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Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050, 53264-53271 [2018-22977] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050, 53264-53271 [2018-22977]
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050, 53264-53271 [2018-22977]
Download as PDF 53264 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices the information package in accordance with the guidance. Dated: October 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–22954 Filed 10–19–18; 8:45 am] BILLING CODE 4164–01–P 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. 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: SUMMARY: daltland on DSKBBV9HB2PROD with NOTICES 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 VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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, CDRHStandardsStaff@fda.hhs.gov. 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 E:\FR\FM\22OCN1.SGM 22OCN1 53265 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 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/Medical Devices/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/DeviceRegulationand Guidance/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 Old recognition No. Replacement recognition No. Title of standard 1 Change 2 A. Anesthesiology 1–85 .............. 1–139 1–96 .............. 1–140 ISO 80601–2–61 Second edition 2017–12 (Corrected version 2018–02) Medical electrical equipment—Part 2–61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. ISO 80601–2–55 Second edition 2018–02 Medical electrical equipment—Part 2–55: Particular requirements for the basic safety and essential performance of respiratory gas monitors. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. B. Biocompatibility 2–176 ............ 2–255 2–204 ............ 2–256 2–233 ............ 2–257 ISO 10993–11 Third edition 2017–09 Biological evaluation of medical devices— Part 11: Tests for systemic toxicity. ASTM F720–17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test. ASTM F2382–17e1 Standard Test Method for Assessment of Circulating BloodContacting Medical Device Materials on Partial Thromboplastin Time (PTT). Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. C. Cardiovascular 3–110 ............ ........................ 3–123 ............ 3–152 AAMI TIR41:2011/(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. IEC 80601–2–30 Edition 1.1 2013–07 Medical electrical equipment—Part 2–30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. Reaffirmation. Withdrawn and replaced with newer version. D. Dental/Ear, Nose, and Throat (ENT) 4–214 ............ 4–242 ISO 10139–1 Third edition 2018–03 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use. Withdrawn and replaced with newer version. E. General I (Quality Systems/Risk Management) (QS/RM) daltland on DSKBBV9HB2PROD with NOTICES 5–42 .............. ........................ ASTM D903–98 (Reapproved 2017) Standard Test Method for Peel or Stripping Strength of Adhesive Bonds. Reaffirmation. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19–8 .............. ........................ 19–19 ............ ........................ VerDate Sep<11>2014 18:12 Oct 19, 2018 IEC 60601–1–2 Edition 4.0 2014–02 Medical electrical equipment—Part 1–2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests. IEC TR 60601–4–2 Edition 1.0 2016–05 Medical electrical equipment—Part 4– 2: Guidance and interpretation—Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. Jkt 247001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1 Extent of recognition. Extent of recognition. 53266 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. 19–21 ............ Replacement recognition No. 19–30 Title of standard 1 Change 2 AIM Standard 7351731 Rev. 2.00 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers—An AIM Standard. Withdrawn and replaced with newer version. G. General Hospital/General Plastic Surgery (GH/GPS) 6–123 ............ ........................ 6–254 ............ ........................ 6–301 ............ 6–408 6–352 ............ 6–409 ASTM E667–98 (Reapproved 2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers. ASTM F2100–11 (Reapproved 2018) Standard Specification for Performance of Materials Used in Medical Face Masks. ISO 10555–1 Second edition 2013–06–15 Intravascular catheters—Sterile and single-use catheters—Part 1: General requirements [Including AMENDMENT 1 (2017)]. ASTM F703–18 Standard Specification for Implantable Breast Prostheses ......... Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version including amendment. Withdrawn and replaced with newer version. H. In Vitro Diagnostics (IVD) 7–127 ............ 7–275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry ....................... 7–171 ............ 7–276 7–201 ............ 7–277 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi. CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens ......... 7–204 ............ 7–278 7–217 ............ ........................ 7–240 ............ ........................ 7–245 ............ ........................ 7–254 ............ 7–279 7–258 ............ 7–280 7–271 ............ 7–281 CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts. CLSI M27–S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement. CLSI EP09–A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition. CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests. CLSI M100 28th Edition Performance Standards for Antimicrobial Susceptibility Testing. