21 CFR Part 80

Medical Devices; Repo

Corrections and Remo

21 CFR Part 80

Medical Devices; Repo

Corrections and Remo

Kenneth C. Millen

Lead Compliance Officer

Division of Enforcement A

Office of Compliance

Kenneth C. Millen

Lead Compliance Officer

Division of Enforcement A

Office of Compliance

21 CFR Part 80

21 CFR Part 80

Medical Devices; Repo

Corrections and Rem

Medical Devices; Repo

Corrections and Rem

Kenneth C. Millen

Lead Compliance Office

Division of Enforcement 

Office of Compliance

Kenneth C. Millen

Lead Compliance Office

Division of Enforcement 

Office of Compliance
Recall Reporting Requi

Recall Reporting Requi

 Objective

 To review the requirements fo

medical device corrections anto FDA. 

 Objective Objective

 To review the requirements fo

To review the requirements fo

medical device corrections an

medical device corrections an

to FDA.
Contents Contents

 Scope of 21 CFR 806  When to Report Who must Report Why Reporting is required What must be Reported How to Report Additional Questions

 Expansion of Corrections and Removals Liability Records Public Disclosure

 Scope of 21 CFR 806 Scope of 21 CFR 806  When to Report When to Report Who must Report Who must Report Why Reporting is required Why Reporting is required What must be Reported What must be Reported How to Report How to Report Additional Questions Additional Questions

 Expansion of Corrections and Removals Expansion of Corrections and Removals Liability Liability Records Records Public Disclosure Public Disclosure
Requirements und

21 CFR 806 

Requirements und

Requirements und

21 CFR 806 21 CFR 806

 21 CFR 806.1 - Scope

 Section 519(f) of the Federal 

and Cosmetic Act (the act) redevice manufacturers and impreport promptly 

(within 10 w

days of initiation) to the FoDrug Administration (FDA) ceconcerning device corrections removals, 

 21 CFR 806.1 21 CFR 806.1 - 

- Scope

 Section 519(f) of the Federal 

Section 519(f) of the Federal 

and Cosmetic Act (the act) re

and Cosmetic Act (the act) re

device manufacturers and imp

device manufacturers and imp

report promptly promptly

(within 10 w

within 10 w

days of initiation days of initiation) to the Fo

) to the Fo

Drug Administration (FDA) ce

Drug Administration (FDA) ce

concerning device corrections 

concerning device corrections 

removals, removals, 
Requirements und

21 CFR 806 

Requirements und

Requirements und

21 CFR 806 21 CFR 806

 21 CFR 806.1 cont’d

 and to maintain records of 

corrections and removals rof whether such correctionremovals are required to bto FDA. 

 21 CFR 806.1 cont 21 CFR 806.1 cont’

d

 andto maintain records of 

to maintain records of 

corrections and removals r

corrections and removals r

of whether such correction

of whether such correction

removals are required to b

removals are required to b

to FDA. to FDA.
When Do We Have to R

Correction or Removal 

WhenDo We Have to R

Do We Have to R

Correction or Removal 

Correction or Removal 

 21 CFR 806.10(b)

 The manufacturer or importer 

submit any required report wworking (business) days of incorrection or removal. 

WITHIN 10 BUSINES

 21 CFR 806.10(b) 21 CFR 806.10(b)

 The manufacturer or importer 

The manufacturer or importer 

submit any required report wi

submit any required report w

working (business) days of in

working (business) days of in

correction or removal. correction or removal.

WITHIN 10 BUSINES

WITHIN 10 BUSINES
Who Must Report Corr

and Removals to F

WhoMust Report Corr

Must Report Corr

and Removals to F

and Removals to F

 All Manufacturers and Im

are required to report corand removals to FDA. 

 All Manufacturers Manufacturers and Im

Im

are required to report cor

are required to report cor

and removals to FDA. and removals to FDA.
Who Must Report Corr

and Removals to F

WhoMust Report Corr

Must Report Corr

and Removals to F

and Removals to F

 Manufacturer 

–

Any person who manufactures, prep

propagates, compounds, assembles, a device by chemical, physical, biologprocedures. The term includes any p

(1) Repackages or otherwise change

container, wrapper, or labeling of furtherance of the distribution of tfrom the original place of manufacperson who makes final delivery oultimate user or consumer; or 

 Manufacturer Manufacturer

–

Any person who manufactures, prep

Any person who manufactures, prep

propagates, compounds, assembles, 

propagates, compounds, assembles, 

a device by chemical, physical, biolog

a device by chemical, physical, biolog

procedures. The term includes any p

procedures. The term includes any p

(1) Repackages or otherwise change

(1) Repackages or otherwise change

container, wrapper, or labeling of 

container, wrapper, or labeling of 

furtherance of the distribution of t

furtherance of the distribution of t

from the original place of manufac

from the original place of manufac

person who makes final delivery o

person who makes final delivery o

ultimate user or consumer; ultimate user or consumer; or
Who Must Report Corr

and Removals to F

WhoMust Report Corr

Must Report Corr

and Removals to F

and Removals to F

 Manufacturer –

(2) Initiates specifications for d

are manufactured by a second subsequent distribution by the initiating the specifications; o

 Manufacturer Manufacturer –

(2) Initiates specifications for d

(2) Initiates specifications for d

are manufactured by a second 

are manufactured by a secon

subsequent distribution by the 

subsequent distribution by the 

initiating the specifications; initiating the specifications; or
Who Must Report Corr

and Removals to F

WhoMust Report Corr

Must Report Corr

and Removals to F

and Removals to F

 Manufacturer 

–

(3) Manufactures components o

accessories which are devices ready to be used and are intecommercially distributed and intended to be used as is, or processed by a licensed practother qualified person to meeof a particular patient. 

