Device Registration and Listing:

An Introduction – Part 1

Elias Mallis

Director

Division of Industry and Consumer Education

Office of Communication Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration
2
Device Registration and Listing 

Introduction

• Part 1:

– What, Why, and Who is involved with registration and listing

• Part 2:

– How to register and list

3
Learning Objectives

• Discuss background and key terms involved with 

device registration and listing

• Answer question: “Am I required to register and list?”

• Identify when you must register and list

4
Device Registration and Listing:

Background, Definitions and Terms

5
What is Registration and Listing?

• Registration:

– Informs FDA where an establishment is located

• Listing:

– Informs FDA of activity that the establishment is performing 

on the medical device

6
Registration and Listing Definitions

• Commercial Distribution:

– any distribution of a device intended for human use 

which is held or offered for sale 

21 Code of Federal Regulations (CFR), 807.3(b)

Scan Me 7
Registration and Listing Definitions

• Establishment:

– place of business

– under one management at one general physical location

– at which a device is manufactured, assembled, or 

otherwise processed

21 CFR 807.3(c)

Scan Me 8
Registration and Listing Terms

• General Controls

– Regulatory requirements authorized by the Federal 

Food, Drug, and Cosmetic Act

– Generally apply to all medical devices

www.fda.gov/medical-devices/overview-deviceregulation/regulatory-controls#gen

9 Scan Me
Regulatory Background

• Medical device establishments are required to:

1. register their establishment

2. list devices:

• manufactured, prepared, propagated, compounded, assembled, or 

processed

• at their establishment

• Mandates use of electronic registration and listing 

system

• Requires payment of user fees

10
Applicable Laws and Regulations

• Medical Device Amendments to Federal Food, Drug, and Cosmetic 

Act, Section 510

• Food and Drug Administration Amendments Act (FDAAA)

• Food and Drug Administration Safety and Innovation Act (FDASIA)

• 21 Code of Federal Regulations (CFR) Part 807

www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807

Scan Me 11
A Few Important Disclaimers

1. Registration does not, in any way, indicate 

approval or clearance of establishments or 

products per 21 CFR 807.39

2. FDA does not provide registration and listing 

“certificates”

12
Am I Required

to Register and List?

13
Establishment Location

• Domestic Establishment 

– Physical location in the United States

• Foreign Establishment

– Physical location outside the United States

14
Domestic Establishments

Required to Register

15
Domestic Establishments

Required to Register • Manufacturer (including Kit Assembler)

– of accessories or components ready for use

– of export only devices

– of custom devices

• Remanufacturer

• Specification developer

• Contract manufacturer and contract sterilizer

• Repackager

• Relabeler

• Reprocessor of single-use devices

• Complaint File establishment

• Initial importer

16
Domestic Establishments

Required to Register

• Manufacturer

– Makes by chemical, physical, biological, or other procedures

– Any article that meets definition of a device

• See 201(h) of the Federal Food, Drug, and Cosmetic Act

– Include Kit Assembler

17

Scan Me
Domestic Establishments

• Kit Assembler

– Places another establishment’s finished device into a kit

– Can’t modify device or change intended use

– Registers as either “manufacturer” or “contract 

manufacturer” based on activity

18
Domestic Establishments

Required to Register

• Manufacturer of Accessories or Components Ready for Use

– Packages or labels the product ready to be used for “health related 

purposes” to end user

• Manufacturer of Export Only Devices

– Manufactures devices not sold in U.S.; solely for export to foreign 

countries

• Manufacturer of Custom Devices

www.fda.gov/regulatory-information/search-fda-guidancedocuments/custom-device-exemption

Scan Me 19
Domestic Establishments

Required to Register

• Remanufacturer

– processes, conditions, renovates, repackages, restores, or 

does any other act to a finished device

– that significantly changes its performance, safety 

specifications, or intended use

21 CFR 820.3(w)

Scan Me 20
Domestic Establishments

Required to Register

• Specification Developer

– Develops specifications for device distributed under 

establishment’s own name

– Performs no manufacturing

– Uses contract manufacturer to make finished device

21
Domestic Establishments

Required to Register

• Contract Manufacturer and Contract Sterilizer

– Sterilizes, or otherwise makes a device for or on behalf 

of a specification developer or any other person

– Arranges manufacturing for another establishment

22
Domestic Establishments

Required to Register

• Repackager

– Packages finished devices from bulk or 

– Repackages devices made by manufacturer into 

different containers

– Excludes shipping containers

– Can’t modify device or change intended use

23
Domestic Establishments

Required to Register

• Relabeler

– Changes content of labeling from original 

manufacturer

– Distributes under establishment’s own name

– Doesn’t include establishments that merely/only add 

their own name

24
Domestic Establishments

Required to Register

• Reprocessor of a Single-Use Device

– Modifies single-use device for more than one use

– Previously used on a patient

– Has responsibility for device

• Complaint File Establishment

– Maintain complaint files according to 21 CFR 820.198

25
Domestic Establishments

Required to Register

• Initial Importer

– Further markets device from a foreign manufacturer

• To person who makes final sale to user/consumer

– Doesn’t repackage or change container, wrapper, or 

labeling

26

21 CFR 807.3(g)

Scan Me
Foreign Establishments

Required to Register

27
Foreign Establishments

Required to Register

• Manufacturer (including kit assemblers)

