Source: https://www.federalregister.gov/documents/2018/10/22/2018-22977/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized
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Federal Register :: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050
Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective October 22, 2018.
53264-53271 (8 pages)
II. Modifications to the List of Recognized Standards, Recognition List Number: 050
https://www.federalregister.gov/d/2018-22977 https://www.federalregister.gov/d/2018-22977
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.
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.
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.
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 Start Printed Page 53265premarket 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.
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.
1-85 1-139 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 Withdrawn and replaced with newer version.
1-96 1-140 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.
2-176 2-255 ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity Withdrawn and replaced with newer version.
2-204 2-256 ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test Withdrawn and replaced with newer version.
2-233 2-257 ASTM F2382-17e1 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) Withdrawn and replaced with newer version.
3-110 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 Reaffirmation.
3-123 3-152 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 Withdrawn and replaced with newer version.
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.
5-42 ASTM D903-98 (Reapproved 2017) Standard Test Method for Peel or Stripping Strength of Adhesive Bonds Reaffirmation.
19-8 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 Extent of recognition.
19-19 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 Extent of recognition.
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19-21 19-30 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.
6-123 ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury‐in‐Glass, Maximum Self‐Registering Clinical Thermometers Reaffirmation.
6-254 ASTM F2100-11 (Reapproved 2018) Standard Specification for Performance of Materials Used in Medical Face Masks Reaffirmation.
6-301 6-408 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters—Sterile and single-use catheters—Part 1: General requirements [Including AMENDMENT 1 (2017)] Withdrawn and replaced with newer version including amendment.
6-352 6-409 ASTM F703-18 Standard Specification for Implantable Breast Prostheses Withdrawn and replaced with newer version.
7-127 7-275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry Withdrawn and replaced with newer version.
7-171 7-276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi Withdrawn and replaced with newer version.
7-201 7-277 CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens Withdrawn and replaced with newer version.
7-204 7-278 CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts Withdrawn and replaced with newer version.
7-217 CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts Title change.
7-240 CLSI M27-S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement Withdrawn. See 7-217.
7-245 CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition Withdrawn.
7-254 7-279 CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically Withdrawn and replaced with newer version.
7-258 7-280 CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests Withdrawn and replaced with newer version.
7-271 7-281 CLSI M100 28th Edition Performance Standards for Antimicrobial Susceptibility Testing Withdrawn and replaced with newer version.
8-57 8-465 ISO 5832-2 Fourth edition 2018-03 Implants for surgery—Metallic materials—Part 2: Unalloyed titanium Withdrawn and replaced with newer version.
8-112 ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Reaffirmation.
8-128 8-466 ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment Withdrawn and replaced with newer version.
8-330 8-467 ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser Withdrawn and replaced with newer version.
8-334 8-468 ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis Withdrawn and replaced with newer version.
8-372 8-469 ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Withdrawn and replaced with newer version.
8-380 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 Reaffirmation.
8-382 8-470 ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants Withdrawn and replaced with newer version.
8-390 8-471 ASTM F1925-17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants Withdrawn and replaced with newer version.
8-412 ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion Reaffirmation.
8-414 8-472 ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments Withdrawn and replaced with newer version.
8-419 8-473 ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications Withdrawn and replaced with newer version. Extent of recognition.
8-420 8-474 ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications Withdrawn and replaced with newer version.
8-436 8-475 ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications Withdrawn and replaced with newer version.
8-448 8-476 ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis Withdrawn and replaced with newer version.
8-454 8-477 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.
9-43 9-117 ISO 16038 Second edition 2017-11 Male condoms—Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms Withdrawn and replaced with newer version.
9-67 ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms Reaffirmation.
9-92 9-118 ISO 8637-1 First edition 2017-11 Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Withdrawn and replaced with newer version.
9-95 9-119 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 Withdrawn and replaced with new recognition number.
9-112 9-120 ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms) Withdrawn and replaced with newer version.
10-56 ANSI Z80.12-2007 (R2017) American National Standard for Ophthalmics—Multifocal Intraocular Lenses Reaffirmation.
10-57 ANSI Z80.13-2007 (R2017) American National Standard for Ophthalmics—Phakic Intraocular Lenses Reaffirmation.
10-60 10-111 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 Withdrawn and replaced with newer version.
10-67 10-112 ISO 11986 Third edition 2017-11 Ophthalmic optics—Contact lenses and contact lens care products—Determination of preservative uptake and release Withdrawn and replaced with newer version.
10-84 ANSI Z80.11-2012 (R2017) American National Standard for Ophthalmics—Laser Systems for Corneal Reshaping Reaffirmation.
11-185 ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression Reaffirmation.
11-197 ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components Reaffirmation.
11-199 ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments Reaffirmation.
11-203 11-322 ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices Withdrawn and replaced with newer version.
