response to a request regarding the Food and Drug ... › sites › default › files › ... ·...
Transcript of response to a request regarding the Food and Drug ... › sites › default › files › ... ·...
701 Pennsylvania Avenue, NW Suite 800
Washington, D.C. 20004–2654
Tel: 202 783 8700 Fax: 202 783 8750
www.AdvaMed.org
Bringing innovation to patient care worldwide
July 18, 2019
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. FDA-2018-D-1387
Dear Sir/Madam:
The Advanced Medical Technology Association (AdvaMed) provides these comments in
response to a request regarding the Food and Drug Administration (FDA or “Agency”)
Center for Devices and Radiological Health guidance Safety and Performance Based
Pathway. Notice of this final guidance and a request for industry and other stakeholders
to suggest device types for which FDA should consider establishing performance criteria
by, for example, identifying products for which there are comprehensive FDA-recognized
consensus standards were published in Federal Register Vol.84, No.22/Friday, February
1, 2019.
AdvaMed is the world’s largest association representing manufacturers of medical
devices, diagnostic products, and health information systems that are transforming health
care through earlier disease detection, less invasive procedures and more effective
treatments. Our members range from the largest to the smallest medical technology
innovators and companies.
We welcome the opportunity to provide a response to the request for suggested device
types that should be candidates for the Safety and Performance Based Pathway. The
attached document provides a list of device types for which FDA should consider
establishing performance criteria. The document lists the device type number, device
name and, in an effort to aid FDA in preparation of device specific guidances, the related
FDA guidances and international standards for the proposed candidates. For some
devices, all the necessary performance or acceptance criteria are contained in the cited
guidances/standards. For other devices, the relevant FDA guidances and standards listed
describe requirements for the device type, but device specific acceptance criteria are not
provided.
Division of Dockets Management (HFA-305) Docket No. FDA-2018-D-1387
July 18, 2019
Page 2 of 22
AdvaMed understands that FDA intends to maintain a list of device types appropriate for the
Safety and Performance Based Pathway on the FDA Safety and Performance Based Pathway
website, accompanied by the guidance documents that identify the performance criteria for each
device type, as well as the testing methods recommended in the guidances where feasible, and any
other relevant information. AdvaMed supports a viable, voluntary alternate pathway and
appreciates the opportunity to assist FDA in preparing the information that will be provided on
the website and in guidances.
Sincerely,
/s/
Ruey C. Dempsey
Vice President
Technology & Regulatory Affairs
July 18, 2019 AdvaMed Comments Page 3 of 22 Docket No. FDA-2018-D-1387
ADVAMED
PROPOSED SAFETY AND PERFORMANCE ELIGIBLE DEVICE TYPES WITH RELATED
STANDARDS/FDA GUIDANCE
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
870.1250 Percutaneous catheter Class II Special Controls Guidance Document for
Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters
ISO 10555-1 Second edition 2013-06-15
Intravascular catheters - Sterile and single-use
intravascular catheters - Part 1: General
requirements [Including AMENDMENT 1 (2017)]
ISO 10555-4:2013 specifies requirements for
balloon dilatation catheters supplied in the sterile
condition and intended for single use.
870.2100 Cardiovascular blood flowmeter FDA Guidance –
Guidance for Industry and FDA Staff - Information
for Manufacturers Seeking Marketing eligible of
Diagnostic Ultrasound Systems and Transducers
870.5100 Percutaneous transluminal
coronary angioplasty catheter
Class II Special Controls Guidance Document for
Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters
ISO 10555-4:2013 specifies requirements for
balloon dilatation catheters supplied in the sterile
condition and intended for single use.