 Manufacturer Manufacturer

–

(3) Manufactures components o

(3) Manufactures components o

accessories which are devices 

accessories which are devices 

ready to be used and are inte

ready to be used and are inte

commercially distributed and 

commercially distributed and 

intended to be used as is, or 

intended to be used as is, or 

processed by a licensed pract

processed by a licensed pract

other qualified person to mee

other qualified person to mee

of a particular patient. of a particular patient.
Who Must Report Corr

and Removals to F

WhoMust Report Corr

Must Report Corr

and Removals to F

and Removals to F

 Importer –

For the purposes of 21 CFR 

importer is any person who medical device into the Uni

 Importer Importer –

For the purposes of 21 CFR 

For the purposes of 21 CFR 

importer is any person who 

importer is any person who 

medical device into the Uni

medical device into the Uni
Who Must Report Corr

and Removals to F

WhoMust Report Corr

Must Report Corr

and Removals to F

and Removals to F

 21 CFR 806.10(a)

 Each device manufacturer or 

shall submit a written report tdistrict office of any correction of a device initiated by such manufacturer or importer if thor removal was initiated: 

 21 CFR 806.10(a) 21 CFR 806.10(a)

 Each device manufacturer or 

Each device manufacturer or 

shall submit a written report t

shall submit a written report t

district office of any correction 

district office of any correctio

of a device initiated by such of a device initiated by such manufacturer or importer if th

manufacturer or importer if th

or removal was initiated: or removal was initiated:
Who Must Report Corr

and Removals to F

WhoMust Report Corr

Must Report Corr

and Removals to F

and Removals to F

 21 CFR 806.10(a)(1) and 

1. To reduce a risk to health po

device; or 

2. To remedy a violation of the 

by the device which may preto health 

 21 CFR 806.10(a)(1) and 

21 CFR 806.10(a)(1) and 

1.To reduce a risk to health po

To reduce a risk to health po

device; or device; or

2.To remedy a violation of the 

To remedy a violation of the 

by the device which may pre

by the device which may pre

to health to health
What Must We Includ

Report? 

WhatMust We Include 

Must We Includ

Report? Report?

1. Correction or Removal Report N2. Manufacturer or Importer Infor3. Device Identification4. Marketing Status5. Model6. Manufacturer Information7. Event Description8. Illnesses or Injuries

1.Correction or Removal Report N

Correction or Removal Report N

2.Manufacturer or Importer Infor

Manufacturer or Importer Infor

3.Device Identification Device Identification4.Marketing Status Marketing Status5.Model6.Manufacturer Information Manufacturer Information7.Event Description Event Description8.Illnesses or Injuries Illnesses or Injuries
What Must We Incl

the Report? 

What Must We Incl

the Report? the Report?

6. Quantities7. Date of Manufacture and Distri8. Consignees9. Communications10.Statement if missing any above 

6.Quantities Quantities

7.Date of Manufacture and Distrib

Date of Manufacture and Distri

8.Consignees Consignees9.Communications Communications10.Statement if missing any above 

Statement if missing any above 
1. Report Numb

1. Report Numb

 21 CFR 806.10(C)(1)

 The seven digit registration n

the entity responsible for subthe report of corrective or rem(if applicable), the month, daythat the report is made, and a number (i.e., 001 for the first for the second report, 003 etcreport type designation "C" or 

 21 CFR 806.10(C)(1) 21 CFR 806.10(C)(1)

 The seven digit registration n

The seven digit registration n

the entity responsible for sub

the entity responsible for sub

the report of corrective or rem

the report of corrective or rem

(if applicable), the month, day

(if applicable), the month, day

that the report is made, and a 

that the report is made, and a 

number (i.e., 001 for the first 

number (i.e., 001 for the first 

for the second report, 003 etc

for the second report, 003 etc

report type designation "C" or 

report type designation "C" o
1. Report Numb

1. Report Numb

 Report Numbers must be 

format: 

1234567-MM/DD/YYYY-001

Registration # Date Report C = CorrectionR = Removal

 Report Numbers must be 

Report Numbers must be 

format: format:

1234567 1234567

-MM/DD/YYYY MM/DD/YYYY

-001

Registration # Date Report 

Registration # Date Report 

C = Correction C = CorrectionR = Removal R = Removal
1. Report Numb

1. Report Numb

 If your firm does not have 

Registration Number, entzeros in place of the RegiNumber, like this: 

0000000-MM/DD/YYYY-001

 If your firm does not have 

If your firm does not hav

Registration Number, ent

Registration Number, ent

zeros in place of the Regi

zeros in place of the Regi

Number, like this: Number, like this:

0000000 0000000-MM/DD/YYYY MM/DD/YYYY

-001
1. Report Numb

1. Report Numb

 If your firm submits more than o

FDA, change the report number how many reports have been suthis: 

