Welcome to today’s 

FDA/CDRH Webinar

Thank you for your patience while we register all of 

today’s participants.

If you have not connected to the audio portion of the 

webinar, please do so now:

Dial: 888-566-6189; Passcode: 6985841

International Dialers: 1-517-308-9280; 

Passcode: 6985841
Medical Device Accessories – 

Describing Accessories and 

Classification Pathway for New 

Accessory Types: Final Guidance 

Erica Takai, PhD

Assistant Director for Guidance Management

Center for Devices and Radiological Health

February 2, 2017 CDRH Webinar
3 

Agenda

• Key Take-Aways

• Overview of the Accessories Guidance

– Background and Scope

– Classification of Accessories 

– Key Definitions

– Applying the Accessories Policy 

• Q & A
4 

Key Take-Aways

• The FDA is taking a risk-based approach to 

classifying accessories when used as intended with 

a parent device 

– New types of accessories can be a lower classification 

than the parent device

– The FDA encourages manufacturers to use the de novo

process to request risk-based classification of new types 

of accessories 

• The final Accessories Guidance provides 

clarification on the definition of a medical device 

accessory 
5 

Accessories Guidance Background

• Draft Guidance on Medical Device Accessories 

published January 20, 2015

• We received 10 sets of comments

• No significant policy changes resulted from the 

comment period 

• Final guidance published December 30, 2016
6 

Scope of Guidance

• Only applicable to devices under section 201(h) 

of the Food, Drug, and Cosmetic Act (FD&C Act)

– Scope of “Software as a Medical Device” (SaMD) is 

limited to those that meet the definition of a device 

under the FD&C Act

• Focuses on the use of the de novo classification 

process to classify accessories of a new type 
7 

What about existing accessories?

• Reclassification under 513(e) and 513(f)(3) of 

the FD&C Act for existing accessories

– Principles in guidance apply to existing accessories

• Through Medical Device User Fee Amendments 

IV (MDUFA IV) user fee negotiations, the FDA 

and industry have committed to working 

together to identify the appropriate 

reclassification pathway for existing Class III 

accessories 
8 

Historical Regulation of 

Accessories

• Inclusion in the same classification as the parent 

device 

– Through 510(k) Premarket Notification clearance 

• substantial equivalence to another accessory or 

to another 510(k) cleared device

– Premarket Application (PMA) approval

– Explicit inclusion in classification regulation or 

reclassification order for the parent device. 

• Issuance of a unique, separate classification 

regulation for the accessory
9 

Approach Moving Forward:

Risk-Based Classification of Accessories

• On December 13, 2016, section 513(b) of the 

FD&C Act was amended by the 21st Century 

Cures Act to state that the “Secretary shall 

classify an accessory ... based on the intended 

use of the accessory, notwithstanding the 

classification of any other device with which 

such accessory is intended to be used.” 
10

Risk-Based Classification of Accessories

• Classification of accessories should reflect the 

risks of the accessory device when used as 

intended 

– Some accessories can have a lower risk profile than 

the parent device & be regulated in a lower class

– Some accessories can have the same risk profile as 

the parent device & be regulated in the same class 
11

Definitions

• Accessory: A finished device that is intended to 

support, supplement, and/or augment the 

performance of one or more parent devices. 

• Finished Device (21 CFR 820.3(l)): “[A]ny device 

or accessory to any device that is suitable for 

use or capable of functioning, whether or not it 

is packaged, labeled, or sterilized.” 
12

Definitions

• Parent Device: A finished device whose 

performance is supported, supplemented, 

and/or augmented by one or more accessories. 

• Component (21 CFR 820.3(c)): “[A]ny raw 

material, substance, piece, part, software, 

firmware, labeling, or assembly which is 

intended to be included as part of the finished, 

packaged, and labeled device.”
13

Applying the Accessory 

Classification Policy

1. Is the device an accessory? 

a. Is it intended for use with one or more parent 

devices?

b. Is it intended to support, supplement, and/or 

augment the performance of one or more parent 

devices? 

2. What are the risks of the accessory when used 

as intended with the parent device(s) and what 

regulatory controls are necessary to provide a 

reasonable assurance of its safety and 

effectiveness? 
14

1. Is the device an accessory?

a. Is the device intended for use with one or 

more parent devices?

– Determined by the labeling for the potential 

accessory device (not of the parent device)

– Articles used with a device that are not finished 

devices are not accessories e.g.,:

• Off-the-shelf computer monitor and peripherals
15

1. Is the device an accessory?

b. Is the device intended to support, supplement, 

and/or augment the performance of one or 

more parent devices? 