872.4760 Bone plate
ASTM F1980 Standard Guide for Accelerated
Aging of Sterile Barrier Systems for Medical
Devices
ISO 11607 Packaging for terminally sterilized
medical devices–Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO
11607-1:2006 + Amd 1.:2014)
ASTM F1886 ASTM Standard Test Method for
Determining Integrity of Seals for Flexible
Packaging by Visual Inspection
ASTM F2096 Standard Test Method for Detecting
Gross Leaks in Packaging by Internal Pressurization
(Bubble Test)
July 18, 2019 AdvaMed Comments Page 4 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
ASTM F88 ASTM F88M Standard Test Method for
Seal Strength of Flexible Barrier Materials
DIN EN 556-1 Sterilization of medical devices –
Requirements for medical devices to be designated
"STERILE" – Part 1: Requirements for terminally
sterilized medical devices
DIN EN ISO 11135 Sterilization of health care
products – Ethylene oxide - Requirements for the
development, validation, and routine control of a
sterilization process for medical devices
IEC 62304 Medical device software – Software
lifecycle processes
DIN EN ISO 14630 Non-active surgical implants –
General requirements
DIN EN ISO 14602 Non-active surgical implants –
Implants for osteosynthesis – Particular
requirements
DIN EN 62366 Medical devices – Application of
usability engineering to medical devices
ASTM B214 Standard Test Method for Sieve
Analysis of Metal Powders
ASTM B822 Standard Test Method for Particle Size
Distribution of Metal Powders and Related
Compounds by Light Scattering
ASTM B214 Standard Test Methods for Flow Rate
of Metal Powders Using the Hall Flowmeter Funnel
874.4680 Bronchoscope (flexible or rigid)
and accessories
IEC 60601-2-18: Edition 3.0 2009-08
Medical electrical equipment - Part 2-18: Particular
requirements for the basic safety and essential
performance of endoscopic equipment
876.1075 Gastroenterology-urology biopsy
instrument
FDA Guidance –
Guidance for the Content of Premarket Notifications
for Biopsy Devices Used in Gastroenterology and
Urology
July 18, 2019 AdvaMed Comments Page 5 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
876.1500 Endoscope and accessories IEC 60601-2-2 Edition 6.0 2017-03
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
ISO 8600-5 First edition 2005-03-15
Optics and photonics - Medical endoscopes and
endotherapy devices - Part 5: Determination of
optical resolution of rigid endoscopes with optics
ISO 8600-6 First edition 2005-03-15
Optics and photonics - Medical endoscopes and
endotherapy devices - Part 6: Vocabulary
ISO 8600-3 First edition 1997-07-01 (Amendment 1
2003-12-01
Optics and Optical instruments - Medical
endoscopes and endoscopic accessories - Part 3:
Determination of field of view and direction of view
of endoscopes with optics [Including: Amendment 1
(2003)]
ISO 8600-4 Second Edition 2014-03-15
Endoscopes - Medical endoscopes and certain
accessories - Part 4: Determination of maximum
width of insertion portion
ISO 8600-1 Fourth Edition 2015-10-15
Endoscopes - Medical endoscopes and endotherapy
devices -- Part 1: General requirements
876.4300 Endoscopic electrosurgical unit
and accessories
IEC 60601-2-2 Edition 6.0 2017-03
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
ASTM F1992 -99 (Reapproved 2007)
Standard Practice for Reprocessing of Reusable,
Heat-Stable Endoscopic Accessory Instruments
(EAI) Used with Flexible Endoscopes
876.4480 Electrohydraulic lithotriptor IEC 60601-2-2 Edition 6.0 2017-03
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
July 18, 2019 AdvaMed Comments Page 6 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
876.5010 Biliary catheter and accessories FDA Guidance -
Checklist for Mechanical Lithotripters and Stone
Dislodgers used in Gastroenterology and Urology
876.5130 Urological catheter and
accessories
ASTM F623-99 (Reapproved 2013)
Standard Performance Specification for Foley
Catheter
876.5980 Gastrointestinal tube and
accessories
ISO 80369-3 First Edition 2016-07-01
Small-bore connectors for liquids and gases in
healthcare applications - Part 3: Connectors for
enteral applications.
