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.

http://www.advamed.org/

Division of Dockets Management (HFA-305) Docket No. FDA-2018-D-1387

July 18, 2019

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 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)



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



876.1500 Endoscope and accessories IEC 60601-2-2 Edition 6.0 2017-03



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



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





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







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





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



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:


6-414 USP 41-NF36:2018 Nonabsorbable Surgical

Suture


6-416 USP 41-NF36:2018 <861> Sutures –

Diameter


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


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)]



for Lamps and Lamp Systems - General

Requirements



for Lamps - Risk Group Classification and Labeling



878.4830 Absorbable surgical gut suture Class II Special Controls Guidance Document:



6-416 USP 41-NF36:2018 <861> Sutures –

Diameter


Attachment


Suture

878.4840 Absorbable polydioxanone

surgical suture




6-416 USP 41-NF36:2018 <861> Sutures –

Diameter


Attachment


Suture

878.5000 Nonabsorbable poly (ethylene

terephthalate) surgical suture




Suture


6-416 USP 41-NF36:2018 <861> Sutures –

Diameter


Attachment

878.5010 Nonabsorbable polypropylene

surgical suture




Suture




6-416 USP 41-NF36:2018 <861> Sutures –

Diameter


Attachment

878.5020 Nonabsorbable polyamide surgical

suture




Suture


6-416 USP 41-NF36:2018 <861> Sutures –

Diameter


Attachment

878.5030 Natural nonabsorbable silk

surgical suture




Suture


6-416 USP 41-NF36:2018 <861> Sutures –

Diameter


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)


Intravascular catheters -- Sterile and single-use

catheters -- Part 5: Over-needle peripheral catheters




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



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


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


use – Part 8: Infusion equipment for use with

pressure infusion apparatus


use – Part 9: Fluid lines for single use with pressure

infusion equipment


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




devices – Part 4: Selection of tests for interactions

with blood


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


medical devices – Part 11: Test for systemic toxicity


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



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


Conical fittings with a 6% (Luer) taper for syringes,

needles and certain other medical equipment - Part

1: General requirements


Conical fittings with a 6% (Luer) taper for syringes,

needles and certain other medical equipment - Part

2: Lock fittings


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



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






equipment – Part 2: Lock fittings

884.1720 Gynecologic laparoscope and

accessories



endotherapy devices - Part 5: Determination of

optical resolution of rigid endoscopes with optics



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

886.5925 Soft (hydrophilic) contact lens

(daily wear)


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



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


Measurement of Radio Frequency Induced Heating

Near Passive Implants During Magnetic Resonance

Imaging


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


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




femoral components









888.3350 Hip, semi-constrained, cemented,

metal/polymer + additive,

cemented

Prosthesis, hip, semi-constrained,

metal/polymer, cemented




femoral components







888.3353 Hip, semi-constrained, cemented,

metal/ceramic/polymer + additive,

porous uncemented


metal/ceramic/polymer, cemented

or non-porous cemented,

osteophilic finish


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)



resistance to static load of head and neck region of

stemmed femoral components




femoral components







888.3358 Hip prosthesis, semi-constrained,

cemented, metal/polymer, +

additive, porous, uncemented


metal/polymer, porous

uncemented




femoral components








uncemented, metal/polymer,

porous



888.3360 Prosthesis, hip, femoral

component, cemented, metal


metal/polymer, uncemented

Prosthesis, upper femoral




femoral components







888.3390 Prosthesis, hip, hemi-, femoral,

metal/polymer, cemented or

uncemented




femoral components







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


non-constrained, cemented,

metal/polymer





semi-constrained, cemented,

metal/polymer




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



porous-coated uncemented

prosthesis

Uncemented Prostheses; Guidance for Industry and

FDA

888.3550 Prosthesis, knee,

patello/femorotibial, constrained,

cemented, polymer/metal/polymer





patello/femorotibial, semi-

constrained, uhmwpe, pegged,

cemented, polymer/metal/polymer





patello/femorotibial, semi-

constrained, uncemented, porous,

coated, polymer/metal/polymer




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



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



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



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)


equipment – Requirements for the safety of

radiotherapy treatment planning systems (FDA


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


IEC 60731 Edition 3.1 2016: Consolidated Version

Medical electrical equipment – Dosimeters with

ionization chambers as used in radiotherapy (FDA


AAMI RT2:2017 Radiation therapy readiness check



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)



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



(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 62274 First Edition 2005: Medical electrical


verify systems (FDA Recognition No. 12-241)

IEC 61217 Edition 2.0 2011: Radiotherapy

equipment – Coordinates, movements, and scales


IEC 60731 Edition 3.1 2016: Consolidated Version

Medical electrical equipment – Dosimeters with

ionization chambers as used in radiotherapy (FDA


AAMI RT2:2017 Radiation therapy readiness check




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


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


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



Recognition # 12-217) and (as applicable)



IEC 62274 First Edition 2005 Medical electrical


verify systems (FDA Recognition # 12-241)

response to a request regarding the food and drug ... › sites › default › files › ... ·...

Documents