Removal 1 – 1234567-MM/DD/YYYYRemoval 2 – 1234567-MM/DD/YYYYCorrection 1 – 1234567-MM/DD/YYYCorrection 2 – 1234567-MM/DD/YYY

 If your firm submits more than o

If your firm submits more than o

FDA, change the report number 

FDA, change the report number 

how many reports have been su

how many reports have been su

this:

Removal 1 Removal 1 – 

– 1234567 1234567

-MM/DD/YYYY MM/DD/YYYY

Removal 2 Removal 2 –1234567 1234567

-MM/DD/YYYY MM/DD/YYYY

Correction 1 Correction 1 –1234567 1234567

-MM/DD/YYY

MM/DD/YYY

Correction 2 Correction 2 – 

– 1234567 1234567

-MM/DD/YYY

MM/DD/YYY
2. Manufacturer or Im

Information 

2. Manufacturer or Im

2. Manufacturer or Im

Information Information

 21 CFR 806.10(C)(2)

 The report should contain the 

address, and telephone numbmanufacturer or importer, and title, address, and telephone the manufacturer or importer representative responsible for the device correction or remo

 21 CFR 806.10(C)(2) 21 CFR 806.10(C)(2)

 The report should contain the 

The report should contain the 

address, and telephone numb

address, and telephone numb

manufacturer or importer, and 

manufacturer or importer, an

title, address, and telephone 

title, address, and telephone 

the manufacturer or importer the manufacturer or importer representative responsible for 

representative responsible for 

the device correction or remo

the device correction or remo
2. Manufacturer or Im

Information 

2. Manufacturer or Im

2. Manufacturer or Im

Information Information

 Like this:

Device Manufacturer, Inc123 Main StAnytown, CA 90210(949) 555-1212Firm Representative:Jane Smith, Title123 Main StAnytown, CA 90210(949) 555-1212 x 123

 Like this Like this:

Device Manufacturer, Inc Device Manufacturer, Inc123 Main St 123 Main StAnytown Anytown, CA 90210 , CA 90210

(949) 555 (949) 555-1212

Firm Representative: Firm Representative:Jane Smith, Title Jane Smith, Title123 Main St 123 Main StAnytown Anytown, CA 90210 , CA 90210

(949) 555 (949) 555-1212 x 123 1212 x 123
3. Device Identific

3. Device Identific

 21 CFR 806.10(C)(3)

 The brand name and the com

classification name, or usual ndevice and the intended use odevice. 

 21 CFR 806.10(C)(3) 21 CFR 806.10(C)(3)

 The brand name and the com

The brand name and the com

classification name, or usual n

classification name, or usual n

device and the intended use o

device and the intended use o

device. device.
3. Device Identific

3. Device Identific

 Be very specific with device na

This is not acceptable:

Name of Device: Pump, White

This is acceptable

Name of Device: XYZ Dandy PumpPump, Infusion, Implanted, Progra

 Be very specific with device na

Be very specific with device na

This is This is notacceptable: acceptable:

Name of Device: Name of Device: Pump, White Pump, White

This isacceptable acceptable

Name of Device: XYZ Dandy Pump Name of Device: XYZ Dandy PumpPump, Infusion, Implanted, Progra

Pump, Infusion, Implanted, Progra
3. Device Identific

3. Device Identific

 Be very specific with the Intend

Reflect the FDA cleared/approvIntended Use. 

This is not acceptable:

Pumps fluidThis is acceptable:Intended for use in parenteral, entepidural therapies and the adminiswhole blood and blood products.

 Be very specific with the Intend

Be very specific with the Intend

Reflect the FDA cleared/approv

Reflect the FDA cleared/approv

Intended Use. Intended Use.

This is This is notacceptable: acceptable:

Pumps fluid Pumps fluid

This isacceptable: acceptable:

Intended for use in parenteral, entepidural therapies and the adminiswhole blood and blood products.
4. Marketing Status of 

4. Marketing Status of 

 21 CFR 806.10(C)(4)

 The report should contain the 

status of the device, i.e., any premarket notification numbeapproval number, or indicatiodevice is a pre-amendments dthe device listing number. 

For Example:510(k) #: K111234PMA #: P111234

 21 CFR 806.10(C)(4) 21 CFR 806.10(C)(4)

 The report should contain the 

The report should contain the 

status of the device, i.e., any 

status of the device, i.e., any 

premarket notification numbe

premarket notification numbe

approval number, or indicatio

approval number, or indicatio

device is a pre device is a pre

-amendments d

amendments d

the device listing number. the device listing number.

For Example: For Example:510(k) #: K111234 510(k) #: K111234PMA #: P111234 PMA #: P111234
5. Model 5. Model

 21 CFR 806.10(C)(5)

 The report should contain the 

catalog, or code number of thand the manufacturing lot or number of the device or otheidentification number. 

