Introduction Introduction 

Medical Medical Devi

Recalls Recalls

Industry Industry Responsibilit

Responsibilit
Table of Content

Table of Content

 Purpose Purpose

• 

• Explain to Industry what their role 

Explain to Industry what their role 

responsibilities are in a Medical De

responsibilities are in a Medical D

 Introduction to Medical Device 

Introduction to Medical Device 

 Basics of a Recall Basics of a Recall Medical Device Recall Determination & 

Medical Device Recall Determination & 

 Medical Device Recall Reporting Medical Device Recall Reporting Recall Responsibilities & Requirement

Recall Responsibilities & Requirement

 FDA’s Role
What is a Recall

 A firm’s voluntary voluntary removal removal or correc

correc

marketed marketed product product that the FDA cons

cons

violation violation of the FD&C Act and agains

agains

would initiate initiate legal action

• E.g., Seizure Seizure

 A voluntary voluntary action taken by a firm w

determine determine a device is misbranded misbranded or 

•Misbranded Misbranded –includes but is not l

includes but is not l

false or misleading representation false or misleading representation 
What is a Recal

What is a Reca

 Adulterated Adulterated

– includes but is not li

includes but is not li

device that does not meet the perfo

device that does not meet the perfo

standard established under section 5

standard established under section 5

FD&C Act; a device that is not in con

FD&C Act; a device that is not in con

with any standard that is recognized 

with any standard that is recognized 

section 514 (c); a Class III device th

section 514 (c); a Class III device th

have premarket approval; a banned 

have premarket approval; a banned 

device that is not in conformance wi

device that is not in conformance wi

requirements under section 520(f)(1

requirements under section 520(f)(1

520(f)(2); and if it is a device for wh

520(f)(2); and if it is a device for wh

exemption has been granted under s

exemption has been granted under 

520(g) for investigational use and th

520(g) for investigational use and th

granted the exemption fails to comp

granted the exemption fails to comp

requirements prescribed. requirements prescribed.
What is a Recall

 An effective effective method to remove or co

co

regulated regulated products productsfrom the market 

 An alternative alternative to FDA initiated initiated court 

removing removing violative violative products productsfrom th

(seizure) (seizure) or import detention detention

• Violative Violative Product Product – a product product that is in v

v

applicable applicable regulatory regulatory and statutory statutory laws 

a recall. recall. Typically, Typically, medical medical device recalls recalls 

the device is either Adulterated, Adulterated, §501 or 

§502 of the Act.
Who can initiat

initia

Medical Medical Devi

Recall? Recall?
Firm Initiated Initiated

 On its own volition volition decides decidesto 

• Recalling Recalling Firm – firm that initiat

initiat

the firm that has primary primary respo

respo

the manufacture manufacture and marketing marketing 

product product to be recalled. recalled.
Not Sure If Y

Not Sure If Y

Have a Medi

Have a Medi

Device Recal

Device Reca
How to determine determine if you 

Medical Medical Device Reca

 Does it meet the following following criteria: criteria:

• A Removal Removal ‐ the physical physical confiscation confiscation (by recallin

recalli

government) government) from where it is used or sold, to s

for:

3⁄4 Repair3⁄4 Modification Modification3⁄4 Adjustment Adjustment3⁄4 Relabeling Relabeling3⁄4 Destruction Destruction3⁄4 Inspection Inspection

• A Removal Removal is not part of regularly regularly scheduled scheduled ma

ma
How to determine determine if you 

Medical Medical Device Reca

 Does it meet the following following criteria: criteria:

• A Correction Correction – On site

3⁄4 Repair3⁄4 Modification Modification3⁄4 Adjustment Adjustment3⁄4 Relabeling Relabeling3⁄4 Destruction Destruction3⁄4 Inspection Inspection3⁄4 Including Including patient patient monitoring monitoring
How to determine determine if you 

Medical Medical Device Recall o



A Correction Correction or Removal Removal Action is NO

it

’

s a:

o Market Withdrawal Withdrawal

– firm’s removal removal or c

c

distributed distributed product product which involves involves no vi

vi

minor violation violation that would not be subjec

subjec

by the FDA.