ISO 18250-3 First edition 2018-06
Medical devices - Connectors for reservoir delivery
systems for healthcare applications - Part 3: Enteral
application
AAMI ANSI ID54:1996/(R)2012
Enteral feeding set adapters and connectors
CEN EN 1615:2000
Enteral feeding catheters and enteral giving sets for
single use and their connectors-design and testing
CEN EN 1618:1997
Catheters other than intravascular catheters - Test
methods for common properties
878.4400 Electrosurgical cutting and
coagulation device and accessories
IEC 60601-2-2 Edition 6.0 2017-03
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
ASTM F1992-99 (Reapproved 2007)
Standard Practice for Reprocessing of Reusable,
Heat-Stable Endoscopic Accessory Instruments
(EAI) Used with Flexible Endoscopes
878.4493 Absorbable poly (glycolid/l-
lactide) surgical suture
Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA
6-415 USP 41-NF36:2018 <881> Tensile Strength
6-416 USP 41-NF36:2018 <861> Sutures –
Diameter
July 18, 2019 AdvaMed Comments Page 7 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
6-417 USP 41-NF36:2018 <871> Sutures – Needle
Attachment
6-420 USP 41-NF36:2018 Absorbable Surgical
Suture
878.4495 Stainless steel suture Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA
6-414 USP 41-NF36:2018 Nonabsorbable Surgical
Suture
6-415 USP 41-NF36:2018 <881> Tensile Strength
6-416 USP 41-NF36:2018 <861> Sutures –
Diameter
6-417 USP 41-NF36:2018 <871> Sutures – Needle
Attachment
878.4810 Laser surgical instrument for use
in general and plastic surgery and
in dermatology
ANSI IESNA RP-27.2-00/R17
Recommended Practice for Photobiological Safety
for Lamps and Lamp Systems - Measurement
Techniques
ANSI IESNA RP-27.3-2007
Recommended Practice for Photobiological Safety
for Lamps - Risk Group Classification and Labeling
IEC 62471 First edition 2006-07
Photobiological safety of lamps and lamp systems
IEC 60825-1 Edition 2.0 2007-03
Safety of laser products - Part 1: Equipment
classification, and requirements [Including:
Technical Corrigendum 1 (2008), Interpretation
Sheet 1 (2007), Interpretation Sheet 2 (2007)]
ANSI IESNA RP-27.1-2015
Recommended Practice for Photobiological Safety
for Lamps and Lamp Systems - General
Requirements
ANSI IESNA RP-27.3-17
Recommended Practice for Photobiological Safety
for Lamps - Risk Group Classification and Labeling
July 18, 2019 AdvaMed Comments Page 8 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
878.4830 Absorbable surgical gut suture Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA
6-415 USP 41-NF36:2018 <881> Tensile Strength
6-416 USP 41-NF36:2018 <861> Sutures –
Diameter
6-417 USP 41-NF36:2018 <871> Sutures – Needle
Attachment
6-420 USP 41-NF36:2018 Absorbable Surgical
Suture
878.4840 Absorbable polydioxanone
surgical suture
Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA
6-415 USP 41-NF36:2018 <881> Tensile Strength
6-416 USP 41-NF36:2018 <861> Sutures –
Diameter
6-417 USP 41-NF36:2018 <871> Sutures – Needle
Attachment
6-420 USP 41-NF36:2018 Absorbable Surgical
Suture
878.5000 Nonabsorbable poly (ethylene
terephthalate) surgical suture
Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA
6-414 USP 41-NF36:2018 Nonabsorbable Surgical
Suture
6-415 USP 41-NF36:2018 <881> Tensile Strength
6-416 USP 41-NF36:2018 <861> Sutures –
Diameter
6-417 USP 41-NF36:2018 <871> Sutures – Needle
Attachment
878.5010 Nonabsorbable polypropylene
surgical suture
Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA
6-414 USP 41-NF36:2018 Nonabsorbable Surgical
Suture
July 18, 2019 AdvaMed Comments Page 9 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
6-415 USP 41-NF36:2018 <881> Tensile Strength
6-416 USP 41-NF36:2018 <861> Sutures –
Diameter
6-417 USP 41-NF36:2018 <871> Sutures – Needle
Attachment
878.5020 Nonabsorbable polyamide surgical
suture
Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA
6-414 USP 41-NF36:2018 Nonabsorbable Surgical
Suture
6-415 USP 41-NF36:2018 <881> Tensile Strength
6-416 USP 41-NF36:2018 <861> Sutures –
Diameter
6-417 USP 41-NF36:2018 <871> Sutures – Needle
Attachment
878.5030 Natural nonabsorbable silk
surgical suture
Class II Special Controls Guidance Document:
Surgical Sutures; Guidance for Industry and FDA
6-414 USP 41-NF36:2018 Nonabsorbable Surgical
Suture
6-415 USP 41-NF36:2018 <881> Tensile Strength
6-416 USP 41-NF36:2018 <861> Sutures –
Diameter
6-417 USP 41-NF36:2018 <871> Sutures – Needle
Attachment
880.5200 Intravascular catheter FDA Guidance on premarket notification (510(k))
submission for short- and long-term intravascular
catheters
ISO 10555-1:2013 – Sterile single-use intravascular
catheters – Part 1: General requirements (including
amendment 1)
ISO 10555-5 Second edition 2013-06-15
Intravascular catheters -- Sterile and single-use
catheters -- Part 5: Over-needle peripheral catheters
July 18, 2019 AdvaMed Comments Page 10 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
