SlideShare a Scribd company logo
How the FDA Regulates the Advertising of
Medical Devices
By: Nikita Angane
FDA regulates the labeling and advertising of all pharmaceutical products; however, it regulates
the labeling of all medical devices and the advertising of only restricted devices.
Currently, only two types of class I & class II devices fall under the restricted devices category.
One is hearing aids and the other is Analyte Specific Reagents (ASRs). FDA may designate the
restricted device category for devices that are approved via the PMA route. Thus, most of the
class III devices are restricted, while no class I or class II devices are restricted except for the
hearing aids and ASRs.i
FDA, however, does have the authority to regulate the advertising of the non-restricted devices
related to its intended use. FDA issued several draft guidance documents in the past but has not
made any of them a final rule until now. The said draft guidance documents are:
1. Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and
Benefit Information for Prescription Drugs and Medical Devicesii
2. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation
About Prescription Drugs and Medical Devices iii
3. Presenting Risk Information in Prescription Drug and Medical Device Promotioniv
The first guidance is about how to communicate the risk information about the device/drug on
media sites that have character space limitations such as twitter, which has a limit of about 280
characters.
The second guidance document applies to information published by third parties on the social
media/internet regardless of that information being presented on the company’s own internet
platforms or third-party platforms.
The third guidance document describes how the FDA evaluates the promotional pieces of
prescription drugs and medical devices for the disclosure of the risk information to ensure that
the benefits and the risks are accurate and not misleading.
The recommendations in these guidance documents apply to the promotional materials directed
to the consumers, as well as healthcare professionals. However, these draft guidance documents
have not become a final rule.
Page 2 of 2
i Hyman, Phelps & McNamara (2014) What Legal Authority Does FDA Have to Regulate Medical Device Promotion
on Internet Social Media Platforms? Retrieved on 07/24/2019 from http://www.fdalawblog.net/2014/09/what-
legal-authority-does-fda-have-to-regulate-medical-device-promotion-on-internet-social-media-pla/
ii FDA (June 2014) Guidancefor Industry Internet/Social Media Platforms with Character SpaceLimitations —
Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices retrieved on 07/24/2019
fromhttps://www.fda.gov/media/88551/download
iii FDA (June 2014) Guidancefor Industry Internet/Social Media Platforms:Correcting Independent Third-Party
Misinformation AboutPrescription Drugs and Medical Devices retrieved on 07/24/2019 from
https://www.fda.gov/media/88545/download
iv FDA (May 2009) Guidancefor Industry Presenting Risk Information in Prescription Drugand Medical Device
Promotion retrieved on 07/24/2019 from https://www.fda.gov/media/76269/download

More Related Content

What's hot

Five Minute Market Snapshot April 2011
Five Minute Market Snapshot April 2011Five Minute Market Snapshot April 2011
Five Minute Market Snapshot April 2011
nancydivito
 
Use of testimonials and endorsements in prescription drug advertisements
Use of testimonials and endorsements in prescription drug advertisementsUse of testimonials and endorsements in prescription drug advertisements
Use of testimonials and endorsements in prescription drug advertisements
Freedom Monk
 
News You Can Use 5.4.16
News You Can Use 5.4.16News You Can Use 5.4.16
News You Can Use 5.4.16
Allison Oesterle, MSc
 
Remote patient monitoring devices market is estimated to increase to us$ 1,50...
Remote patient monitoring devices market is estimated to increase to us$ 1,50...Remote patient monitoring devices market is estimated to increase to us$ 1,50...
Remote patient monitoring devices market is estimated to increase to us$ 1,50...
Rakesh Zanje
 
ThinkDigital 2010 Research
ThinkDigital 2010 ResearchThinkDigital 2010 Research
ThinkDigital 2010 Research
Digitas Health LifeBrands
 
Patient Monitoring Global Market – Forecast to 2020
Patient Monitoring Global Market – Forecast to 2020Patient Monitoring Global Market – Forecast to 2020
Patient Monitoring Global Market – Forecast to 2020
Market Research Reports, Inc.
 