 21 CFR 806.10(C)(5) 21 CFR 806.10(C)(5)

 The report should contain the 

The report should contain the 

catalog, or code number of th

catalog, or code number of th

and the manufacturing lot or 

and the manufacturing lot or 

number of the device or othe

number of the device or othe

identification number. identification number.
6. Manufacturer 6. Manufacturer’s N

6. Manufacturer

’s N

 21 CFR 806.10(C)(6)

 The report should contain the 

manufacturer's name, addresnumber, and contact person ifrom that of the person submreport. For example, a firm may be manufacturing at a different ssite reporting to FDA. Make ithe report who is recalling anmanufacturing 

 21 CFR 806.10(C)(6) 21 CFR 806.10(C)(6)

 The report should contain the The report should contain the manufacturer's name, address

manufacturer's name, addres

number, and contact person number, and contact person i

i

from that of the person subm

from that of the person subm

report. report. For example, a firm may be For example, a firm may be manufacturing at a different s

manufacturing at a different s

site reporting to FDA. Make i

site reporting to FDA. Make i

the report who is recalling an

the report who is recalling an

manufacturing manufacturing
6. Manufacturer 6. Manufacturer’s N

6. Manufacturer

’s N

For Example:Recalling FirmDevice Recaller, Inc123 Main StAnytown, CA 90210(949) 555-1212ManufacturerDevice Manufacturer, Inc123 Stone AveDevicetown, FL 33756(800) 555-1212

For Example: For Example:Recalling Firm Recalling Firm

Device Recaller Recaller, Inc

123 Main St 123 Main StAnytown Anytown, CA 90210 , CA 90210(949) 555 (949) 555-1212

Manufacturer Manufacturer

Device Manufacturer, Inc Device Manufacturer, Inc123 Stone Ave 123 Stone AveDevicetown Devicetown, FL 33756 , FL 33756(800) 555 (800) 555-1212
7. Event Descript

7. Event Descript

 21 CFR 806.10(C)(7)

 The report should contain a d

the event(s) giving rise to the reported and the corrective o

actions that have been, and ato be taken. 

 Include as much relevant info

possible, be clear in terms of been done as well as what wi

 21 CFR 806.10(C)(7) 21 CFR 806.10(C)(7)

 The report should contain a d

The report should contain a d

the event(s event(s) giving rise to the 

) giving rise to the 

reported reported andthe corrective o

the corrective o

actions that have been, and a

actions that have been, and a

to be taken. to be taken.

 Include as much relevant info

Include as much relevant info

possible, be clear in terms of 

possible, be clear in terms of 

been done as well as what done as well as what wi
8. Illnesses or Inju

8. Illnesses or Inju

 21 CFR 806.10(C)(8)

 The report should contain info

about any illness or injuries awith the use of the device. If identify any Medical Device R(MDRs) submitted to FDA for illnesses or injuries. 

 21 CFR 806.10(C)(8) 21 CFR 806.10(C)(8)

 The report should contain info

The report should contain info

about any illness or injuries a

about any illness or injuries a

with the use of the device. If 

with the use of the device. If 

identify any Medical Device R

identify any Medical Device R

(MDRs) submitted to FDA for 

(MDRs) submitted to FDA for 

illnesses or injuries. illnesses or injuries.
9. Quantity of Dev

9. Quantity of Dev

 21 CFR 806.10(C)(9)

 The total number of devices 

manufactured or distributed sthe correction or removal and 

number in the same batch, lo

equivalent unit of production the correction or removal. 

 21 CFR 806.10(C)(9) 21 CFR 806.10(C)(9)

 The totalnumber of devices number of devices 

manufactured or distributed s

manufactured or distributed s

the correction or removal the correction or removal and 

and 

numberin the same batch, lo

in the same batch, lo

equivalent unit of production 

equivalent unit of production 

the correction or removal. the correction or removal.
9. Quantity of Dev

9. Quantity of Dev

For Example: 

Total Qty Manufactured: 1,000 Pu

Lot 1 – 250Lot 2 – 250Lot 3 – 250Lot 4 – 250

Please also include the number dTotal Qty Distributed: Lots 1 and 

Pumps 

For Example For Example: 

Total Qty Manufactured: 1,000 Pu

Total Qty Manufactured: 1,000 Pu

Lot 1 –250

Lot 2 –250

Lot 3 –250

Lot 4 –250

Please also include the number d

Please also include the number d

Total Qty Distributed: Lots 1 and 

Total Qty Distributed: Lots 1 and 

Pumps
10. Date of Manufact

Distribution 

10. Date of Manufact

10. Date of Manufact

Distribution Distribution

 21 CFR 806.10(C)(10)

 The report should contain the 

manufacture or distribution an

device's expiration date or ex

For Example:

Manufactured 01/01/2013 – Expiration date – 4 years fromanufacture

 21 CFR 806.10(C)(10) 21 CFR 806.10(C)(10)

 The report should contain the 

The report should contain the 

manufacture or distribution manufacture or distribution an

device's expiration date or ex

device's expiration date or ex

For Example For Example:

Manufactured 01/01/2013 Manufactured 01/01/2013 – 

– 

Expiration date Expiration date –4 years fro

4 years fro

manufacture manufacture
11. Consignee

11. Consignee

 21 CFR 806.10(C)(11)

 Your report should contain th

addresses, and telephone numdomestic and foreign consigndevice and the dates and numdevices distributed to each suconsignee NOTE: This data should be accurate contact these consignees to determineffectiveness. 