ISO 10555-4 Second edition 2013-06-15
Intravascular catheters -- Sterile and single-use
catheters -- Part 4: Balloon dilatation catheters
ISO 11070:2014 – Sterile single-use intravascular
introducers, dilator, and guidewires
ISO 594-1: 1986 – Conical fittings with 6% luer
taper for syringes, needles and certain other medical
equipment – Part 1: General requirements
ISO 594-2: 1998 – Conical fittings with 6% luer
taper for syringes, needles and certain other medical
equipment – Part 2: Lock fittings
880.5440 Intravascular administration set ISO 594-1:1986 Conical fittings with a 6% (luer)
taper of syringes, needles and certain other medical
equipment – Part 1: General requirements
ISO 594-2:1998 Conical fittings with 6% (luer)
taper for syringes, needles, and certain other medical
equipment – Part 2 Locking fittings
ISO 8536-4:2010 Infusion equipment for medical
use – Part 4: Infusion set for single use, gravity feed
ISO 8536-8:2015 Infusion equipment for medical
use – Part 8: Infusion equipment for use with
pressure infusion apparatus
ISO 8536-9:2015 Infusion equipment for medical
use – Part 9: Fluid lines for single use with pressure
infusion equipment
ISO 8536-10:2015 Infusion equipment for medical
use – Part 10: Accessories for fluid lines for single
use with pressure infusion equipment
ISO 14971:2016 Medical devices – Application of
risk management to medical devices
Guidance for Industry and FDA Staff – Intravascular
Administration Sets Premarket Notification
Submission [510(k)], July 11, 2008
ISO 10993-2:2006: Biological evaluation of medical
devices – Part 2: Animal welfare requirements
July 18, 2019 AdvaMed Comments Page 11 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
ISO 10993-4:2002: Biological evaluation of medical
devices – Part 4: Selection of tests for interactions
with blood
ISO 10993-5:2009: Biological evaluation of medical
devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010: Biological evaluation of
medical devices – Part 10: Tests for irritation and
delayed-type hypersensitivity
ISO 10993-11:2006: Biological evaluation of
medical devices – Part 11: Test for systemic toxicity
ISO 10993-12:2012: Biological evaluation of
medical devices – Part 12: Sample preparation and
reference materials
ISO 11137-1:2006 Sterilization of health care
products – Radiation- Part 1: Requirements for
development, validation and routine control of a
sterilization process for medical devices
ISO 11137-2:2006 Sterilization of health care
products – Radiation Part 2 – Establishing the
sterilization dose
ISO 11607:2003 “Packaging for terminally sterilized
medical devices”
ASTM F1980-07: 2002 Standard Guide for
Accelerated Aging of Sterile Barrier Systems for
Medical Devices
ASTM F1140:2000 Standard Test Method for Burst
Testing of Flexible Package Seals Using Internal Air
Pressurization within Restraining Plates
ASTM D4169: 1998 Standard Practice for
Performance Testing of Shipping Containers and
Systems
ASTM-F1929-98(04): 1998 Standard Test Method
for Detecting Seal Leaks in Porous Medical
Packaging by Dye Penetration
ISO 80369-6 Small bore connectors for liquids and
gases in healthcare applications – Part 6: Connectors
for neuraxial applications
July 18, 2019 AdvaMed Comments Page 12 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
880.5570 Hypodermic single lumen needle ISO 80369-7 First edition 2016-10-15
Small-bore connectors for liquids and gases in
healthcare applications - Part 7: Connectors for
intravascular or hypodermic applications
ISO 594-1 First edition 1986-06-15
Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part
1: General requirements
ISO 594-2 Second edition 1998-09-01
Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part
2: Lock fittings
ISO 7886-3 First edition 2005-03-01
Sterile hypodermic syringes for single use -- Part 3:
Auto-disable syringes for fixed-dose immunization
ISO 23908 First edition 2011-06-11
Sharps injury protection - Requirements and test
methods - Sharps protection features for single-use
hypodermic needles, introducers for catheters and
needles used for blood sampling
ISO 11040-5 Third edition 2012-02-15
Prefilled syringes - Part 5: Plunger stoppers for
injectables
ISO 8537 Third edition 2016-03-15
Sterile single-use syringes, with or without needle,
for insulin
ISO 11040-4 Third edition 2015-04-01
Prefilled syringes - Part 4: Glass barrels for
injectables
ISO 7864 Fourth edition 2016-08-01
Sterile hypodermic needles for single use -
Requirements and test methods
ISO 9626 Second edition 2016-08-01
Stainless steel needle tubing for the manufacture of
medical devices - Requirements and test methods
ISO 6009 Fourth edition 2016-08-01
July 18, 2019 AdvaMed Comments Page 13 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
Hypodermic needles for single use - Colour coding
for identification.