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Title change. Withdrawn. See 7–217. Withdrawn. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. daltland on DSKBBV9HB2PROD with NOTICES I. Materials 8–57 .............. 8–465 8–112 ............ ........................ 8–128 ............ 8–466 8–330 ............ 8–467 8–334 ............ 8–468 8–372 ............ 8–469 8–380 ............ ........................ 8–382 ............ 8–470 8–390 ............ 8–471 8–412 ............ ........................ 8–414 ............ 8–472 8–419 ............ 8–473 8–420 ............ 8–474 VerDate Sep<11>2014 18:12 Oct 19, 2018 ISO 5832–2 Fourth edition 2018–03 Implants for surgery—Metallic materials— Part 2: Unalloyed titanium. ASTM F1044–05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings. ASTM F2213–17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. ASTM F1978–18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser. ASTM F2459–18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. ASTM F560–17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400). ASTM F1160–14 (Reapproved 2017)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings. ASTM F2102–17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants. ASTM F1925–17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants. ASTM F2537–06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion. ASTM F2847–17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments. ASTM F2885–17 Standard Specification for Metal Injection Molded Titanium6Aluminum-4Vanadium Components for Surgical Implant Applications. ASTM F2886–17 Standard Specification for Metal Injection Molded Cobalt28Chromium-6Molybdenum Components for Surgical Implant Applications. Jkt 247001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1 Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Extent of recognition. Withdrawn and replaced with newer version. 53267 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 8–436 ............ 8–475 8–448 ............ 8–476 8–454 ............ 8–477 Title of standard 1 Change 2 ASTM F2026–17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. ASTM F2004–17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis. ASTM F2129–17b Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. 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 9–67 .............. ........................ 9–92 .............. 9–118 9–95 .............. 9–119 9–112 ............ 9–120 ISO 16038 Second edition 2017–11 Male condoms—Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms. ASTM D7661–10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. ISO 8637–1 First edition 2017–11 Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. IEC 60601–2–36 Edition 2.0 2014–04 Medical electrical equipment—Part 2–36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy. ASTM D3492–16 Standard Specification for Rubber Contraceptives (Male Condoms). Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with new recognition number. Withdrawn and replaced with newer version. M. Ophthalmic 10–56 ............ ........................ 10–57 ............ ........................ 10–60 ............ 10–111 10–67 ............ 10–112 10–84 ............ ........................ ANSI Z80.12–2007 (R2017) American National Standard for Ophthalmics— Multifocal Intraocular Lenses. ANSI Z80.13–2007 (R2017) American National Standard for Ophthalmics— Phakic Intraocular Lenses. ISO 11981 Third edition 2017–11 Ophthalmic optics—Contact lenses and contact lens care products—Determination of physical compatibility of contact lens care products with contact lenses. ISO 11986 Third edition 2017–11 Ophthalmic optics—Contact lenses and contact lens care products—Determination of preservative uptake and release. ANSI Z80.11–2012 (R2017) American National Standard for Ophthalmics— Laser Systems for Corneal Reshaping. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. daltland on DSKBBV9HB2PROD with NOTICES N. Orthopedic 11–185 .......... ........................ 11–197 .......... ........................ 11–199 .......... ........................ 11–203 .......... 11–322 11–224 .......... 11–323 11–226 .......... 8–478 ASTM F2267–04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. ASTM F983–86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components. ASTM F565–04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments. ASTM F1541–17 Standard Specification and Test Methods for External Skeletal Fixation Devices. ASTM F2706–17 Standard Test Methods for Occipital-Cervical and OccipitalCervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model. ASTM F1089–18 Standard Test Method for Corrosion of Surgical Instruments .. 11–227 .......... 11–324 ASTM F366–17 Standard Specification for Fixation Pins and Wires .................... 11–228 .......... 11–325 11–245 .......... 11–326 11–257 .......... 11–327 11–261 .......... 11–328 ASTM F564–17 Standard Specification and Test Methods for Metallic Bone Staples. ASTM F384–17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. ASTM F543–17 Standard Specification and Test Methods for Metallic Medical Bone Screws. ASTM F1378–17 Standard Specification for Shoulder Prostheses ...................... VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1 Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Transferred. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. 53268 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 11–271 .......... 11–329 11–284 .......... 11–330 11–288 .......... 11–331 11–296 .......... 11–332 11–297 .......... 11–333 11–310 .......... ........................ 11–315 .......... 11–334 11–318 .......... 11–335 Title of standard 1 Change 2 ASTM F2180–17 Standard Specification for Metallic Implantable Strands and Cables. ASTM F2028–17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation. ASTM F2077–17 Test Methods for Intervertebral Body Fusion Devices .............. ASTM F2193–18 Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System. ASTM F382–17 Standard Specification and Test Method for Metallic Bone Plates. ASTM F1611–00 (Reapproved 2018) Standard Specification for Intramedullary Reamers. ASTM F1829–17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear. ASTM F3141–17a Standard Guide for Total Knee Replacement Loading Profiles. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. O. Physical Medicine 16–159 .......... 16–202 16–185 .......... ........................ 16–193 .......... 16–203 ISO 7176–2 Third edition 2017–10 Wheelchairs—Part 2: Determination of dynamic stability of electric wheelchairs. ANSI RESNA WC–2:2009 American National Standard for Wheelchairs—Volume 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. ASME A18.1–2017 Safety Standard for Platform Lifts and Stairway Chairlifts .... Withdrawn and replaced with newer version. Extent of recognition. Withdrawn and replaced with newer version. P. Radiology 12–202 .......... ........................ 12–204 .......... ........................ 12–296 .......... 12–317 IEC 60601–2–43 Edition 2.0 2010–03 Medical electrical equipment—Part 2–43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures. IEC 60601–2–28 Edition 2.0 2010–03 Medical electrical equipment—Part 2–28: Particular requirements for the basic safety and essential performance of Xray tube assemblies for medical diagnosis. IEC 60601–2–54 CONSOLIDATED VERSION Edition 1.1 2015–04 Medical 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)]. Recognition restored with transition period. Recognition restored with transition period. Withdrawn and replaced with newer version including amendment. Q. Software/Informatics No new entries at this time. daltland on DSKBBV9HB2PROD with NOTICES R. Sterility 14–138 .......... 14–512 14–275 .......... ........................ 14–293 .......... 14–294 .......... ........................ ........................ 14–295 .......... ........................ 14–344 .......... 14–513 14–407 .......... 14–514 ISO 13408–2 Second edition 2018–01 Aseptic processing of health care products—Part 2: Sterilizing filtration. ANSI/AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness. ANSI/AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers ......................... ANSI/AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities. ANSI/AAMI ST81:2004/(R)2016 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices. ASTM F2825–18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery. ISO 11737–1 Third edition 2018–01 Sterilization of health care products— Microbiological methods—Part 1: Determination of a population of microorganisms on products. Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn. See 14–515. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. 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. 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. 2 Standards VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices III. Listing of New Entries In table 2, FDA provides the listing of new entries and consensus standards 53269 added as modifications to the list of recognized standards under Recognition List Number: 050. TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Recognition No. Title of standard 1 Reference No. and date A. Anesthesiology No new entries at this time. B. Biocompatibility No new entries at this time. C. Cardiovascular 3–153 ........... 3–154 ........... 3–155 ........... 3–156 ........... Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems. Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices. Medical electrical equipment—Part 2–47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer. ASTM F2743–11. ASTM F3211–17. IEC 60601–2–47 Edition 2.0 2012–02. ISO 14708–1 Second edition 2014–08– 15. D. Dental/Ear, Nose, and Throat (ENT) 4–243 ........... Corrosion Test Methods ................................................................................................ 4–244 4–245 4–246 4–247 Dentistry—Test methods for rotary instruments ........................................................... Dentistry—Corrosion test methods for metallic materials ............................................ Dentistry—Pre-capsulated dental amalgam ................................................................. Dentistry—Laser welding and filler materials ............................................................... ........... ........... ........... ........... ANSI/ADA Standard No. 97:2002/ISO 10271:2001 Reaffirmed by ANSI: May 29, 2013. ISO 8325 Second edition 2004–09–15. ISO 10271 Second edition 2011–08–01. ISO 20749 First edition 2017–03. ISO 28319 Second edition 2018–04. E. General I (Quality Systems/Risk Management) (QS/RM) 5–118 ........... 5–119 ........... Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms. Medical devices—Connectors for reservoir delivery systems for healthcare applications—Part 3: Enteral application. AAMI TIR66:2017. ISO 18250–3 First edition 2018–06. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19–31 ........... American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment. ANSI C63.15–2017 (Revision of ANSI C63.15–2016). G. General Hospital/General Plastic Surgery (GH/GPS) No new entries at this time. H. In Vitro Diagnostics (IVD) 7–282 ........... 7–283 ........... 7–284 ........... Performance Standards for Antifungal Susceptibility Testing of Yeasts ...................... Essential Tools for Implementation and Management of a Point-of-Care Testing Program. Supplemental Tables for Interference Testing in Clinical Chemistry ........................... CLSI M60 1st Edition. CLSI POCT04 3rd Edition. CLSI EP37 1st Edition. I. Materials daltland on DSKBBV9HB2PROD with NOTICES 8–479 ........... VerDate Sep<11>2014 Implants for surgery—Homopolymers, copolymers and blends on poly(lactide)—In vitro degradation testing. 18:12 Oct 19, 2018 Jkt 247001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 ISO 13781 Second edition 2017–07. E:\FR\FM\22OCN1.SGM 22OCN1 53270 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition No. Title of standard 1 Reference No. and date 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 for Ophthalmics—Toric Intraocular Lenses .................... ANSI Z80.30–2018. N. Orthopedic 11–336 ......... 11–337 ......... 11–338 ......... 11–339 ......... 11–340 ......... 11–341 ......... Wear of implant materials—Polymer and metal wear articles—Isolation and characterization. Implants for surgery—Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants. Implants for surgery—Determination of impact resistance of ceramic femoral heads for hip joint prostheses. Implants for surgery—Partial and total hip joint prostheses—Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016)]. Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices. Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements. ISO 17853 Third edition 2011–03–01. ISO 16087 First edition 2013–10–01. ISO 11491 First edition 2017–07. ISO 7206–2 Third edition 2011–04–01 AMENDMENT 1 2016–09–15. ASTM F3018–17. ASTM F3140–17. O. Physical Medicine No new entries at this time. P. Radiology 12–318 ......... 12–319 ......... 12–320 ......... Medical electrical equipment—Part 2–64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment. Medical electrical equipment—Part 2–68: Particular requirements 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. Medical electrical equipment—Medical light ion beam equipment—Performance characteristics. IEC 60601–2–64 Edition 1.0 2014–09. IEC 60601–2–68 Edition 1.0 2014–09. IEC 62667 Edition 1.0 2017–08. Q. Software/Informatics No new entries at this time. R. Sterility 14–515 ......... 14–516 ......... 14–517 ......... Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices. Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration. Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices. ISO 17664 Second edition 2017–10. ASTM F3039–15. ASTM F3293–18. S. Tissue Engineering daltland on DSKBBV9HB2PROD with NOTICES 15–55 ........... 1 All Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds .... ASTM F3259–17. 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 VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 accessed at https://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfStandards/ search.cfm. Such standards are those that FDA has recognized by notice PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22OCN1.SGM 22OCN1 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 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 CDRHStandardsStaff@fda.hhs.gov. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0143] Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with our Foreign Supplier Verification Programs (FSVP) for Food Importers. DATES: Submit either electronic or written comments on the collection of information by December 21, 2018. ADDRESSES: You may submit comments as follows. Please note that late, daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:12 Oct 19, 2018 Jkt 247001 untimely filed comments will not be considered. Electronic comments must be submitted on or before December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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– 2011–N–0143 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers.’’ Received comments, those filed in a timely manner (see PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 53271 ADDRESSES), 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. • 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined E:\FR\FM\22OCN1.SGM 22OCN1
[Pages 53264-53271]
[FR Doc No: 2018-22977]
Number: 050'' (Recognition List Number: 050), will assist manufacturers
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.
List Number: 050.'' Received comments will be placed in the docket and,
Recognition List Number: 050.
access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
An electronic copy of Recognition List Number: 050 is available on
050 modifications and other standards related information. Submit
Number: 050'' to Scott Colburn, Center for Devices and Radiological
66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287. Send one self-
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287,
[[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.