o E.g., normal stock rotation rotation practices, practices, routine routine e

e

adjustments adjustments and repairs, repairs, etc.

o Stock Recovery Recovery

– firm’s removal removal or corre

corre

product product that has not been marketed marketed or t

the direct control control of the firm.

o Safety Alert

– notification notification by responsible responsible 

device users that the use of

a device ma

circumstances, circumstances, pose

a risk of substantial substantial 
Where and W

Should Be Repo

Repo
Reports Reports of Correction Correction and 

 The Center for Devices Devices and Radiol

Radiol

Health requires requiresfirms to follow 21 

806 for Reporting Reporting Medical Medical Devices Devices 

 It requires requires a firm to report when t

to health

 This information information should be report

report

firm’s FDA District District Office
Recalling Recalling Firm’s Respons

Respons

• Submit a written written report of any co

co

or removal removal of a device within 10 w

w

days, including including the following following info

info

 Correction Correction or removal removal report num Manufacturers Manufacturers name and contac

contac

information, information, including including contact contact pe

 Importers Importers name and contact contact info

info

 Device brand name, common na

intended intended use
Recalling Recalling Firm’s Respons

Respons

 Marketing Marketing status, status, device model, catalo

catalo

number, number, lot number, number,serial number, number, et

 Description Description of event giving rise to reca Corrective Corrective or removal removal actions actionsthat hav

and are expected expected to be taken

 Any related related illness illness or injuries injuriesthat have

occurred occurred with the use of the device
Recalling Recalling Firm’s Respons

Respons

 Total number and dates of devices devices

manufactured manufactured and distributed distributed that 

to the recall, recall, including including expiration expiration dexpected expected life

 Names and contact contact information information of 

and foreign foreign consignees consignees and numbedistributed distributed to each

 Copy of all communications communicationsregard

regard

correction correction or removal, removal, including including na

contact contact information information of all recipien

recipien

communications, communications, including including recall le
Recalling Recalling Firm’s Respons

Respons

In the event that the req

req

information information is not imme

imme

available, available, a statement statement m

submitted submitted stating stating why it available available and when it wi
FDA’s Enforcement Enforcement P

 Under 21 CFR Part 7, FDA rec

Under 21 CFR Part 7, FDA rec

that a recalling firm report th

that a recalling firm report th

information information:

•Product identity Product identity•Reason, date discovered Reason, date discovered•Risk Evaluation Risk Evaluation•Quantity manufactured and distr

Quantity manufactured and distr

•Distribution information for all co

Distribution information for all co

•Recall letter or script Recall letter or script•Recall Strategy Recall Strategy•Recalling firm official Recalling firm official’s contact in

s contact in
Adverse Consequen

Adverse Consequen

Risk to Health Risk to Health

Health Hazard Evalua

Health Hazard Evalua
A Firm’s Strategy Strategy

 A planned planned specific specific course of action to be take

a recall, recall, which addresses addressesthe depth of recall, recall, 

warnings, warnings, and extent of effectiveness effectiveness checks 

 An effective effective recall strategy strategy takes into account

account

• The results results of the risk assessment assessment

• Ease of identifying identifying the affected affected product(s product(s)

• Degree to which the product product’s deficiency deficiency i

consumer consumer or user

• Degree to which the product product remains remains unu

market‐place

• Continued Continued availability availability of essential essential product

product
A Firm’s Recall Commun

Commun

 A recalling recalling firm has a responsibility responsibility t

consignees, consignees, anyone who received, received, p

p

used the product product being recalled, recalled, to:

• Promptly Promptly notify its direct accounts accounts via a 

communication communication

 e.g. By issuing issuing press releases releases or providi

providi

instructions instructions
A Firm’s Recall Commun

Commun

• Should supply information information to help u

identify identify the product product and take steps 

minimize minimize health consequences consequences

 Identify Identify product productsubject subject to recall Explain Explain reason for the recall and hazard  Further Further distribution distribution or use should cease  Direct accounts accountsshould notify its custom

custom

received received the product, product, where appropriat

appropriat

 Instructions Instructionsshould be included included regardin

regardin

with the product product
•The recall communication shou

The recall communication shou

contain irrelevant qualification

contain irrelevant qualification

promotional materials, or any 

promotional materials, or any 

statement that may detract fro

statement that may detract fro

message. message.

