Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 038

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: 038

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 038” (Recognition List Number: 038), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit either electronic or written comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.

ADDRESSES:

An electronic copy of Recognition List Number: 038 is available on the Internet at

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 038 modifications and other standards related information.

Submit written requests for a single copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 038” to the Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149.

Submit electronic comments on this document to

http://www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring,

MD 20993, 301-796-6287,

standards@cdrh.fda.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 premarket review submissions or other requirements.

In a notice published in the

Federal Register

of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards.

Modifications to the initial list of recognized standards, as published in the

Federal Register

, can be accessed at

http://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. Both versions are publicly accessible at the Agency's Internet site. See section VI for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List Number: 038

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA will use the term “Recognition List Number: 038” to identify these 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

A. Anesthesia

1-57

ASTM F1101-90 (Reapproved 2003) Standard Specification for Ventilators Intended for Use During Anesthesia

Withdrawn.

1-69

ASTM F1464-93 (Reapproved 2005) Standard Specification for Oxygen Concentrators for Domiciliary Use

Withdrawn.

1-70

ASTM F1246-91 (Reapproved 2005) Standard Specification for Electrically Powered Home Care Ventilators—Part 1: Positive-Pressure Ventilators and Ventilator Circuits

Withdrawn.

1-94

ISO 8359 Second edition 1996-12-15, Oxygen concentrators for medical use—safety requirements [including amendment 1 (2012)]

Withdrawn. See 1-102.

B. Biocompatibility

2-143

2-213

ASTM F1904-14 Standard Practice for the Biological Responses to Particles in vivo

Withdrawn and replaced with newer version.

2-144

2-214

ASTM F619-14 Standard Practice for Extraction of Medical Plastics.

Withdrawn and replaced with newer version.

C. Cardiovascular

3-88

ASTM F2514-08 (Reapproved 2014) Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

Reaffirmation.

3-123

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

Extent of recognition and Process impacted.

D. Dental/ENT

4-117

ANSI/ADA Specification No. 12: 2002 (Reaffirmed 2008) Denture base polymers

Withdrawn.

4-134

4-213

ISO 7494-1 Second edition 2011-08-15 Dentistry—Dental units—Part 1: General requirements and test methods

Withdrawn and replaced with newer version.

4-135

4-214

ISO 10139-1 Second edition 2005-02-15, Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use [Including: Technical Corrigendum 1 (2006)]

Withdrawn and replaced with newer version including technical corrigendum.

4-136

ASTM F2504-05 (Reapproved 2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

Reaffirmation.

4-143

4-215

ANSI/ADA Standard No. 96: 2012 Dental Water-based Cements

Withdrawn and replaced with newer version.

4-159

4-216

ANSI/IEEE ANSI C63.19-2011 American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids

Withdrawn and replaced with newer version.

4-170

4-217

ANSI/ASA S3.36-2012 American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements

Withdrawn and replaced with newer version.

4-183

ANSI/ASA S3.2-2009 (Reaffirmed 2014) American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems

Reaffirmation.

4-185

ANSI/ASA S3.45-2009 (Reaffirmed 2014) American National Standard Procedures for Testing Basic Vestibular Function

Reaffirmation.

E. General I (Quality Systems/Risk Management (QS/RM))

5-48

ANSI/ASQ Z1.9-2003 (R2013) Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming

Reaffirmation.

5-57

ANSI/AAMI HE75:2009/(R)2013 Human factors engineering—Design of medical devices

Reaffirmation.

5-62

ANSI/ASQ Z1.4-2003 (R2013) Sampling Procedures and Tables for Inspection by Attributes

Reaffirmation.

F. General Hospital/General Plastic Surgery (GH/GPS)

6-199

6-335

ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

Withdrawn and replaced with newer version.

6-217

ASTM F1670/F1670M-08 (Reapproved 2014)

ε1

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

Reaffirmation.

6-228

6-336

IEC 60601-2-2 Edition 5.0 2009-02 Medical Electrical Equipment—Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories [Including: Technical Corrigendum 1 (2014)]

Withdrawn and replaced with newer version including technical corrigendum.

6-231

6-337

ANSI/AAMI/IEC 60601-2-20:2009 Medical Electrical Equipment—Part 2-20: Particular Requirements for the Basic Safety and Essential Performance of Infant Transport Incubators [Including: Erratum (2012)]

Withdrawn and replaced with newer version including erratum.

G. In Vitro Diagnostics (IVD)

7-84

CEN 13640, Stability Testing of In Vitro Diagnostic Reagents

Withdrawn.

7-162

CLSI POCT14-A (Formerly H49-A) Point-Of-Care Monitoring of Anticoagulation Therapy; Approved Guideline

Withdrawn duplicate. See 7-112.