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.
the term ``Recognition List Number: 050'' to identify the current
involve the initial addition of standards not previously recognized by
Old  recognition     recognition   Title of standard      Change \2\
No.               No.              \1\
1-85..............           1-139  ISO 80601-2-61     Withdrawn and
Second edition     replaced with
2017-12            newer version.
version 2018-02)
equipment--Part
2-61: Particular
1-96..............           1-140  ISO 80601-2-55     Withdrawn and
2018-02 Medical    newer version.
2-55: Particular
2-176.............           2-255  ISO 10993-11       Withdrawn and
Third edition      replaced with
2017-09            newer version.
Part 11: Tests
2-204.............           2-256  ASTM F720-17       Withdrawn and
Standard           replaced with
Practice for       newer version.
Testing Guinea
Pigs for Contact
2-233.............           2-257  ASTM F2382-17e1    Withdrawn and
Standard Test      replaced with
Method for         newer version.
3-110.............  ..............  AAMI TIR41:2011/   Reaffirmation.
(R)2017
Report Active
and implantable
3-123.............           3-152  IEC 80601-2-30     Withdrawn and
Edition 1.1 2013-  replaced with
07 Medical         newer version.
2-30: Particular
automated non-
4-214.............           4-242  ISO 10139-1 Third  Withdrawn and
edition 2018-03    replaced with
Dentistry--Soft    newer version.
dentures--Part
1: Materials for
5-42..............  ..............  ASTM D903-98       Reaffirmation.
2017) Standard
Adhesive Bonds.
19-8..............  ..............  IEC 60601-1-2      Extent of
Edition 4.0 2014-  recognition.
1-2: General
performance--Col
disturbances--Re
19-19.............  ..............  IEC TR 60601-4-2   Extent of
Edition 1.0 2016-  recognition.
4-2: Guidance
[[Page 53266]]
19-21.............           19-30  AIM Standard       Withdrawn and
7351731 Rev.       replaced with
2.00 Medical       newer version.
Readers--An AIM
6-123.............  ..............  ASTM E667-98       Reaffirmation.
Mercury[hyphen]i
n[hyphen]Glass,
Self[hyphen]Regi
stering Clinical
6-254.............  ..............  ASTM F2100-11      Reaffirmation.
2018) Standard
6-301.............           6-408  ISO 10555-1        Withdrawn and
2013-06-15         newer version
Intravascular      including
catheters--Steri   amendment.
le and single-
use catheters--
(2017)].
6-352.............           6-409  ASTM F703-18       Withdrawn and
Specification      newer version.
7-127.............           7-275  CLSI EP07 3rd      Withdrawn and
Edition            replaced with
Interference       newer version.
7-171.............           7-276  CLSI M38 3rd       Withdrawn and
Reference Method   newer version.
7-201.............           7-277  CLSI GP41 7th      Withdrawn and
Collection of      newer version.
7-204.............           7-278  CLSI M27 4th       Withdrawn and
7-217.............  ..............  CLSI M60 1st       Title change.
7-240.............  ..............  CLSI M27-S4        Withdrawn. See 7-
Reference Method   217.
Yeasts; Fourth
7-245.............  ..............  CLSI EP09-A3       Withdrawn.
Guideline--Third
7-254.............           7-279  CLSI M07 11th      Withdrawn and
Edition Methods    replaced with
for Dilution       newer version.
Grow Aerobically.
7-258.............           7-280  CLSI M02 13th      Withdrawn and
Performance        newer version.
7-271.............           7-281  CLSI M100 28th     Withdrawn and
8-57..............           8-465  ISO 5832-2 Fourth  Withdrawn and
Implants for       newer version.
surgery--Metalli
c materials--
8-112.............  ..............  ASTM F1044-05      Reaffirmation.
2017)e1 Standard
Shear Testing of
8-128.............           8-466  ASTM F2213-17      Withdrawn and
8-330.............           8-467  ASTM F1978-18      Withdrawn and
8-334.............           8-468  ASTM F2459-18      Withdrawn and
Quantifying via
8-372.............           8-469  ASTM F560-17       Withdrawn and
for Unalloyed
Tantalum for
(UNS R05200, UNS
R05400).
8-380.............  ..............  ASTM F1160-14      Reaffirmation.
8-382.............           8-470  ASTM F2102-17      Withdrawn and
Standard Guide     replaced with
for Evaluating     newer version.