ASTM F3212-16
Standard Test Method for Coring Testing of Huber
Needles
880.5970 Intravascular catheter, long-term
>30 days
FDA Guidance on premarket notification (510(k))
submission for short- and long-term intravascular
catheters
ISO 10555-1:2013 – Sterile single-use intravascular
catheters – Part 1: General requirements
ISO 11070:2014 – Sterile single-use intravascular
introducers, dilator, and guidewires
ISO 594-1: 1986 – Conical fittings with 6% luer
taper for syringes, needles and certain other medical
equipment – Part 1: General requirements
ISO 594-2: 1998 – Conical fittings with 6% luer
taper for syringes, needles and certain other medical
equipment – Part 2: Lock fittings
884.1720 Gynecologic laparoscope and
accessories
ISO 8600-5 First edition 2005-03-15
Optics and photonics - Medical endoscopes and
endotherapy devices - Part 5: Determination of
optical resolution of rigid endoscopes with optics
ISO 8600-6 First edition 2005-03-15
Optics and photonics - Medical endoscopes and
endotherapy devices - Part 6: Vocabulary
ISO 8600-3 First edition 1997-07-01 (Amendment 1
2003-12-01
Optics and Optical instruments - Medical
endoscopes and endoscopic accessories - Part 3:
Determination of field of view and direction of view
of endoscopes with optics [Including: Amendment 1
(2003)]
ISO 8600-4 Second Edition 2014-03-15
Endoscopes - Medical endoscopes and certain
accessories - Part 4: Determination of maximum
width of insertion portion
ISO 8600-1 Fourth Edition 2015-10-15
July 18, 2019 AdvaMed Comments Page 14 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
Endoscopes - Medical endoscopes and endotherapy
devices -- Part 1: General requirements
886.5925 Soft (hydrophilic) contact lens
(daily wear)
Class II Special Controls Guidance Document:
Premarket Notification (510(k)) Guidance
Document for Daily Wear Contact Lenses
ANSI Z80.20-2016: Contact lenses – Standard
Terminology, Tolerances, Measurements, and
Physicochemical Properties
ISO 18369: 2017, Parts 1-4 – Ophthalmic optics
ISO 9394: 2012 – Ophthalmic optics – Contact
lenses and contact lens care products –
Determination of biocompatibility by ocular study
with rabbit eyes
ISO 11981:2017 – Ophthalmic optics – Contact
lenses and contact lens care products –
Determination of physical compatibility of contact
lens care products with contact lenses
ISO 11980: 2012 – Ophthalmic optics – Contact
lenses and contact lens care products – Guidance for
clinical investigations
ISO 11986:2017 Contact lenses and contact lens
care products – Guidelines for determination of
preservative uptake and release
ASTM D882-12 - Standard Test Methods for
Tensile Properties of Thin Plastic Sheeting
888.3020 Intramedullary Fixation Rod ASTM F1264-16 Standard Specification and Test
Methods for Intramedullary Fixation Devices
ISO 15142 Implants for surgery - Metal –
Intramedullary nailing; Parts 1, 2 and 3.