•Consignees that receive a reca

Consignees that receive a reca

communication should immedi

communication should immedi

carry out the instructions set f

carry out the instructions set f

the recalling firm and, where n

the recalling firm and, where n

extend the recall to its consign

extend the recall to its consign

A Firm’s Recall Commun

Commun
•To take action to prevent the 

To take action to prevent the 

from happening again from happening again

•Telephone calls or other pers

Telephone calls or other pers

contacts should be confirmed 

contacts should be confirmed 

written communication and o

written communication and o

documented in an appropria

documented in an appropria

manner. manner.

A Firm’s Recall Commun

Commun
A Firm’s Recall Strat

Strat

 The recall strategy strategy also includes includesthe 

elements elements:

• Depth – level in the distribution distribution chain

• Public Warning Warning – purpose purpose is to alert the 

product product being recalled recalled presents presents a seriou

seriou

health

• Effectiveness Effectiveness Checks – verifies verifiesthat all co

co

recall depth specified specified have received received noti

noti

have taken appropriate appropriate action

 The recall strategy strategy will specify specify the m

m

be used for and the level of effective

effective

that will be conducted conducted
Firm’s Follow s Follow

Responsibilit

Responsibilit
Quality Quality System Require

Require

 Firms are responsible for following the 

System Requirements found in 21 CFR 

thru 21 CFR 820.250

• Establishing and maintaining proced

implementing corrective and preve

 This will aid in ensuring that the neces

fixes are made on all units

 Additional information can be viewed 

www.fda.gov/Training/CDRHLe2015.htm

 Firms are responsible responsible for following following the 

System Requirements Requirementsfound in 21 CFR 

thru 21 CFR 820.250 820.250

• Establishing Establishing and maintaining maintaining proced

proced

implementing implementing corrective corrective and preven

preve

 This will aid in ensuring ensuring that the neces

neces

fixes are made on all units

 Additional Additional information information can be viewed 

www.fda.gov/Training/CDRHLe

www.fda.gov/Training/CDRHLe

2015.htm 2015.htm
Things to Consider Consider When R

R

Your Medical Medical Devic

 Do you recognize recognize when you have a cris

cris

situation situation on your hands?

 Does your firm intend to voluntarily voluntarily re

re

crisis or recall situation situation without without FDA in

in

 Does your firm have in place a process process

and control control the risk?

 Do you have sufficient sufficient policies, policies, proced

proced

personnel personnel and skills to bring the risk do

acceptable acceptable levels? levels?

 Can you properly properly identify identify the affected affected 

problem problem and the cause(s cause(s) of the proble

proble
Things to Consider Consider When R

R

Your Medical Medical Devic

 Device Shortage Shortage and Recalls Recalls

• Shortages Shortages may require require Recall Strateg

Strateg

modification modification based on the risk asses

asses

benefit benefit vs. risk of removal removal

• Verification Verification

 1‐Change Recall Depth or Delay 2‐Detailed Detailed Instructions Instructions and monitoring monitoring

• Constant Constant Agency re‐evaluation evaluation

• Agency Determination Determination
Recall Status Repo

Recall Status Repo

 FDA requests that a recalling fi

FDA requests that a recalling fi

recall status reports to their FD

recall status reports to their FD

Office. Office.