8-390.............           8-471  ASTM F1925-17      Withdrawn and
for Semi-
8-412.............  ..............  ASTM F2537-06      Reaffirmation.
8-414.............           8-472  ASTM F2847-17      Withdrawn and
8-419.............           8-473  ASTM F2885-17      Withdrawn and
for Metal          Extent of
Injection Molded   recognition.
6Aluminum-
8-420.............           8-474  ASTM F2886-17      Withdrawn and
28Chromium-
8-436.............           8-475  ASTM F2026-17      Withdrawn and
Polyetheretherke
tone (PEEK)
8-448.............           8-476  ASTM F2004-17      Withdrawn and
Alloys by
8-454.............           8-477  ASTM F2129-17b     Withdrawn and
of Small Implant
9-43..............           9-117  ISO 16038 Second   Withdrawn and
edition 2017-11    replaced with
Male condoms--     newer version.
use of ISO 4074
and ISO 23409 in
9-67..............  ..............  ASTM D7661-10      Reaffirmation.
9-92..............           9-118  ISO 8637-1 First   Withdrawn and
Extracorporeal     newer version.
purification--Pa
Haemodialysers,
haemodiafilters,
haemoconcentrato
9-95..............           9-119  IEC 60601-2-36     Withdrawn and
Edition 2.0 2014-  replaced with
04 Medical         new recognition
electrical         number.
2-36: Particular
9-112.............           9-120  ASTM D3492-16      Withdrawn and
(Male Condoms).
10-56.............  ..............  ANSI Z80.12-2007   Reaffirmation.
(R2017) American
Ophthalmics--Mul
10-57.............  ..............  ANSI Z80.13-2007   Reaffirmation.
Ophthalmics--Pha
kic Intraocular
10-60.............          10-111  ISO 11981 Third    Withdrawn and
Ophthalmic         newer version.
optics--Contact
care products--
10-67.............          10-112  ISO 11986 Third    Withdrawn and
10-84.............  ..............  ANSI Z80.11-2012   Reaffirmation.
Ophthalmics--Las
er Systems for
11-185............  ..............  ASTM F2267-04      Reaffirmation.
11-197............  ..............  ASTM F983-86       Reaffirmation.
11-199............  ..............  ASTM F565-04       Reaffirmation.
11-203............          11-322  ASTM F1541-17      Withdrawn and
11-224............          11-323  ASTM F2706-17      Withdrawn and
Methods for        newer version.
Constructs in a
11-226............           8-478  ASTM F1089-18      Withdrawn and
Corrosion of       Transferred.
11-227............          11-324  ASTM F366-17       Withdrawn and
Pins and Wires.
11-228............          11-325  ASTM F564-17       Withdrawn and
11-245............          11-326  ASTM F384-17       Withdrawn and
Specifications     newer version.
11-257............          11-327  ASTM F543-17       Withdrawn and
11-261............          11-328  ASTM F1378-17      Withdrawn and
11-271............          11-329  ASTM F2180-17      Withdrawn and
11-284............          11-330  ASTM F2028-17      Withdrawn and
11-288............          11-331  ASTM F2077-17      Withdrawn and
Test Methods for   replaced with
Intervertebral     newer version.
11-296............          11-332  ASTM F2193-18      Withdrawn and
Spinal Skeletal
11-297............          11-333  ASTM F382-17       Withdrawn and
Bone Plates.
11-310............  ..............  ASTM F1611-00      Reaffirmation.
11-315............          11-334  ASTM F1829-17      Withdrawn and
11-318............          11-335  ASTM F3141-17a     Withdrawn and
for Total Knee     newer version.
Loading Profiles.
16-159............          16-202  ISO 7176-2 Third   Withdrawn and
edition 2017-10    replaced with
Wheelchairs--Par   newer version.
16-185............  ..............  ANSI RESNA WC-     Extent of
2:2009 American    recognition.
Wheelchairs--Vol
ume 2,
Scooters) with
21: Requirements
16-193............          16-203  ASME A18.1-2017    Withdrawn and
Safety Standard    replaced with
for Platform       newer version.
12-202............  ..............  IEC 60601-2-43     Recognition
Edition 2.0 2010-  restored with
03 Medical         transition
electrical         period.