888.3030 Single/Multiple component
metallic bone fixation appliances
and accessories
ASTM F543 Standard Specification and Test
Methods for Metallic Medical
Bone Screws
ASTM F382 Standard Specification and Test
Method for Metallic Bone Plates
July 18, 2019 AdvaMed Comments Page 15 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
ASTM F2052 Test Method for Measurement of
Magnetically Induced Displacement Force on
Medical Devices in the Magnetic Resonance
Environment
ASTM F2119 Standard Test Method for
Evaluation of MR Image Artifacts from Passive
Implants
ASTM F2182 Standard Test Method for
Measurement of Radio Frequency Induced Heating
Near Passive Implants During Magnetic Resonance
Imaging
ASTM F2213 Standard Test Method for
Measurement of Magnetically Induced Torque on
Medical Devices in the Magnetic Resonance
Environment
ASTM F2503 Standard Practice for Marking
Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment
888.3310 Hip joint metal/polymer
constrained cemented or
uncemented prosthesis
Class II Special Controls Guidance Document: Hip
Joint Metal/Polymer Constrained Cemented or
Uncemented Prosthesis; Guidance for Industry and
FDA
ISO 7206-4:2010 Implants for surgery – Partial and
total hip joint prostheses – Part 4: Determination of
endurance properties and performance of stemmed
femoral components
ISO 7206-6:2013 Implants for surgery – Partial and
total hip joint prostheses – Part 6: Endurance
properties testing and performance requirements of
neck region of stemmed femoral components
ASTM F2582-2014 Standard Test Method for
Impingement of Acetabular Prostheses
888.3340 Prosthesis, hip, semi-constrained,
composite/metal
ISO 7206-4:2010 Implants for surgery – Partial and
total hip joint prostheses – Part 4: Determination of
endurance properties and performance of stemmed
femoral components
ISO 7206-6:2013 Implants for surgery – Partial and
total hip joint prostheses – Part 6: Endurance
properties testing and performance requirements of
neck region of stemmed femoral components
July 18, 2019 AdvaMed Comments Page 16 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
ASTM F2582-2014 Standard Test Method for
Impingement of Acetabular Prostheses
888.3350 Hip, semi-constrained, cemented,
metal/polymer + additive,
cemented
Prosthesis, hip, semi-constrained,
metal/polymer, cemented
ISO 7206-4:2010 Implants for surgery – Partial and
total hip joint prostheses – Part 4: Determination of
endurance properties and performance of stemmed
femoral components
ISO 7206-6:2013 Implants for surgery – Partial and
total hip joint prostheses – Part 6: Endurance
properties testing and performance requirements of
neck region of stemmed femoral components
ASTM F2582-2014 Standard Test Method for
Impingement of Acetabular Prostheses
888.3353 Hip, semi-constrained, cemented,
metal/ceramic/polymer + additive,
porous uncemented
Prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented
or non-porous cemented,
osteophilic finish
Prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented
or non-porous, uncemented
Draft Guidance Document for the Preparation of
Premarket Notifications for Ceramic Ball Hip
Systems (Pre- and Post-fatigue Burst Strength
Testing)
ISO 7206-5:1992 Implants for surgery – Partial and
total hip joint prostheses – Part 5: Determination of
resistance to static load of head and neck region of
stemmed femoral components
ISO 7206-4:2010 Implants for surgery – Partial and
total hip joint prostheses – Part 4: Determination of
endurance properties and performance of stemmed
femoral components
ISO 7206-6:2013 Implants for surgery – Partial and
total hip joint prostheses – Part 6: Endurance
properties testing and performance requirements of
neck region of stemmed femoral components
ASTM F2582-2014 Standard Test Method for
Impingement of Acetabular Prostheses
888.3358 Hip prosthesis, semi-constrained,
cemented, metal/polymer, +
additive, porous, uncemented
Prosthesis, hip, semi-constrained,
metal/polymer, porous
uncemented
ISO 7206-4:2010 Implants for surgery – Partial and
total hip joint prostheses – Part 4: Determination of
endurance properties and performance of stemmed
femoral components
ISO 7206-6:2013 Implants for surgery – Partial and
total hip joint prostheses – Part 6: Endurance
properties testing and performance requirements of
neck region of stemmed femoral components
July 18, 2019 AdvaMed Comments Page 17 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
Prosthesis, hip, semi-constrained,
uncemented, metal/polymer,
porous
ASTM F2582-2014 Standard Test Method for
Impingement of Acetabular Prostheses
888.3360 Prosthesis, hip, femoral
component, cemented, metal
Prosthesis, hip, semi-constrained,
metal/polymer, uncemented
Prosthesis, upper femoral
ISO 7206-4:2010 Implants for surgery – Partial and
total hip joint prostheses – Part 4: Determination of
endurance properties and performance of stemmed
femoral components
ISO 7206-6:2013 Implants for surgery – Partial and
total hip joint prostheses – Part 6: Endurance