 21 CFR 806.10(C)(11) 21 CFR 806.10(C)(11)

 Your report should contain th

Your report should contain th

addresses, and telephone num

addresses, and telephone num

domestic and foreign consign

domestic and foreign consign

device and the dates and num

device and the dates and num

devices distributed to each su

devices distributed to each su

consignee consignee 

NOTE: This data should be accurate 

NOTE: This data should be accurate 

contact these consignees to contact these consignees to determin

determin

effectiveness. effectiveness.
12. Communicati

12. Communicati

 21 CFR 806.10(C)(12)

 Your report should contain a 

communications regarding the or removal and the names anof all recipients of the communot provided in accordance wparagraph (c)(11) of this sectNOTE: If the recall is potentially a Clcontact FDA District Recall Coordinatpossible to provide your report and cnotification strategy/letter. 

 21 CFR 806.10(C)(12) 21 CFR 806.10(C)(12)

 Your report should contain a c

Your report should contain a 

communications regarding the 

communications regarding the 

or removal and the names an

or removal and the names an

of all recipients of the commu

of all recipients of the commu

not provided in accordance w

not provided in accordance w

paragraph (c)(11) of this sect

paragraph (c)(11) of this sect

NOTE: If the recall is potentially a Cl

NOTE: If the recall is potentially a Cl

contact FDA District Recall Coordinat

contact FDA District Recall Coordinat

possible to provide your report and c

possible to provide your report and c

notification strategy/letter. notification strategy/letter.
13. Missing Informa

13. Missing Informa

 21 CFR 806.10(C)(13)

 If any required information is n

immediately available, you shoa statement to FDA as to why available and when it will be suNOTE: FDA takes recalls very serious

follow up with firms submitting incominformation; possibly taking Regulatoagainst the firm if necessary. These include Warning Letters, Untitled LetMoney Penalties, etc. 

 21 CFR 806.10(C)(13) 21 CFR 806.10(C)(13)

 If any required information is n

If any required information is n

immediately available, you sho

immediately available, you sho

a statement to FDA as to why 

a statement to FDA as to why 

available and when it will be su

available and when it will be su

NOTE: FDA takes recalls NOTE: FDA takes recalls veryserious

serious

follow up with firms submitting incom

follow up with firms submitting incom

information; possibly taking Regulato

information; possibly taking Regulato

against the firm if nece against the firm if necessary. These 

ssary. These 

include Warning Letters, Untitled Let

include Warning Letters, Untitled Let

Money Penalties, etc. Money Penalties, etc. 
Requirements under 

806 

Requirements under 2

Requirements under 

806

 21 CFR 806.10(f)

 No report of correction or remov

under this part, if a report of the removal is required and has been under parts 803 – Medical Device or 1004 – Repurchase, Repairs, oReplacement of Electronic Produ

 21 CFR 806.10(f) 21 CFR 806.10(f)

 No report of correction or remov

No report of correction or remov

under this part, if a report of the 

under this part, if a report of the 

removal is required and has been 

removal is required and has been 

under parts 803 under parts 803 – 

– Medical Device 

Medical Device 

or 1004 or 1004 –Repurchase, Repairs, o

Repurchase, Repairs, o

Replacement of Electronic Produc

Replacement of Electronic Produ
How do We Repor

Correction or Removal 

How do We Repor

How do We Repor

Correction or Removal 

Correction or Removal 

 21 CFR 7.46

 You are requested to report correction

your FDA District Recall Coordinator as possible. 

 21 CFR 806.10(b)

 Remember, you are required to report 

business days after initiating such corr

removal. 

 You may find your recall coordinato

www.fda.gov

/

Safety/Recalls/Industry

Guidance/ucm

 21 CFR 7.46 21 CFR 7.46

 You are requested to report correction

You are requested to report correction

your FDA District Recall Coordinator as 

your FDA District Recall Coordinator as 

possible. possible.

 21 CFR 806.10(b) 21 CFR 806.10(b)

 Remember, you are required to report 

Remember, you are required to report 

business days business days after initiating such corr

after initiating such corr

removal. removal.

 You may find your recall coordinato

You may find your recall coordinato

www.fda.gov www.fda.gov

/

Safety/Recalls/Industry ndustry

Guidance uidance/ucm

/ucm
Failure to Comp

Failure to Comp

 SEC. 502.(t) (21 U.S.C. 352)

 A device shall be deemed to be m

 If it is a device and there was a fail

 to comply with any requirement presc

518 – [Notification], 

 to furnish any material or information 

under section 519 – [General Rule of RReports on Devices] – or 

 to comply with a requirement under se

[Postmarket Surveillance]. 

 SEC. 502.(t) (21 U.S.C. 352) SEC. 502.(t) (21 U.S.C. 352)

 A device shall be deemed to be m

A device shall be deemed to be m

 If it is a device and there was a fail

If it is a device and there was a fail

 to comply with any requirement presc

to comply with any requirement presc

518 –[Notification], [Notification],

 to furnish any material or information 

to furnish any material or information 

under section 519 under section 519 –[General Rule of R

[General Rule of R

Reports on Devices] Reports on Devices] –or 

 to comply with a requirement under se

to comply with a requirement under se

[Postmarket Surveillance]. [Postmarket Surveillance].
Additional Quest

Additional Quest

 Expansion of correction or re Liability Records Public Disclosure

 Expansion of correction or re

Expansion of correction or re

 Liability Liability Records Records Public Disclosure Public Disclosure
What if We Expand 

Correction or Remo

What if We Expand 

What if We Expand 

Correction or Remo

Correction or Remo

 If, after submitting a report un

part, a manufacturer or importdetermines that the same correremoval should be extended to lots or batches of the same device................................ 