•This is so the agency This is so the agency may assess 

may assess 

of the recall of the recall

 The frequency of these reports 

The frequency of these reports 

determined by the relative urge

determined by the relative urge

recall and will be specified by th

recall and will be specified by t

•Generally between 2 and 4 weeks

Generally between 2 and 4 weeks
Recall Status Repo

Recall Status Repo

 Should contain the following inf

Should contain the following inf

• 

• The number of consignees th

The number of consignees th

notified of the recall, along w

notified of the recall, along w

date and method of notificati

date and method of notificati

•The number of consignees th

The number of consignees th

responded to the recall comm

responded to the recall comm

and quantity of products on h

and quantity of products on h

time it was received. time it was received.

• 

• The number of consignees th

The number of consignees th

unresponsive. unresponsive.
Recall Status Repo

Recall Status Repo

• 

• The number of products returned 

The number of products returned 

by each consignee contacted and 

by each consignee contacted and 

of products accounted for. of products accounted for.

•The number and results of effectiv

The number and results of effectiv

checks that were conducted. checks that were conducted.

•The estimated time frames for com

The estimated time frames for co

the recall. the recall.

 Recall status reports are to be Recall status reports are to be 

discontinued when the recall is 

discontinued when the recall is 

by the FDA. by the FDA.
Firm’s Recall Responsib

s Recall Responsib

Summary Summary

 Determine Determine the need for a recall Conduct Conduct a risk assessment assessment Conduct Conduct a root cause analysis, analysis, i.e. 

of the problem problem

 Notify the FDA District District Office Execute Execute appropriate appropriate recall actions actions Improve Improve product product quality quality for the fu
FDA Expectation

FDA Expectation

 Once a decision to recall ha

Once a decision to recall ha

made, contact your District 

made, contact your District 

Coordinator Coordinator

 Conduct Effectiveness chec

Conduct Effectiveness chec

5

-7 days of Recall Letter iss

7 days of Recall Letter iss

 A timeline of implementatio

A timeline of implementatio

product returns and correct

product returns and correct

 Submit Termination Submit Termination 

Recommendation in a timel

Recommendation in a timel
FDA’s Role

A Brief Overview A Brief Overview 
Recall Classifica

Classifica

Classification Classification – is the recall classif

classi

assigned assigned by FDA, i.e. Class I, Clas

Class III Recall Classes, Classes, to indica

indica

relative relative degree of risk to public h

the product product being recalled recalled or con

con

for recall. recall.
Recall Classificatio

Classificatio

Class I Recall

‐

A Situation Situation in which there is

a 

probability probability that the use of, or exposure exposure to,

product product will cause serious serious adverse adverse health 

or death

• The recalling recalling firm notifies notifiesits customer

customer

them to notify the intended intended recipients recipients 

• The notification notification usually usually contains containsthe na

device being recalled, recalled, identifying identifying lot or 

numbers; numbers; the reason for the recall; recall; exp

exp

the risk involved; involved; and instructions instructions abou

correct, correct, avoid, or minimize minimize the problem

problem

provide provide

a telephone telephone number for quest

quest

the recall. recall.

• The recalling recalling firm issues

a press release release 

public, public, if appropriate appropriate to minimize minimize healt

consequences. consequences.
Class I Recall Exam

Class I Recall Exam

 A situation in which a cathe

A situation in which a cathe

kink or rupture during use l

kink or rupture during use l

remnants behind in the pat

remnants behind in the pat

will cause serious patient in

will cause serious patient in

death.
Recall Classificatio

Classificatio

 Class II Recall ‐ A situation situation in which use 

to, a violative violative product product may cause tempora

tempora

reversible reversible adverse adverse health consequences consequences or 

probability probability of serious serious adverse adverse health cons

cons

remote

• The recalling recalling firm notifies notifiesits customers customers 

asks them to notify the intended intended recipie

recipie

device. device.

• A press release release would be issued if there 

need to do so

 E.g. if the device could affect the health of a la

people, people, if patients patients need more information, information, or 

could not reach every intended intended recipient recipient
Class II Recall Exam

Class II Recall Exam

 A package defect in which s

A package defect in which s

has been compromised and 

has been compromised and 

lead to contamination of th

lead to contamination of th

device and result in patient device and result in patient complications. complications.
Recall Classificatio

Classificatio

 Class III Recall ‐ A situation situation in 

of, or exposure exposure to, a violative violative pr

pr

not likely to cause adverse adverse heal

consequences consequences.

