Control of Promotional/Advertising Materials

Mark Meer

Trusted Information Resource
#11
Has anybody here from Medical devices industry (not pharma) ever got cited by FDA ( on a 483 letter) for their misleading information on their marketing and promotional material? I want to know what level of RA/QA review and approval is required on these documents, some of our promotional and marketing material don't even have health-related claims on them , so I really don't think RA/QA review and approval is needed on such documents?
Short answer: No, never got cited, and in my experience auditors aren't all that interested in examining control of promotional materials.

HOWEVER:

1. Technically you would be non-compliant. The FDA's Introduction to Medical Device Labeling clearly states "labelling" is anything accompanying product, and "The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc.", and 21 CFR §820.120 clearly lists control requirements for "labelling".

2. From a QA/RA perspective, it's probably still prudent to exercise some controls, no? You presumably don't want people creating new marketing material, or changing existing ones willy-nilly...

Side Note: In the Introduction to Medical Device Labeling under the "Advertising" heading, it says "According to an appellate court decision: 'Most, if not all advertising, is labeling.'". Any guidance as to what is excluded? Probably safer to just assume "all"...but I'd be interested to know where the exceptions lie.

Edit: For some reason I thought you we talking quality controls in general. I realise now that you are just referring to "RA/QA review and approval". In this case, the only thing required by 21 CFR §820.120 is that labeling is released by "designated individual(s)"...so you could potentially qualify anyone as you deem appropriate.
 
Last edited:
Elsmar Forum Sponsor
#12
Short answer: No, never got cited, and in my experience auditors aren't all that interested in examining control of promotional materials.

HOWEVER:

1. Technically you would be non-compliant. The FDA's Introduction to Medical Device Labeling clearly states "labelling" is anything accompanying product, and "The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc.", and 21 CFR §820.120 clearly lists control requirements for "labelling".

2. From a QA/RA perspective, it's probably still prudent to exercise some controls, no? You presumably don't want people creating new marketing material, or changing existing ones willy-nilly...

Side Note: In the Introduction to Medical Device Labeling under the "Advertising" heading, it says "According to an appellate court decision: 'Most, if not all advertising, is labeling.'". Any guidance as to what is excluded? Probably safer to just assume "all"...but I'd be interested to know where the exceptions lie.

Edit: For some reason I thought you we talking quality controls in general. I realise now that you are just referring to "RA/QA review and approval". In this case, the only thing required by 21 CFR §820.120 is that labeling is released by "designated individual(s)"...so you could potentially qualify anyone as you deem appropriate.


Mark,

Thank you for your input. Yes, i meant both quality/regulatory control on such marketing materials. for example our company ( Med device) publishes numerous amount of marketing and promotional materials pertaining to our different med devices. all those documents are routed for RA/QA approval (takes up a lot of our time to review and approve them on a daily basis). However, I think for some of them such as the Fee Schedules ( includes name of the device and their prices along with their compatibility status with other systems) RA/QA review is really not needed. I just can't seem to find where to draw that line as to what marketing materials require RA/QA input and what does not ( they can be published without any RA/QA involvement).
As you mentioned all advertising materials are pretty much considered labeling and therefore subject to RA/QA review. But I was trying to find a justification as to what claims can be made with no RA involvement ( for example if it's not a 'health related' claim, it does not require RA approval).
 
Thread starter Similar threads Forum Replies Date
J Control of Medical Device Marketing and Promotional Materials - EU regulation EU Medical Device Regulations 20
A Control and Management of Promotional Materials for Medical Device and Pharmaceutical Document Control Systems, Procedures, Forms and Templates 14
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C UDI Questions on Control Units Other US Medical Device Regulations 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
M Control-self assessment Internal Auditing 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
A Prototype control plan FMEA and Control Plans 2
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Monitoring and Control Instruments RoHS, REACH, ELV, IMDS and Restricted Substances 3
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 11
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
T Linking Control Plans and PFMEA's FMEA and Control Plans 3
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 12
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
D All Dimensions listed on control plan FMEA and Control Plans 10
W Need for current design or process control FMEA and Control Plans 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8

Similar threads

Top Bottom