properties testing and performance requirements of
neck region of stemmed femoral components
ASTM F2582-2014 Standard Test Method for
Impingement of Acetabular Prostheses
888.3390 Prosthesis, hip, hemi-, femoral,
metal/polymer, cemented or
uncemented
ISO 7206-4:2010 Implants for surgery – Partial and
total hip joint prostheses – Part 4: Determination of
endurance properties and performance of stemmed
femoral components
ISO 7206-6:2013 Implants for surgery – Partial and
total hip joint prostheses – Part 6: Endurance
properties testing and performance requirements of
neck region of stemmed femoral components
ASTM F2582-2014 Standard Test Method for
Impingement of Acetabular Prostheses
888.3510 Prosthesis, knee, femorotibial,
constrained, cemented,
metal/polymer
ASTM F1800-2012 Standard Practice for Cyclic
Fatigue Testing of Metal Tibial Tray Components of
Total Knee Joint Replacements
888.3520 Prosthesis, knee, femorotibial,
non-constrained, cemented,
metal/polymer
ASTM F1800-2012 Standard Practice for Cyclic
Fatigue Testing of Metal Tibial Tray Components of
Total Knee Joint Replacements
888.3530 Prosthesis, knee, femorotibial,
semi-constrained, cemented,
metal/polymer
ASTM F1800-2012 Standard Practice for Cyclic
Fatigue Testing of Metal Tibial Tray Components of
Total Knee Joint Replacements
888.3535 Knee joint femorotibial (uni-
compartmental) metal/polymer
FDA Guidance: Class II Special Controls Guidance
Document: Knee Joint Patellofemorotibial and
Femorotibial Metal/Polymer Porous-Coated
July 18, 2019 AdvaMed Comments Page 18 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
porous-coated uncemented
prosthesis
Uncemented Prostheses; Guidance for Industry and
FDA
888.3550 Prosthesis, knee,
patello/femorotibial, constrained,
cemented, polymer/metal/polymer
ASTM F1800-2012 Standard Practice for Cyclic
Fatigue Testing of Metal Tibial Tray Components of
Total Knee Joint Replacements
888.3560 Prosthesis, knee,
patello/femorotibial, semi-
constrained, uhmwpe, pegged,
cemented, polymer/metal/polymer
ASTM F1800-2012 Standard Practice for Cyclic
Fatigue Testing of Metal Tibial Tray Components of
Total Knee Joint Replacements
888.3565 Prosthesis, knee,
patello/femorotibial, semi-
constrained, uncemented, porous,
coated, polymer/metal/polymer
ASTM F1800-2012 Standard Practice for Cyclic
Fatigue Testing of Metal Tibial Tray Components of
Total Knee Joint Replacements
FDA Guidance: Class II Special Controls Guidance
Document: Knee Joint Patellofemorotibial and
Femorotibial Metal/Polymer Porous-Coated
Uncemented Prostheses; Guidance for Industry and
FDA
892.1560 Ultrasonic pulsed echo imaging
system
IEC 60601 Series
IEC 62366-1:2015 Usability Engineering to Medical
Devices
IEC 62304: 2015 – Medical Device Software
NEMA UD 2: 2004
892.1570 Diagnostic ultrasonic transducer NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment Revision 3
IEC 61161 Edition 3.0 2013-01
Ultrasonics -- Power measurement -- Radiation force
balances and performance requirements
IEC 60601-2-37 Edition 2.1 2015
Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment
IEC 62359 Edition 2.1 2017-09 CONSOLIDATED
VERSION
Ultrasonics - Field characterization - Test methods
for the determination of thermal and mechanical
July 18, 2019 AdvaMed Comments Page 19 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
indices related to medical diagnostic ultrasonic
fields
892.2050 Picture archiving and
communications system
ISO 14971 Second Edition 2007-03-01: Medical
devices – Application of risk management to
medical devices
IEC 62304 Edition 1.1 2015-06: Medical device
software – Software life cycle processes 04/04/2016
IEC 82304-1 Edition 1.0 2016-10 Health software –
Part 1: General requirements for product safety
08/21/2017
IEC 62366-1 Edition 1.0 2015-02: Medical devices
– Part 1: Application of usability engineering to
medical devices [Including CORRIGENDUM 1
(2016)]
NEMA PS 3.1 – 3.20 (2016) Digital Imaging and
Communications in Medicine (DICOM) Set
06/27/2016
EC ISO 10918-1 First Edition 1994-02-15
Information technology – Digital compression and
coding of continuous-tone still images:
Requirements and guidelines [Including: Technical
Corrigendum 1 (2005)] 01/30/2014
EEE 3333.2.1-2015 IEEE Recommended Practice
for Three-Dimensional (3D) Medical Modeling
08/14/2015
892.2050 Picture archiving and
communications system
Computer Assisted Detection Devices (CAD)
related guidances
Clinical Performance Assessment: Considerations
for Computer-Assisted Detection Devices Applied
to Radiology Images and Radiology Device Data –
Premarket Approval (PMA) and Premarket
Notification [510(k)] Submissions, July 3, 2012
Computer-Assisted Detection Devices Applied to
Radiology Images and Radiology Device Data –
Premarket Notification [510(k)] Submissions, July
3, 2013
July 18, 2019 AdvaMed Comments Page 20 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
892.5050 Linear accelerators generally
Note that some of these may not
be applicable depending on the
type of linear accelerator.