 If, after submitting a report un

If, after submitting a report un

part, a manufacturer or import

part, a manufacturer or import

determines that the same corre

determines that the same corre

removal should be extended to 

removal should be extended to 

lots or batches of the same lots or batches of the same device.............................. ................................
What if We Expand 

Correction or Remo

What if We Expand 

What if We Expand 

Correction or Remo

Correction or Remo

 ....................the manufacturer 

shall within 10-working (busine

initiating the extension of the cremoval, amend the report by an amendment citing the originnumber. 

 ....................the manufacturer o

..the manufacturer 

shall within 10 within 10-working (busine

working (busine

initiating the extension of the c

initiating the extension of the c

removal, amend the report by 

removal, amend the report by 

an amendment citing the origin

an amendment citing the origin

number. number. 
What if We Expand 

Correction or Remo

What if We Expand 

What if We Expand 

Correction or Remo

Correction or Remo

 Your report for the expansion 

original recall should contain: 

1. The original report number2. All contact information for th

manufacturer or importer as under 21 CFR 806.10(c)(2) 

3. Any other information that d

the original report 

 Your report for the expansion 

Your report for the expansion 

original recall should contain: original recall should contain:

1.The original report number The original report number

2.All contact information for th

All contact information for th

manufacturer or importer as 

manufacturer or importer as 

under 21 CFR 806.10(c)(2) under 21 CFR 806.10(c)(2)

3.Anyother information that d

other information that d

the original report the original report
Are We Admitting Lia

Are We Admitting Lia

 A report submitted by a manuf

importer under this section (anrelease by FDA of that report oinformation) does not necessarconclusion by the manufactureor FDA that the report or informconstitutes an admission that tcaused or contributed to a deaserious injury. 

 A report submitted by a manuf

A report submitted by a manuf

importer under this section (an

importer under this section (an

release by FDA of that report o

release by FDA of that report o

information) does not necessar

information) does not necessar

conclusion by the manufacture

conclusion by the manufacture

or FDA that the report or inform

or FDA that the report or inform

constitutes an admission that t

constitutes an admission that t

caused or contributed to a dea

caused or contributed to a dea

serious injury. serious injury. 
Are We Admitting Lia

Are We Admitting Lia

 A manufacturer or importer ne

admit, and may deny, that the information submitted under thconstitutes an admission that tcaused or contributed to a deaserious injury. 

 A manufacturer or importer ne

A manufacturer or importer ne

admit, and may deny, that the 

admit, and may deny, that the 

information submitted under th

information submitted under th

constitutes an admission that t

constitutes an admission that t

caused or contributed to a dea

caused or contributed to a dea

serious injury. serious injury. 
Exemptions from 21 C

Requirements 

Exemptions from 21 C

Exemptions from 21 C

Requirements Requirements

 21 CFR 806.1 cont’d

 There are certain actions w

exempt from the Reportin

requirements under 806 

 21 CFR 806.1 cont 21 CFR 806.1 cont’

d

 There are certain actions w

There are certain actions w

exemptfrom the Reporting from the Reportin

requirements under 806 requirements under 806
Exemptions from 21 C

Requirements 

Exemptions from 21 C

Exemptions from 21 C

Requirements Requirements

 Exemptions

1. Changes which improve qua

not reduce a risk to health oviolation 

2. Market Withdrawals3. Routine Servicing4. Stock Recoveries 

 Exemptions Exemptions

1.Changes which improve qua

Changes which improve qua

not reduce a risk to health o

not reduce a risk to health o

violation violation 

2.Market Withdrawals Market Withdrawals3.Routine Servicing Routine Servicing4.Stock Recoveries Stock Recoveries 
Exemptions from 21 C

Requirements 

Exemptions from 21 C

Exemptions from 21 C

Requirements Requirements

 Exemptions

 Actions taken by device manu

importers to improve the perfquality of a device but that do a risk to health posed by the remedy a violation of the act the device 

 Exemptions Exemptions

 Actions taken by device manu

Actions taken by device manu

importers to improve the perf

importers to improve the perf

quality of a device but that do 

quality of a device but that do 

a risk to health posed by the 

a risk to health posed by the 

remedy a violation of the act 

remedy a violation of the act 

the device the device 
Exemptions from 21 C

Requirements 

Exemptions from 21 C

Exemptions from 21 C

Requirements Requirements

 Exemptions

 Market Withdrawals -

A Market Withdrawal is a corr

removal of a distributed devicinvolves a minor violation of twould not be subject to legal FDA or that involves no violat

act, e.g., normal stock rotatio

 Exemptions Exemptions

 Market Withdrawals Market Withdrawals 

-

A Market Withdrawal is a corr

A Market Withdrawal is a corr

removal of a distributed devic

removal of a distributed devic

involves a minor violation of t

involves a minor violation of t

would not be subject to legal 

would not be subject to legal 

FDA orthat involves no violat

that involves no violat

act, e.g., normal stock rotatio

act, e.g., normal stock rotatio
Exemptions from 21 C

Requirements 

Exemptions from 21 C

Exemptions from 21 C

Requirements Requirements

 Exemptions

 Routine Servicing -

Any regularly scheduled maindevice, including the replacemat the end of their normal life expectancy, e.g., calibration, of batteries, and responses to wear and tear. Repairs of an nature, replacement of parts their normal life expectancy, orepairs or replacements of muof a device are not routine se