– Does it support the performance of a parent device 

by enabling or facilitating that device to perform 

according to its intended use? e.g.,:

• Tunneling tool for use with a neurostimulator to 

enable proper lead placement

• Infusion pump stand
16

1. Is the device an accessory?

b. Is it intended to support, supplement, and/or 

augment the performance of one or more 

parent devices? 

– Does it supplement the performance of a parent 

device by adding a new function/new way of using 

the parent device without changing the intended 

use of the parent device? e.g.,:

• New delivery system that expands the patient 

population in which the parent device can be 

used

• Input device (e.g., thermometer) to a multiparameter monitor
17

1. Is the device an accessory?

b. Is it intended to support, supplement, and/or 

augment the performance of one or more 

parent devices? 

– Does it augment the performance of a parent 

device by enabling the device to perform its 

intended use more safely or effectively? e.g.,:

• Bone cutting guides used to assist in the 

positioning of total hip or knee arthroplasty 

components 

• Color/contrast filters to enhance raw images 

generated from the parent imaging device
18

Software as a Medical Device 

(SaMD) 

• SaMD – software intended to be used for one or more 

medical purposes that perform these purposes without 

being part of a hardware medical device. See the 

International Medical Device Regulators Forum 

(IMDRF) SaMD WG/N10 Final Document: Software as a 

Medical Device 

(http://www.imdrf.org/docs/imdrf/final/technical/imd

rf-tech-131209-samd-key-definitions-140901.pdf) 

• SaMD that meet the definition of a device under the 

FD&C Act 

– similar to other stand-alone devices SaMD are 

classified according to their risk
19

Software as a Medical Device 

(SaMD) 

• SaMD using data from another device 

– does not automatically become an accessory, 

– is not considered to support, supplement, and/or 

augment the performance of a parent device 

– For example, a stand-alone software program that is 

intended to analyze radiological images is not 

considered an accessory

• SaMD is considered an accessory

– when SaMD is used in combination (e.g., as a 

module) with other devices and supports, 

supplements, and/or augments the performance of 

these other parent devices
20

Accessory Determination Example

• A stand-alone pulse oximeter 

– Not intended to be used with a parent device

– Not intended to support, supplement or augment a 

parent device

Not an accessory

• A pulse oximeter intended to be used with a multi- parameter monitor 

– Intended to be used with a parent device (multi- parameter monitor)

– Intended to supplement the multi-parameter 

monitor to display oxygen saturation but does not 

change its intended use

 The pulse oximeter is an accessory to the multi- parameter monitor
21

2. Risk of accessory and necessary 

regulatory controls?

a. Is it a new type of accessory? Yes if:

– Not classified by an existing classification 

regulation

– Not cleared in a 510(k)

– Not approved in a PMA 

New intended use for an already cleared/approved 

accessory may be considered a new type of 

accessory 

If it is not a new type of accessory, current options 

are to request reclassification under 513(e) or 

513(f)(3) 
22

2. Risk of accessory and necessary 

regulatory controls?

If it is a new type of accessory, assess eligibility for 

class I or II classification via de novo request:

a. Does the accessory pose low-moderate risk? 

b. Can general controls or general and special 

controls provide a reasonable assurance of 

safety and effectiveness?
23

Key Take-Aways

• FDA is taking a risk-based approach to classifying 

accessories when used as intended with a parent 

device 

– New types of accessories can be a lower classification 

than the parent device

– FDA encourages manufacturers to use the de novo

process to request risk-based classification of new types 

of accessories 

• The final Accessories Guidance provides 

clarification on the definition of a medical device 

accessory 
24

Additional Information

• Information on device determination:

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

Guidance/Overview/ClassifyYourDevice/ucm051521.htm 

• Unsure if your device is a new type of accessory?

– Contact the relevant review division

• Inquiries about SaMD

-- digitalhealth@fda.hhs.gov

• General Inquiries

– Division of Industry and Consumer Education: 

DICE@fda.hhs.gov
25

Panel Discussion

• Angela Krueger, Deputy Director, Office of Device 

Evaluation (Acting)

• Scott McFarland, Associate Director, Office of In 

Vitro Diagnostics and Radiological Health

• Bakul Patel, Associate Director for Digital Health

• Jonette Foy, Associate Director for Policy (Acting)

• Erica Takai, Assistant Director for Guidance 

Management
Questions?

Slide Presentation, Transcript and 

Webinar Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading ‘How to Study and 

Market Your Device

Classification’