7-184

7-250

CLSI M40-A2 Quality Control of Microbiological Transport Systems; Approved Standard—Second Edition

Withdrawn and replaced with newer version.

H. Materials

8-111

8-380

ASTM F1160-14 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

Withdrawn and replaced with newer version.

8-124

8-381

ASTM F2052-14 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

Withdrawn and replaced with newer version.

8-171

ASTM F1609-08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Reaffirmation.

8-198

8-382

ASTM F2102-13 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

Withdrawn and replaced with newer version.

8-207

8-383

ASTM F1926/F1926M-14 Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

Withdrawn and replaced with newer version.

8-340

8-384

ASTM F2026-14 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-357

8-385

ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

Withdrawn and replaced with newer version.

I. OB-GYN/Gastroenterology/Urology

9-6

9-95

IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment—Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

Withdrawn and replaced with newer version.

9-45

ASTM F2528−06 (Reapproved 2014) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

Reaffirmation.

9-62

9-96

IEC 60601-2-2 Edition 5.0 2009-02 Medical Electrical Equipment—Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories [Including: Technical Corrigendum 1 (2014)]

Withdrawn and replaced with newer version including technical corrigendum.

9-74

9-97

ISO 13958 Third edition 2014-04-01 Concentrates for haemodialysis and related therapies

Withdrawn and replaced with newer version.

9-76

9-98

ISO 13959 Third edition 2014-04-01 Water for haemodialysis and related therapies

Withdrawn and replaced with newer version.

9-77

9-99

ISO 23500 Second edition 2014-04-01 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

Withdrawn and replaced with newer version.

9-78

9-100

ISO 11663 Second edition 2014-04-01 Quality of dialysis fluid for haemodialysis and related therapies

Withdrawn and replaced with a newer version.

9-79

9-101

ISO 26722 Second edition 2014-04-01 Water treatment equipment for haemodialysis applications and related therapies

Withdrawn and replaced with a newer version.

9-82

9-102

ISO 4074 Second edition 2014-08-15 Natural rubber latex male condoms—Requirements and test methods

Withdrawn and replaced with newer version.

J. Ophthalmic

10-49

10-90

ISO 11979-9 First edition 2006-09-01 Ophthalmic implants—Intraocular lenses—Part 9: Multifocal intraocular lenses [Including: Amendment 1(2014)]

Withdrawn and replaced with newer version including amendment.

10-50

10-91

ISO 11979-10 First edition 2006-08-15 Ophthalmic implants—Intraocular lenses—Part 10: Phakic intraocular lenses [Including: Amendment 1 (2014)]

Withdrawn and replaced with newer version including amendment.

10-80

ISO 18369-2 Second edition 2012-12-01 Ophthalmic optics—Contact lenses—Part 2: Tolerances

Extent of recognition and relevant guidance.

K. Orthopedic

11-196

11-281

ASTM F1672-14 Standard Specification for Resurfacing Patellar Prosthesis

Withdrawn and replaced newer version.

11-213

11-282

ASTM F1223-14 Standard Test Method for Determination of Total Knee Replacement Constraint

Withdrawn and replaced with newer version.

11-260

11-283

ASTM F2943-14 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

Withdrawn and replaced with newer version.

11-263

11-284

ASTM F2028-14 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

Withdrawn and replaced with newer version.

L. Physical Medicine

16-189

16-193

ASME A18.1-2014 Safety Standard for Platform Lifts and Stairway Chairlifts

Withdrawn and replaced with newer version.

M. Radiology

12-181

12-284

NEMA NU 1-2012 Performance Measurements of Gamma Cameras.

Withdrawn and replaced with newer version.

12-206

12-285

IEC 60601-2-1 Edition 3.1 2014-07 Medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

Withdrawn and replaced with newer version.

12-230

NEMA XR 24-2008 (R2014) Primary User Controls for Interventional Angiography X-Ray Equipment

Reaffirmation.

N. Sterility

14-139

ISO 14644-1 First edition 1999-05-01 Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness

Relevant guidance.

14-140

ISO 14644-2 First edition 2000-09-15 Cleanrooms and associated controlled environments—Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

Relevant guidance.

14-141

ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments—Part 4: Design, construction and start-up

Relevant guidance.

14-165

ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments—Part 5: Operations

Relevant guidance.

14-166

ISO 14644-7 First edition 2004-10-01 Cleanrooms and associated controlled environments—Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

Relevant guidance.

14-193

ANSI/AAMI/ISO 11607-1:2006/(R)2010, Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems

Relevant guidance.

14-194

ANSI/AAMI/ISO 11607-2:2006/(R)2010, Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

Relevant guidance.

14-238

AAMI/ANSI/ISO 11140-5:2007/(R)2012, Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs

Relevant guidance.

14-242

ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments—Part 3: Test methods

Relevant guidance.

