4274 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 

classified in class II. They were 

originally classified before the 

enactment of provisions of the Safe 

Medical Devices Act of 1990 (Pub. L. 

101–629), which broadened the 

definition of class II devices and now 

permit FDA to establish special controls 

beyond performance standards, 

including guidance documents, to help 

provide reasonable assurance of the 

safety and effectiveness of such devices. 

In December 2000, Congress enacted 

Public Law 106–554, which directed 

FDA to ‘‘reexamine existing condom 

labels’’ and ‘‘determine whether the 

labels are medically accurate regarding 

the overall effectiveness or lack of 

effectiveness in preventing sexually 

transmitted diseases * * *.’’ In 

response, FDA recommended labeling 

intended to provide important 

information for condom users, including 

the extent of protection provided by 

condoms against various types of 

sexually transmitted diseases. 

Respondents to this collection of 

information are manufacturers and 

repackagers of male condoms made of 

natural rubber latex without spermicidal 

lubricant. FDA expects approximately 

five new manufacturers or repackagers 

to enter the market yearly and to 

collectively have a third-party 

disclosure burden of 60 hours. The 

number of respondents cited in table 1 

of this document is based on FDA’s 

database of premarket submissions and 

the electronic registration and listing 

database. The average burden per 

disclosure was derived from a study 

performed for FDA by Eastern Research 

Group, Inc., an economic consulting 

firm, to estimate the impact of the 1999 

over-the-counter (OTC) human drug 

labeling requirements final rule (64 FR 

13254, March 17, 1999). Because the 

packaging requirements for condoms are 

similar to those of many OTC drugs, we 

believe the burden to design the labeling 

for OTC drugs is an appropriate proxy 

for the estimated burden to design 

condom labeling. 

The special controls guidance 

document also refers to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 

part 807 subpart E have been approved 

under OMB control number 0910–0120; 

and the collections of information in 21 

CFR part 820 have been approved under 

OMB control number 0910–0073. 

The collection of information under 

21 CFR 801.437 does not constitute a 

‘‘collection of information’’ under the 

Paperwork Reduction Act of 1995. 

Rather, it is a ‘‘public disclosure of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of disclosure to the public’’ 

(5 CFR 1320.3(c)(2)). 

In the Federal Register of October 15, 

2014 (79 FR 61874), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Class II Special Controls Guidance Document: Labeling for Natural 

Rubber Latex Condoms Classified Under 21 CFR 884.5300 ............. 5 1 5 12 60 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: January 21, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01403 Filed 1–26–15; 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: 

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 selfaddressed 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, 


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Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 4275 

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: PositivePressure 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. 


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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

recognition No. 

Replacement 

recognition No. Title of standard 1 Change 

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) epsiv;1 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-MolecularWeight Polyethylene Powder and Fabricated Form for Surgical Implants.Withdrawn and replaced with 

newer version. 


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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

recognition No. 

Replacement 

recognition No. Title of standard 1 Change 

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. 


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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

recognition No. 

Replacement 

recognition No. Title of standard 1 Change 

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. 

1All 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. 


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TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference No. and date 

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-onHard 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. 

1All standard titles in this table conform to the style requirements of the respective organizations. 


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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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0198] 

Current Good Manufacturing Practice 

Requirements for Combination 

Products; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry and FDA staff entitled ‘‘Current 

Good Manufacturing Practice 

Requirements for Combination 

Products.’’ The guidance describes and 

explains the final rule on current good 

manufacturing practice (CGMP) 

requirements for combination products, 

including presenting general 

considerations for CGMP compliance as 

well as analysis of hypothetical 

scenarios. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by March 30, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Current Good 

Manufacturing Practice Requirements 

for Combination Products’’ to the Office 

of Combination Products, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5129, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance 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: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

MD 20993–0002, 301–796–8930. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and FDA 

staff entitled ‘‘Current Good 

Manufacturing Practice Requirements 

for Combination Products.’’ The 

guidance provides background on 

combination products, including an 

overview of the final rule on CGMP 

requirements for combination products 

(78 FR 4307, January 22, 2013) (21 CFR 

part 4) and the role of the lead center 

and other Agency components with 

respect to combination product CGMP 

issues. The guidance addresses general 

considerations for CGMP requirements 

for combination products and the 

purpose and content of specific CGMP 

provisions addressed in part 4. The 

guidance also contains hypothetical 

scenarios intended to clarify how to 


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