11-224 11-323 ASTM F2706-17 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model Withdrawn and replaced with newer version.
11-226 8-478 ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments Withdrawn and replaced with newer version. Transferred.
11-227 11-324 ASTM F366-17 Standard Specification for Fixation Pins and Wires Withdrawn and replaced with newer version.
11-228 11-325 ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples Withdrawn and replaced with newer version.
11-245 11-326 ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices Withdrawn and replaced with newer version.
11-257 11-327 ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws Withdrawn and replaced with newer version.
11-261 11-328 ASTM F1378-17 Standard Specification for Shoulder Prostheses Withdrawn and replaced with newer version.
11-271 11-329 ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables Withdrawn and replaced with newer version.
11-284 11-330 ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation Withdrawn and replaced with newer version.
11-288 11-331 ASTM F2077-17 Test Methods for Intervertebral Body Fusion Devices Withdrawn and replaced with newer version.
11-296 11-332 ASTM F2193-18 Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System Withdrawn and replaced with newer version.
11-297 11-333 ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates Withdrawn and replaced with newer version.
11-310 ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers Reaffirmation.
11-315 11-334 ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear Withdrawn and replaced with newer version.
11-318 11-335 ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles Withdrawn and replaced with newer version.
16-159 16-202 ISO 7176-2 Third edition 2017-10 Wheelchairs—Part 2: Determination of dynamic stability of electric wheelchairs Withdrawn and replaced with newer version.
16-185 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 Extent of recognition.
16-193 16-203 ASME A18.1-2017 Safety Standard for Platform Lifts and Stairway Chairlifts Withdrawn and replaced with newer version.
12-202 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 Recognition restored with transition period.
12-204 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 X-ray tube assemblies for medical diagnosis Recognition restored with transition period.
12-296 12-317 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)] Withdrawn and replaced with newer version including amendment.
14-138 14-512 ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products—Part 2: Sterilizing filtration Withdrawn and replaced with newer version.
14-275 ANSI/AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness Reaffirmation.
14-293 ANSI/AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers Reaffirmation.
14-294 ANSI/AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities Reaffirmation.
14-295 ANSI/AAMI ST81:2004/(R)2016 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices Withdrawn. See 14-515.
14-344 14-513 ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery Withdrawn and replaced with newer version.
14-407 14-514 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.
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.
3-153 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems ASTM F2743-11.
3-154 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices ASTM F3211-17.
3-155 Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems IEC 60601-2-47 Edition 2.0 2012-02.
3-156 Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer ISO 14708-1 Second edition 2014-08-15.
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 for rotary instruments ISO 8325 Second edition 2004-09-15.
4-245 Dentistry—Corrosion test methods for metallic materials ISO 10271 Second edition 2011-08-01.
4-246 Dentistry—Pre-capsulated dental amalgam ISO 20749 First edition 2017-03.
4-247 Dentistry—Laser welding and filler materials ISO 28319 Second edition 2018-04.
5-118 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms AAMI TIR66:2017.
5-119 Medical devices—Connectors for reservoir delivery systems for healthcare applications—Part 3: Enteral application ISO 18250-3 First edition 2018-06.
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).
7-282 Performance Standards for Antifungal Susceptibility Testing of Yeasts CLSI M60 1st Edition.
7-283 Essential Tools for Implementation and Management of a Point-of-Care Testing Program CLSI POCT04 3rd Edition.
7-284 Supplemental Tables for Interference Testing in Clinical Chemistry CLSI EP37 1st Edition.
8-479 Implants for surgery—Homopolymers, copolymers and blends on poly(lactide)—In vitro degradation testing ISO 13781 Second edition 2017-07.
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10-113 American National Standard for Ophthalmics—Toric Intraocular Lenses ANSI Z80.30-2018.
11-336 Wear of implant materials—Polymer and metal wear articles—Isolation and characterization ISO 17853 Third edition 2011-03-01.
11-337 Implants for surgery—Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants ISO 16087 First edition 2013-10-01.
11-338 Implants for surgery—Determination of impact resistance of ceramic femoral heads for hip joint prostheses ISO 11491 First edition 2017-07.
11-339 Implants for surgery—Partial and total hip joint prostheses—Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016)] ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15.
11-340 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices ASTM F3018-17.
11-341 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements ASTM F3140-17.
12-318 Medical electrical equipment—Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment IEC 60601-2-64 Edition 1.0 2014-09.
12-319 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 IEC 60601-2-68 Edition 1.0 2014-09.
12-320 Medical electrical equipment—Medical light ion beam equipment—Performance characteristics IEC 62667 Edition 1.0 2017-08.
14-515 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices ISO 17664 Second edition 2017-10.
14-516 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration ASTM F3039-15.
14-517 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices ASTM F3293-18.
15-55 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds ASTM F3259-17.
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 Start Printed Page 53271appeared 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.