• The recalling recalling firm notifies notifiesits custo

custo

• Press release release is not usually usually expect

expect
Class III Recall Exa

Class III Recall Exa

 A labeling defect where the A labeling defect where the 

expiration date does not ap

expiration date does not ap

the product label. the product label.

 A mislabeled package that c

A mislabeled package that 

one size of a particular med

one size of a particular med

device but is labeled as ano

device but is labeled as ano
FDA Can Als

FDA Can Al

Initiate a Med

Initiate a Med

Device Reca

Device Reca
FDA Recalling Recalling Medical Medical D

D

 FDA Requested Requested

1. Based on risk of illness illness or injury or 

consumer consumer deception deception

2. Firm is aware of the risk but is not a

own initiative initiative

3. When necessary necessary to protect protect the pub

and welfare welfare

 FDA Ordered Ordered

• 21 CFR Part 810.13 and 518e of The 

Drug & Cosmetic Cosmetic Act (FD&C Act)
What can FDA do when a 

reluctant reluctant to conduct conduct a r

r

 Conduct Conduct a Health Risk Assessment Assessment – It is 

responsibility responsibility to evaluate evaluate the risk prior t

with the firm

 Discuss Discuss our evaluation evaluation of risk – face to fa

phone

 Issue Public Notification Notification FDA Ordered/Mandatory Ordered/Mandatory Recall (Class I H

Hazard/Requirements Hazard/Requirements(518 (e) 21 CFR 81

 Seize product product Injunction Injunction – Recall clause in consent consent agr

agr

 Place firm on Import alert Foreign Foreign Country Country Notification Notification
In Review In Review

 The firm responsible for the The firm responsible for the vio

vio

medical device should initiate a 

medical device should initiate a 

 Firm should report the recall to 

Firm should report the recall to 

District Office. District Office. 

 Firm should follow protocol to p

Firm should follow protocol to p

communicate the recall with co

communicate the recall with co

 Firm should submit up to date s

Firm should submit up to date 

reports. reports.

 If necessary the FDA can initiat

If necessary the FDA can initiat

requested or ordered recall. requested or ordered recall. 
Regulations/Referen

Regulations/Referen

 Food, Drug and Cosmetic Act (FD&C 

Food, Drug and Cosmetic Act (FD&C 

 21 CFR Part 7 (Enforcement Policy) 21 CFR Part 7 (Enforcement Policy) 21 CFR Part 806 (Mandatory Reports 

21 CFR Part 806 (Mandatory Reports 

and Removals), 810 and 820 and Removals), 810 and 820

 Federal Register (June 16, 1978), Pa

Federal Register (June 16, 1978), Pa

 Regulatory Procedures Manual (RPM) 

Regulatory Procedures Manual (RPM) 
References References

 Medical Technology Learning In

Medical Technology Learning In

Recalls from A Recalls from A

-Z: Regulations, 

Z: Regulations, 

Procedures, Best Practices (Nov

Procedures, Best Practices (No

2008)

 Checklist for Reports of Correct

Checklist for Reports of Correc

Removal 806.10(a)(1 Removal 806.10(a)(1

-13)

 FDA 101: Product Recalls, From 

FDA 101: Product Recalls, From 

to Effectiveness Checks to Effectiveness Checks

•( http:// http://www.fda.gov www.fda.gov/consumer /consumer

)
Medical Device Recal

Medical Device Recal

www.fda.gov/MedicalDevices

www.fda.gov/MedicalDevice

RecallsCorrectionsRemoval

RecallsCorrectionsRemoval

htm

Guidance Documents, 

Guidance Documents, 

websites websites

(www.accessdata.fda.gov/script

www.accessdata.fda.gov/script

ocs/cfRES/res.cfm ocs/cfRES/res.cfm

)

and Databases and Databases

References References