14-243

ISO 14644-6 First edition Cleanrooms and associated controlled environments—Part 6: Vocabulary

Relevant guidance.

14-274

ANSI/AAMI/ISO 15882:2008/(R)2013, Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results

Reaffirmation.

14-299

14-453

ASTM F2097-14 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

Withdrawn and replaced with newer version.

14-355

14-454

ISO 11607-1 First edition 2006-04-15 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]

Withdrawn and replaced with newer version including amendment.

14-356

14-455

ISO 11607-2 First edition 2006-04-15 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]

Withdrawn and replaced with newer version including amendment.

14-379

ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments—Part 8: Classification of air cleanliness by chemical concentration (ACC)

Relevant guidance.

14-389

ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments—Part 9: Classification of surface cleanliness by particle concentration

Relevant guidance.

14-390

ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments—Part 10: Classification of surface cleanliness by chemical concentration

Relevant guidance.

1

All standard titles in this table conform to the style requirements of the respective organizations.

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: 038.

Table 2—New Entries to the List of Recognized Standards

Recognition No.

Title of standard

1

Reference No. and date

A. Anesthesia

1-102

Medical electrical equipment—Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

ISO 80601-2-69 First edition 2014-07-15.

B. Cardiovascular

3-133

International Standard-Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques

ISO 5840-3 First edition 2013-03-01.

C. Dental/Ear, Nose, and Throat

4-218

International Standard-Dentistry—Brackets and tubes for use in orthodontics

ISO 27020 First edition 2010-12-15.

4-219

International Standard-Dentistry-Adhesive-Notched Edge Sheer Bond Strength Test

ISO 29022 First edition 2013-06-01.

D. General Hospital/General Plastic Surgery

6-338

Standard Specification for Radiation Attenuating Protective Gloves

ASTM D7866-14a.

6-339

Standard Consumer Safety Specification for Full-Size Baby Cribs

ASTM F1169-13.

6-340

Standard Consumer Safety Performance Specification for Commercial Cribs

ASTM F2710-13.

E. Nanotechnology

18-3

Technical Specification—Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method

ISO/TS 14101 First edition 2012-11-01.

F. Neurology

17-13

IEEE Recommended Practice for Neurofeedback Systems

IEEE Std 2010-2012.

G. Ophthalmics

10-92

American National Standard for Ophthalmics-Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical Properties

ANSI Z80.20-2010 (Revision of ANSI Z80.20-2004) 12/06/2010.

10-93

American National Standard for Ophthalmics-Implantable Glaucoma Devices

ANSI Z80.27-2014 (revision of ANSI Z80.27-2001 (R2011)) 01/27/2014.

H. Orthopedic

11-285

Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging

ASTM F2978-13.

11-286

Guide For the Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Prostheses

ASTM F2979-14.

I. Radiology

12-286

X-ray Equipment for Interventional Procedures—User Quality Control Mode

NEMA XR-27-2013 with Amendment 1.

12-287

Supplemental Requirements for User Information and System Function Related to Dose in CT

NEMA XR 28-2013.

12-288

Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI)

NEMA MS 9-2008.

J. Software/Informatics

13-70

Application of risk management for IT-networks incorporating medical devices—Part 2-5: Application guidance—Guidance on distributed alarm systems

IEC TR 80001-2-5 2014.

13-71

Logical Observation Identifiers Names and Codes (LOINC)

LOINC 2.48 2014-06-27.

13-72

Health informatics—Personal health device communication, Part 10425: Device Specialization—Continuous Glucose Monitor (CGM)

IEEE Std 11073-10425-2014.

K. Sterility

14-456

Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2

ISO/TS 16775 First edition 2014-05-15.

1

All standard titles in this table conform to the style requirements of the respective organizations.

IV. List of Recognized Standards

FDA maintains the Agency's current list of FDA Recognized Consensus Standards in a searchable database that may be accessed directly at FDA's Internet site at

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

FDA will incorporate the modifications and revisions described in this notice into the database and, upon publication in the

Federal Register

, this recognition of consensus standards will be effective. 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. Beginning with Recognition List 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes.

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

standards@cdrh.fda.gov.

To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page,

http://www.fda.gov/MedicalDevices,

includes a link to standards-related documents including the guidance and the current list of recognized standards. After publication in the

Federal Register

, this notice announcing “Modification to the List of Recognized Standards, Recognition List Number: 038” will be available at

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” at

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

VII. Submission of Comments and Effective Date

Interested persons may submit either electronic comments regarding this document to

http://www.regulations.gov

or written comments to the Division of Dockets Management (see

ADDRESSES

). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at

http://www.regulations.gov.

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: 038. These modifications to the list of recognized standards are effective upon publication of this notice in the

Federal Register

.

Dated: January 22, 2015.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2015-01420 Filed 1-26-15; 8:45 am]

BILLING CODE 4164-01-P