 Exemptions Exemptions

 Routine Servicing Routine Servicing 

-

Any regularly scheduled main

Any regularly scheduled main

device, including the replacem

device, including the replacem

at the end of their normal life at the end of their normal life expectancy, e.g., calibration, 

expectancy, e.g., calibration, 

of batteries, and responses to 

of batteries, and responses to 

wear and tear. Repairs of an 

wear and tear. Repairs of an 

nature, replacement of parts 

nature, replacement of parts 

their normal life expectancy, o

their normal life expectancy, o

repairs or replacements of mu

repairs or replacements of mu

of a device are not routine se

of a device are not routine se
Exemptions from 21 C

Requirements 

Exemptions from 21 C

Exemptions from 21 C

Requirements Requirements

 Exemptions

 Stock Recoveries -

The correction or removal of a dthat has not been marketed or tnot left the direct control of the manufacturer, i.e., the device is on the premises owned, or undecontrol of, the manufacturer, anportion of the lot, model, code, relevant unit involved in the corrremoval action has been releaseor use. 

 Exemptions Exemptions

 Stock Recoveries Stock Recoveries 

-

The correction or removal of a d

The correction or removal of a d

that has not been marketed or t

that has not been marketed or t

not left the direct control of the not left the direct control of the manufacturer, i.e., the device is 

manufacturer, i.e., the device is 

on the premises owned, or unde

on the premises owned, or unde

control of, the manufacturer, an

control of, the manufacturer, an

portion of the lot, model, code, o

portion of the lot, model, code, 

relevant unit involved in the corr

relevant unit involved in the cor

removal action has been release

removal action has been release

or use. or use.
Exemptions from 21 C

Requirements 

Exemptions from 21 C

Exemptions from 21 C

Requirements Requirements

 IF IN DOUBT –

ASK YOUR DIST

RECALL 

COORDINAT

(DRC)

 IF IN DOUBT IF IN DOUBT 

–

ASK YOUR DIST

ASK YOUR DIST

RECALL 

COORDINAT

COORDINAT

(DRC)
If We Did Not Need to 

our Correction or Rem

What Records Do We 

If We Did Not Need to 

If We Did Not Need to 

our Correction or Rem

our Correction or Rem

What Records Do We 

What Records Do We 

 Each device manufacturer or im

initiates a correction or removadevice that is not required to bto FDA under 806.10 shall keep of such correction or removal. 

 Each device manufacturer or im

Each device manufacturer or im

initiates a correction or remova

initiates a correction or remova

device that is not required to b

device that is not required to b

to FDA under 806.10 shall keep 

to FDA under 806.10 shall keep 

of such correction or removal. of such correction or removal.
What Should the Re

Contain? 

What Should the Re

What Should the Re

Contain? Contain?

 Records of corrections and re

required to be reported to FD806.10 shall contain the followinformation: 

1. The brand name, common or u

classification, and product code and the intended use of the de

 Records of corrections and re

Records of corrections and re

required to be reported to FD

required to be reported to FD

806.10 shall contain the follow

806.10 shall contain the follow

information: information:

1.The brand name, common or u

The brand name, common or u

classification, and product code 

classification, and product code 

and the intended use of the de

and the intended use of the de
What Should the Re

Contain? 

What Should the Re

What Should the Re

Contain? Contain?

2. The model, catalog, or code nu

device and the manufacturing lnumber of the device or other number 

3. A description of the event(s) gi

the information reported and thor removal action that has beenexpected to be taken. 

2.The model, catalog, or code nu

The model, catalog, or code nu

device and the manufacturing l

device and the manufacturing l

number of the device or other i

number of the device or other 

number 

3.A description of the A description of the event(s event(s) gi

) gi

the information reported and th

the information reported and th

or removal action that has been

or removal action that has been

expected to be taken. expected to be taken. 
What Should the Re

Contain? 

What Should the Re

What Should the Re

Contain? Contain?

4. Justification for not reporting th

or removal action to FDA, whiccontain conclusions and any fobe reviewed and evaluated by a person. 

The justification may include a roo

5. A copy of all communications re

correction or removal. 

4.Justification for not reporting th

Justification for not reporting th

or removal action to FDA, whic

or removal action to FDA, whic

contain conclusions and any fol

contain conclusions and any fo

be reviewed and evaluated by a 

be reviewed and evaluated by a 

person. person. 

The justification may include a roo

The justification may include a roo

5.A copy of all communications re

A copy of all communications re

correction or removal. correction or removal. 
How Long Should We K

Records? 

How Long Should We K

How Long Should We K

Records? Records?

 The manufacturer or importer shall 

records required under this section of 2 years beyond the expected life device, even if the manufacturer or 

ceased to manufacture or import th

 Records required to be maintained 

paragraph (b) of this section must transferred to the new manufactureof the device and maintained for thperiod of time 

 The manufacturer or importer shall 

The manufacturer or importer shall 

records required under this section 

records required under this section 

of 2 years beyond the expected life 

2 years beyond the expected life 

device, even if the manufacturer or 

, even if the manufacturer or 

ceased to manufacture or import th

ceased to manufacture or import th

 Records required to be maintained 

Records required to be maintained 

paragraph (b) of this section must 

paragraph (b) of this section must 

transferred to the new manufacture

transferred to the new manufacture

of the device and maintained for th

of the device and maintained for th

period of time period of time 
FDA Access to Rec

FDA Access to Rec

 Each device manufacturer or im

required under this part (21 CFmaintain records and every perin charge or custody of such re

upon request of an officer or edesignated by FDA and under s704(e) of the act, permit such 

employee at all reasonable timaccess to, and to copy and verrecords and reports. 