2-43: Particular
performance of X-
12-204............  ..............  IEC 60601-2-28     Recognition
2-28: Particular
12-296............          12-317  IEC 60601-2-54     Withdrawn and
CONSOLIDATED       replaced with
VERSION Edition    newer version
1.1 2015-04        including
Medical            amendment.
2-54: Particular
and radioscopy
14-138............          14-512  ISO 13408-2        Withdrawn and
2018-01 Aseptic    newer version.
products--Part
2: Sterilizing
14-275............  ..............  ANSI/AAMI          Reaffirmation.
ST41:2008/
(R)2018 Ethylene
14-293............  ..............  ANSI/AAMI          Reaffirmation.
ST50:2004/
(R)2018 Dry heat
(heated air)
14-294............  ..............  ANSI/AAMI          Reaffirmation.
ST40:2004/
(R)2018 Table-
top dry heat
14-295............  ..............  ANSI/AAMI          Withdrawn. See 14-
ST81:2004/         515.
(R)2016
14-344............          14-513  ASTM F2825-18      Withdrawn and
Stressing of
14-407............          14-514  ISO 11737-1 Third  Withdrawn and
edition 2018-01    replaced with
Sterilization of   newer version.
products--Microb
methods--Part 1:
\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]]
under Recognition List Number: 050.
3-153.................  Standard Guide for Coating  ASTM F2743-11.
Inspection and Acute
Coated Drug-Eluting
Vascular Stent Systems.
3-154.................  Standard Guide for Fatigue- ASTM F3211-17.
to-Fracture (FtF)
3-155.................  Medical electrical          IEC 60601-2-47
equipment--Part 2-47:       Edition 2.0 2012-
Particular requirements     02.
3-156.................  Implants for surgery--      ISO 14708-1 Second
Active implantable          edition 2014-08-15.
safety, marking and for
4-243.................  Corrosion Test Methods....  ANSI/ADA Standard
No. 97:2002/ISO
10271:2001
Reaffirmed by ANSI:
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.
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.
5-118.................  Guidance for the creation   AAMI TIR66:2017.
of physiologic data and
waveform databases to
demonstrate reasonable
assurance of the safety
alarm system algorithms.
5-119.................  Medical devices--           ISO 18250-3 First
Connectors for reservoir    edition 2018-06.
healthcare applications--
Part 3: Enteral
19-31.................  American National Standard  ANSI C63.15-2017
Recommended Practice for    (Revision of ANSI
the Immunity Measurement    C63.15-2016).
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.
8-479.................  Implants for surgery--      ISO 13781 Second
Homopolymers, copolymers    edition 2017-07.
and blends on
poly(lactide)--In vitro
degradation testing.
10-113................  American National Standard  ANSI Z80.30-2018.
for Ophthalmics--Toric
11-336................  Wear of implant materials-- ISO 17853 Third
Polymer and metal wear      edition 2011-03-01.
articles--Isolation and
11-337................  Implants for surgery--      ISO 16087 First
Roentgen                    edition 2013-10-01.
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
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
11-341................  Standard Test Method for    ASTM F3140-17.
Cyclic Fatigue Testing of
Metal Tibial Tray
Components of Unicondylar
Knee Joint Replacements.
12-318................  Medical electrical          IEC 60601-2-64
equipment--Part 2-64:       Edition 1.0 2014-
Particular requirements     09.
light ion beam medical
12-319................  Medical electrical          IEC 60601-2-68
equipment--Part 2-68:       Edition 1.0 2014-
X-ray-based image-guided
for use with electron
accelerators, light ion
and radionuclide beam
12-320................  Medical electrical          IEC 62667 Edition
equipment--Medical light    1.0 2017-08.
ion beam equipment--
14-515................  Processing of health care   ISO 17664 Second
products--Information to    edition 2017-10.
processing of medical
14-516................  Standard Test Method for    ASTM F3039-15.
Detecting Leaks in
Nonporous Packaging or
Materials by Dye
14-517................  Standard Guide for          ASTM F3293-18.
Application of Test Soils
for the Validation of
Cleaning Methods for
15-55.................  Standard Guide for Micro-   ASTM F3259-17.
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
should contain, at a minimum, the following information available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.
[FR Doc. 2018-22977 Filed 10-19-18; 8:45 am]