IEC 60976 Edition 2.0 2007: Medical electrical
equipment – Medical electron accelerators –
Functional performance characteristics (FDA
Recognition No. 12-253)
IEC 62083 Edition 2.0 2009: Medical electrical
equipment – Requirements for the safety of
radiotherapy treatment planning systems (FDA
Recognition No. 12-217)
IEC 62274 First Edition 2005: Medical electrical
equipment – Safety of radiotherapy record and
verify systems (FDA Recognition No. 12-241)
IEC 61217 Edition 2.0 2011: Radiotherapy
equipment – Coordinates, movements, and scales
(FDA Recognition No. 12-267)
IEC 60601-2-1 Edition 3.1 2014: 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 MeV14 (FDA
Recognition No. 12-285)
IEC 60731 Edition 3.1 2016: Consolidated Version
Medical electrical equipment – Dosimeters with
ionization chambers as used in radiotherapy (FDA
Recognition No. 12-304)
AAMI RT2:2017 Radiation therapy readiness check
(FDA Recognition No. 12-307)
IEC 60601-2-68 Edition 1.0 2014: 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 (FDA Recognition # 12-319)
IEC 60601-2-64 Edition 1.0 2014: Medical electrical
equipment – Part 2-64: Particular requirements for
the basic safety and essential performance of light
ion beam medical electrical equipment (FDA
Recognition # 12-318)
Guidance for Industry and Food and Drug
Administration Staff: Laser Products – Conformance
with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
July 18, 2019 AdvaMed Comments Page 21 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
(Laser Notice No. 56) (May 2019); 21 CFR Secs.
1040.10 and 1040.11.
892.5750 Radionuclide radiation therapy
systems
Note that some of these may not
be applicable depending on the
type of radiation therapy system
IEC 62083 Edition 2.0 2009: Medical electrical
equipment – Requirements for the safety of
radiotherapy treatment planning systems (FDA
Recognition No. 12-217)
IEC 62274 First Edition 2005: Medical electrical
equipment – Safety of radiotherapy record and
verify systems (FDA Recognition No. 12-241)
IEC 61217 Edition 2.0 2011: Radiotherapy
equipment – Coordinates, movements, and scales
(FDA Recognition No. 12-267)
IEC 60731 Edition 3.1 2016: Consolidated Version
Medical electrical equipment – Dosimeters with
ionization chambers as used in radiotherapy (FDA
Recognition No. 12-304)
AAMI RT2:2017 Radiation therapy readiness check
(FDA Recognition No. 12-307)
IEC 60601-2-68 Edition 1.0 2014: 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 (FDA Recognition # 12-319)
IEC 60601-2-11 Edition 3.0 2013 Medical electrical
equipment – Part 2-11: Particular requirements for
the basic safety and essential performance of gamma
beam therapy equipment (FDA Recognition # 12-
255)
892.5700 Radiation therapy: brachytherapy IEC 60601-2-17 Edition 3.0 2013 Medical electrical
equipment – Part 2-17: Particular requirements for
the safety of automatically-controlled brachytherapy
afterloading equipment (FDA Recognition # 12-272)
892.5900
892.5750
892.5050
Radiation therapy: treatment
planning and information systems
IEC 62083 Edition 2.0 2009 Medical electrical
equipment – Requirements for the safety of
radiotherapy treatment planning systems (FDA
Recognition # 12-217) and (as applicable)
July 18, 2019 AdvaMed Comments Page 22 of 22 Docket No. FDA-2018-D-1387
DEVICE TYPE DEVICE NAME STANDARD/DEVICE-SPECIFIC FDA GUIDANCE
IEC 62274 First Edition 2005 Medical electrical
equipment – Safety of radiotherapy record and
verify systems (FDA Recognition # 12-241)