. Anesthesiology ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ B. Biocompatibility ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ C. Cardiovascular ------------------------------------------------------------------------ 3-153................. Standard Guide for Coating ASTM F2743-11. Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems. 3-154................. Standard Guide for Fatigue- ASTM F3211-17. to-Fracture (FtF) Methodology for Cardiovascular Medical Devices. 3-155................. Medical electrical IEC 60601-2-47 equipment--Part 2-47: Edition 2.0 2012- Particular requirements 02. for the basic safety and essential performance of ambulatory electrocardiographic systems. 3-156................. Implants for surgery-- ISO 14708-1 Second Active implantable edition 2014-08-15. medical devices--Part 1: General requirements for safety, marking and for information to be provided by the manufacturer. ------------------------------------------------------------------------ D. Dental/Ear, Nose, and Throat (ENT) ------------------------------------------------------------------------ 4-243................. Corrosion Test Methods.... ANSI/ADA Standard No. 97:2002/ISO 10271:2001 Reaffirmed by ANSI: May 29, 2013. 4-244................. Dentistry--Test methods ISO 8325 Second for rotary instruments. edition 2004-09-15. 4-245................. Dentistry--Corrosion test ISO 10271 Second methods for metallic edition 2011-08-01. materials. 4-246................. Dentistry--Pre-capsulated ISO 20749 First dental amalgam. edition 2017-03. 4-247................. Dentistry--Laser welding ISO 28319 Second and filler materials. edition 2018-04. ------------------------------------------------------------------------ E. General I (Quality Systems/Risk Management) (QS/RM) ------------------------------------------------------------------------ 5-118................. Guidance for the creation AAMI TIR66:2017. of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms. 5-119................. Medical devices-- ISO 18250-3 First Connectors for reservoir edition 2018-06. delivery systems for healthcare applications-- Part 3: Enteral application. ------------------------------------------------------------------------ F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ------------------------------------------------------------------------ 19-31................. American National Standard ANSI C63.15-2017 Recommended Practice for (Revision of ANSI the Immunity Measurement C63.15-2016). of Electrical and Electronic Equipment. ------------------------------------------------------------------------ G. General Hospital/General Plastic Surgery (GH/GPS) ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ H. In Vitro Diagnostics (IVD) ------------------------------------------------------------------------ 7-282................. Performance Standards for CLSI M60 1st Antifungal Susceptibility Edition. Testing of Yeasts. 7-283................. Essential Tools for CLSI POCT04 3rd Implementation and Edition. Management of a Point-of- Care Testing Program. 7-284................. Supplemental Tables for CLSI EP37 1st Interference Testing in Edition. Clinical Chemistry. ------------------------------------------------------------------------ I. Materials ------------------------------------------------------------------------ 8-479................. Implants for surgery-- ISO 13781 Second Homopolymers, copolymers edition 2017-07. and blends on poly(lactide)--In vitro degradation testing. ------------------------------------------------------------------------ [[Page 53270]] J. Nanotechnology ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ K. Neurology ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ M. Ophthalmic ------------------------------------------------------------------------ 10-113................ American National Standard ANSI Z80.30-2018. for Ophthalmics--Toric Intraocular Lenses. ------------------------------------------------------------------------ N. Orthopedic ------------------------------------------------------------------------ 11-336................ Wear of implant materials-- ISO 17853 Third Polymer and metal wear edition 2011-03-01. articles--Isolation and characterization. 11-337................ Implants for surgery-- ISO 16087 First Roentgen edition 2013-10-01. stereophotogrammetric analysis for the assessment of migration of orthopaedic implants. 11-338................ Implants for surgery-- ISO 11491 First Determination of impact edition 2017-07. resistance of ceramic femoral heads for hip joint prostheses. 11-339................ Implants for surgery-- ISO 7206-2 Third Partial and total hip edition 2011-04-01 joint prostheses--Part 2: AMENDMENT 1 2016-09- Articulating surfaces 15. made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016)]. 11-340................ Standard Guide for ASTM F3018-17. Assessment of Hard-on- Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices. 11-341................ Standard Test Method for ASTM F3140-17. Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements. ------------------------------------------------------------------------ O. Physical Medicine ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ P. Radiology ------------------------------------------------------------------------ 12-318................ Medical electrical IEC 60601-2-64 equipment--Part 2-64: Edition 1.0 2014- Particular requirements 09. for the basic safety and essential performance of light ion beam medical electrical equipment. 12-319................ Medical electrical IEC 60601-2-68 equipment--Part 2-68: Edition 1.0 2014- Particular requirements 09. for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment. 12-320................ Medical electrical IEC 62667 Edition equipment--Medical light 1.0 2017-08. ion beam equipment-- Performance characteristics. ------------------------------------------------------------------------ Q. Software/Informatics ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ R. Sterility ------------------------------------------------------------------------ 14-515................ Processing of health care ISO 17664 Second products--Information to edition 2017-10. be provided by the medical device manufacturer for the processing of medical devices. 14-516................ Standard Test Method for ASTM F3039-15. Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration. 14-517................ Standard Guide for ASTM F3293-18. Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices. ------------------------------------------------------------------------ S. Tissue Engineering ------------------------------------------------------------------------ 15-55................. Standard Guide for Micro- ASTM F3259-17. computed Tomography of Tissue Engineered Scaffolds. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet [[Page 53271]] appeared in the Federal Register). FDA will announce additional modifications and 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 FD&C Act by submitting such recommendations, with reasons for the recommendation, to [email protected]. To be considered, such recommendations should contain, at a minimum, the following information available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm. Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22977 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective October 22, 2018. | |
| Contact | Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected] | |
| FR Citation | 83 FR 53264 |