• Remanufacturer

• Specification developer

• Contract manufacturer and contract sterilizer

• Repackager

• Relabeler

• Reprocessor of single-use devices

• Complaint file establishment

 Similar to Domestic Establishments

28
Foreign Establishments

Required to Register

• Foreign Exporter

– Exports (or Offer for Export) to the United States

– Device manufactured, prepared, propagated, compounded, or processed in 

a foreign country

– Includes those originally manufactured in the United States

– Must have an establishment address outside the United States

• Private Label Distributor

– Exports device manufactured and owned by another party 

– Under own name and under a private label agreement

29
Who is Exempted from

Registration and Listing?

30
Establishments

Exempted from Registration

1. Component Manufacturer

– Provides raw materials or components used in device manufacture or 

assembly (not ready for use)

– Provides only to finished device manufacturer

2. Manufacturer of devices used solely for veterinary purposes

– FDA’s Center for Veterinary Medicine (CVM) regulates veterinary use 

only devices

3. Licensed Practitioner

– Manufactures or otherwise alter devices solely for use in own practice

– May not distribute device to other practitioners

31
Establishments

Exempted from Registration

4. Installer

– By manufacturer’s agent

– By user

5. Domestic Distributor

32
Establishments

Exempted from Registration

6. Retail Establishment

– Provides device directly to end users

– Includes pharmacies and surgical supply outlets

– Note: If devices come from foreign establishments, ensure 

shipment is labeled as required

33
Establishments

Exempted from Registration

7. Manufacturer of research use only devices

– Labeled device as required and used solely for research, 

teaching or analysis

– Not introduced into commercial distribution

– Only applies to domestic establishment

34
Who Must Register, Summary

• Who Must Register (Device Advice)

– Domestic or Foreign

– Definitions

– Regulatory citation

www.fda.gov/medical-devices/deviceregistration-and-listing/who-must-register-listand-pay-fee

Scan Me 35
When Do I Register and List?

36
When to Register/List:

It Depends!

• Is this your first time (Initial)?

OR

• Is this not your first time (Annual)?

37
Initial Registration and Listing

• Domestic Establishment

– Within 30 days of placing device into commercial distribution

• Foreign Establishment

– Prior to importing device to United States for first time*

• Initial Importer

– Prior to importing device to United States for first time*

– Only register; do not list device

– Identify manufacturer of each imported device

*If not done, FDA work with Customs and Border Patrol to detain and hold shipment

38
Annual Registration and Listing

• Must review registration information

– Complete annually, between October 1 – December 31 of each year

– Submit any changes necessary

• Must review listing information

– Review annually, between October 1 – December 31 of each year

– Submit any necessary changes

• May update information at any time

39
Annual Registration and Listing

• FDA recommends registration be deactivated

– If establishment discontinues marketing and 

distributing its device

40
Resources

Slide 

Number

Cited 

Resource

URL QR Code

7 21 CFR 807.3(b) www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part807/subpart-A/section-807.3#p-807.3(b)

8 21 CFR 807.3(c) www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part807/subpart-A/section-807.3#p-807.3(c)

9 General Controls 

(Device Advice)

www.fda.gov/medical-devices/overview-deviceregulation/regulatory-controls#gen

11 Code of Federal 

Regulations, Part 

807

www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807

17 201(h) of Food, 

Drug and 

Cosmetic Act

uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-

section321&num=0&edition=prelim

41
Resources

Slide 

Number

Cited Resource URL QR Code

19 Custom Device 

Exemption (FDA 

Guidance)

www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/custom-device-exemption

20 21 CFR 820.3(w) www.ecfr.gov/current/title-21/chapterI/subchapter-H/part-820#p-820.3(w)

26 21 CFR 807.3(g) www.ecfr.gov/current/title-21/chapterI/subchapter-H/part-807/subpartA/section-807.3#p-807.3(g)

35 Who Must Register, 

List and Pay the Fee

www.fda.gov/medical-devices/deviceregistration-and-listing/who-mustregister-list-and-pay-fee

42
Summary

• Registration and listing is a general control that 

applies to medical devices

• Different establishments types are required to 

register and list

• Registration and listing is required at time of initial 

distribution and, subsequently, on an annual basis

43
Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 200 modules - videos, webinars, presentations, software-based “how to” modules

 accessible on your portable devices: www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information across the device total product life cycle: 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Email: DICE@fda.hhs.gov

 Phone: 1-800-638-2041 or (301) 796-7100 (Live Agents 9 am – 12:30 pm; 1 – 4: 30 pm ET)

CDRH Learn

Scan Me

Device Advice

Scan Me

Email DICE

Scan Me 44
Your Call To Action

• Identify your type of establishment and determine 

whether you need to register and list

• If you must register and list, watch Part 2 of this 

Introduction on CDRH Learn

45