 Each device manufacturer or im

Each device manufacturer or im

required under this part (21 CF

required under this part (21 CF

maintain records and every per

maintain records and every per

in charge or custody of such re

in charge or custody of such re

upon request of an officer or e

upon request of an officer or e

designated by FDA and under s

designated by FDA and under s

704(e) of the act, 704(e) of the act, permit such 

permit such 

employee at all reasonable tim

employee at all reasonable tim

access to, and to copy and ver

access to, and to copy and ver

records and reports records and reports.
FDA Access to Rec

FDA Access to Rec

 It is imperative that you keep a

records of any correction or remundertaken by your firm. 

 FDA can and may inspect these 

 It is imperative that you keep a

It is imperative that you keep a

records of any correction or rem

records of any correction or rem

undertaken by your firm. undertaken by your firm. 

 FDA canand mayinspect these 

inspect these 
Will FDA Make Our R

Public? 

Will FDA Make Our R

Will FDA Make Our R

Public? Public?

 Any report submitted under thi

available for public disclosure iaccordance with part 20, ChapTitle 21 of the Code of Federal Regulations. 

 Any report submitted under thi

Any report submitted under thi

available for public disclosure i

available for public disclosure i

accordance with part 20, Chap

accordance with part 20, Chap

Title 21 of the Code of Federal Title 21 of the Code of Federal Regulations. Regulations. 
Will FDA Make Our R

Public? 

Will FDA Make Our R

Will FDA Make Our R

Public? Public?

 Before public disclosure of a r

will delete from the report: 

1. Any information that consti

secret or confidential commfinancial information under this chapter; and 

 Before public disclosure of a r

Before public disclosure of a r

will delete from the report: will delete from the report:

1.Any information that consti

Any information that consti

secret or confidential comm

secret or confidential comm

financial information under 

financial information under 

this chapter; and this chapter; and
Will FDA Make Our R

Public? 

Will FDA Make Our R

Will FDA Make Our R

Public? Public?

2. Any personnel, medical, or sim

information, including the seriaimplanted devices, which would clearly unwarranted invasion of privacy under 20.63 of this chaU.S.C. 552(b)(6); provided, thathe information under 20.61 of or 5 U.S.C. 552(b)(4), FDA will patient who requests a report ainformation in the report concepatient 

2.Any personnel, medical, or sim

Any personnel, medical, or sim

information, including the seria

information, including the seria

implanted devices, which would 

implanted devices, which would 

clearly unwarranted invasion of 

clearly unwarranted invasion of 

privacy under 20.63 of this cha

privacy under 20.63 of this cha

U.S.C. 552(b)(6); provided, tha

U.S.C. 552(b)(6); provided, tha

the information under 20.61 of 

the information under 20.61 of 

or 5 U.S.C. 552(b)(4), FDA will 

or 5 U.S.C. 552(b)(4), FDA will 

patient who requests a report a

patient who requests a report a

information in the report conce

information in the report conce

patient patient 
Will FDA Make Our R

Public? 

Will FDA Make Our R

Will FDA Make Our R

Public? Public?

 FDA has an obligation to prote

health by providing to consumeand timely information which mnegatively impact their health. 

 FDA has an obligation to protec

FDA has an obligation to prote

health by providing to consume

health by providing to consume

and timely information which m

and timely information which m

negatively impact their health. negatively impact their health.
In Summary In Summary

 In summary, the following topics w

presented: 

 Who must report corrections and  The requirements under Title 21 o

Federal Regulations, Part 806 

 Information regarding the content

Report 

 A web link to find the FDA District 

Coordinator to whom you should sreports 

 In summary, the following topics w

In summary, the following topics w

presented: presented:

 Who must report corrections and 

Who must report corrections and 

 The requirements under Title 21 o

The requirements under Title 21 o

Federal Regulations, Part 806 Federal Regulations, Part 806

 Information regarding the content

Information regarding the content

Report

 A web link to find the FDA District 

A web link to find the FDA District 

Coordinator to whom you should s

Coordinator to whom you should s

reports reports
Thank You Thank You

If you have further questions regarding 

requirements, you may contact: 

 FDA District Recall Coordinator 

www.fda.gov

/

Safety/Recalls/Industry

Guidance/ucm

or

CDRH-Division of Small Manufact

International and Consumer Assistance 

 1-800-638-2041  301-796-7100 dsmica@fda.hhs.gov

If you have further questions regarding 

If you have further questions regarding 

requirements, you may contact: requirements, you may contact:

 FDA District Recall Coordinator FDA District Recall Coordinator 

www.fda.gov www.fda.gov

/

Safety/Recalls/Industry ndustry

Guidance uidance/ucm

/ucm

or

CDRH

-Division of Small Manufact

Division of Small Manufact

International and Consumer Assistance 

International and Consumer Assistance 



1

-800

-638

-2041 

 301

-796

-7100

 dsmica@fda.hhs.gov dsmica@fda.hhs.gov