Recall Communicatio

Medical Device MPress Release 

Ronny BrownActing Chief, Recall BranchDivision of Risk Management OperationsU.S. Food and Drug AdministrationCenter for Devices and Radiological Health
What is a Recall Press R

 A Form of Public Warning 

 For urgent situations  Brief and to the point Issued promptly

www.fda.gov/Safety/Recall

www.fda.gov/Safety/Recall

IndustryGuidance/ucm129259

IndustryGuidance/ucm129259
When is a Press Release f

device recall recommende

 When products pose a significa

hazard (Class I Recalls and somRecalls)

 When other forms of notification 

consignees may be inadequate devices sold directly to consum
www.fda.gov/ICECI/ComplianceM

RegulatoryProceduresManual/ucm1

When is a Press Release fdevice recall recommende

 It is a policy that press releases a

all Class I medical device recalls unot be helpful to the public. For ex

 When initial consultation between pati

physicians is essential

 There is inadequate information to con

appropriate actions

 When product is limited to a small num

that are easily identified and reached contact

www.fda.gov/ICECI/ComplianceM

RegulatoryProceduresManual/ucm1
How can FDA support you 

preparing your Press Relea Consult your local District Reca

Coordinator before issuance wpossible.

 Use the Medical Device Press 

template in the Regulatory ProManual (RPM). 

 Consumers may benefit from th

joint press release by FDA and 

www.fda.gov/Safety/Recalls/I www.fda.gov/Safety/Recalls/IndustryGuidance

ndustryGuidance
For those recalls where FDA b

Press Release is warranted, thwill issue a Press Release if thfailed to do so, or if the firm-inpress release is not adequate

SEC. 705. [21 USC §375] Publicity(b) The Secretary may also cause to be diss

information regarding food, drugs, devices, or cosituations involving, in the opinion of the Secredanger health, or gross deception of the co

www.fda.gov/Safety/Recalls/IndustryGuidanc

www.fda.gov/Safety/Recalls/IndustryGuidanc

How can FDA support you preparing your Press Relea
How is the information in 

Release disseminated? The FDA Medical Device Recalls 

www.fda.gov/MedicalDevices/Sa

www.fda.gov/MedicalDevices/Sa

RecallsCorrectionsRemovals/ListofRecal

RecallsCorrectionsRemovals/ListofRecal

 General news media, either natio

as appropriate

 Specialized news media, e.g., pr

trade press.

www.fda.gov/MedicalDevices/De www.fda.gov/MedicalDevices/DeviceRegulatio

viceRegulatio

PostmarketRequirements/ PostmarketRequirements/

RecallsCorrectionsAndRemovals/defa
Medical 

Device Model Press Release:
Press Release: Header
Medical 

Device Model Press Release:
Press Release: Purpose of t

Release 
Medical 

Device Model Press Release:
Press Release: Identify 
Medical 

Device Model Press Release:
Press Release: What’s know

the recall
Medical 

Device Model Press Release:
www.fda.gov/ICECI/ComplianceM

RegulatoryProceduresManual/ucm17731

Press Release: Product Distribution 

www.fda.gov/ICECI/ComplianceM

RegulatoryProceduresManual/ucm17731
Medical 

Device Model Press Release:
Press Release: Contact 

Information 
Do not include in Press R

 Qualification data Promotional materials  Any other statement that may d

the message

www.accessdata.fda.gov/scripts/cdrh/c

www.accessdata.fda.gov/scripts/cdrh/c

CFRSearch.cfm?fr CFRSearch.cfm?fr=810.15 =810.15
Conclusion

 Press releases must provide cl

concise information concerning health risk to the users.

 Issue your press release prom Contact your District Office with 

press release to discuss conte
Helpful Links

 Medical Model Press Release;

www.fda.gov www.fda.gov/Safety/Recalls

/Safety/Recalls

IndustryGuidance/ucm129289

IndustryGuidance/ucm129289

 ORA District and Headquarters Recall 

www.fda.gov www.fda.gov/Safety/Recalls

/Safety/Recalls

IndustryGuidance/ucm129334

IndustryGuidance/ucm129334

 Recalls, Corrections and Removals (D

www.fda.gov/MedicalDevices www.fda.gov/MedicalDevices

DeviceRegulationandGuidance/Postmarket

DeviceRegulationandGuidance/Postmarket

RecallsCorrectionsAndRemovals/def

RecallsCorrectionsAndRemovals/de

 Title 21 of the Code of Federal Regulat

Enforcement Policy (21CFR 7) and Par806), www.accessdata.fda.gov/scripts

www.accessdata.fda.gov/scripts

cfCFR/CFRSearch.cfm cfCFR/CFRSearch.cfm
Helpful Links

 Regulatory Procedures Manual (RPM),

Chapter7 Recall Procedures;

www.fda.gov/ICECI/ComplianceMa

www.fda.gov/ICECI/ComplianceMa

RegulatoryProceduresManual/ucm17

RegulatoryProceduresManual/ucm17

 Guidance for Industry: Product Recall

Removals and Corrections;

www.fda.gov www.fda.gov/Safety/Recal

/Safety/Recal

IndustryGuidance/ucm129259

IndustryGuidance/ucm129259

 Compliance Activities;

www.fda.gov/MedicalDevice

www.fda.gov/MedicalDevice

DeviceRegulationandGuidance/Complia

DeviceRegulationandGuidance/Complia

default.htm default.htm
Thank You

If you have further questions r

reporting requirements, co

Your local FDA District Recall Coo

www.fda.gov www.fda.gov/Safety/Reca

/Safety/Reca

IndustryGuidance/ucm12933

IndustryGuidance/ucm1293

CDRH’s Division of Small Manuf

International and Consumer Assistan

at 1-800-638-2041, 301-796-7

dsmica@ fda.hhs.gov fda.hhs.gov
www.fda.gov/Safety/Reca

IndustryGuidance/ucm1293

dsmica@ fda.hhs.gov 

Thank You

If you have further questions r

reporting requirements, co

Your local FDA District Recall Coo

www.fda.gov/Safety/Reca

IndustryGuidance/ucm12933

CDRH’s Division of Small Manuf

International and Consumer Assistan

at 1-800-638-2041, 301-796-7

dsmica@ fda.hhs.gov