Az social media_white_paper
Az social media_white_paperAz social media_white_paper
Az social media_white_paper
Óscar Miranda
 
Online communication channels between physicians and pharma
Online communication channels between physicians and pharmaOnline communication channels between physicians and pharma
Online communication channels between physicians and pharma
Eye For Pharma Events
 
Introduction to Vichara Health
Introduction to Vichara HealthIntroduction to Vichara Health
Introduction to Vichara Health
Pranish Kantesaria, PharmD
 

What's hot (9)

Five Minute Market Snapshot April 2011
Five Minute Market Snapshot April 2011Five Minute Market Snapshot April 2011
Five Minute Market Snapshot April 2011
 
Use of testimonials and endorsements in prescription drug advertisements
Use of testimonials and endorsements in prescription drug advertisementsUse of testimonials and endorsements in prescription drug advertisements
Use of testimonials and endorsements in prescription drug advertisements
 
News You Can Use 5.4.16
News You Can Use 5.4.16News You Can Use 5.4.16
News You Can Use 5.4.16
 
Remote patient monitoring devices market is estimated to increase to us$ 1,50...
Remote patient monitoring devices market is estimated to increase to us$ 1,50...Remote patient monitoring devices market is estimated to increase to us$ 1,50...
Remote patient monitoring devices market is estimated to increase to us$ 1,50...
 
ThinkDigital 2010 Research
ThinkDigital 2010 ResearchThinkDigital 2010 Research
ThinkDigital 2010 Research
 
Patient Monitoring Global Market – Forecast to 2020
Patient Monitoring Global Market – Forecast to 2020Patient Monitoring Global Market – Forecast to 2020
Patient Monitoring Global Market – Forecast to 2020
 
Az social media_white_paper
Az social media_white_paperAz social media_white_paper
Az social media_white_paper
 
Online communication channels between physicians and pharma
Online communication channels between physicians and pharmaOnline communication channels between physicians and pharma
Online communication channels between physicians and pharma
 
Introduction to Vichara Health
Introduction to Vichara HealthIntroduction to Vichara Health
Introduction to Vichara Health
 

Similar to How the FDA Regulates the Advertising of Medical Devices

FDA Regulation of Mobile Medical Applications
FDA Regulation of Mobile Medical ApplicationsFDA Regulation of Mobile Medical Applications
FDA Regulation of Mobile Medical Applications
Michael Swit
 
FDA Approved vs FDA Cleared
FDA Approved vs FDA ClearedFDA Approved vs FDA Cleared
FDA Approved vs FDA Cleared
EMMAIntl
 
Classifying Medical Devices
Classifying Medical DevicesClassifying Medical Devices
Classifying Medical Devices
EMMAIntl
 
Fda mobile medical apps 2013
Fda mobile medical apps 2013Fda mobile medical apps 2013
Fda mobile medical apps 2013
Alfonso Gadea
 
mobile medical applications
mobile medical applicationsmobile medical applications
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
CRF Health
 
FDA the Gold Standard for Medical Device Safety
FDA the Gold Standard for Medical Device SafetyFDA the Gold Standard for Medical Device Safety
FDA the Gold Standard for Medical Device Safety
EMMAIntl
 
Fda communications-oversight-in-a-digital-era
Fda communications-oversight-in-a-digital-eraFda communications-oversight-in-a-digital-era
Fda communications-oversight-in-a-digital-era
Freedom Monk
 
Device registration and listing of medical devices on the US market
Device registration and listing of medical devices on the US marketDevice registration and listing of medical devices on the US market
Device registration and listing of medical devices on the US market
ttopstart B.V.
 
regulatory aspects of medical devices in USA
regulatory aspects of medical devices in USAregulatory aspects of medical devices in USA
regulatory aspects of medical devices in USA
navyasribandaru
 
Pharma, Social Media, & Mobile A Happy Ménage à Trois?
Pharma, Social Media, & Mobile A Happy Ménage à Trois?Pharma, Social Media, & Mobile A Happy Ménage à Trois?
Pharma, Social Media, & Mobile A Happy Ménage à Trois?
Pharma Guy
 
Navigating FDA’s Social Media Guidelines for Medical Devices.pdf
Navigating FDA’s Social Media Guidelines for Medical Devices.pdfNavigating FDA’s Social Media Guidelines for Medical Devices.pdf
Navigating FDA’s Social Media Guidelines for Medical Devices.pdf
dnyaneshwarivedpatha1
 
Social media in_pv_whitepaper
Social media in_pv_whitepaperSocial media in_pv_whitepaper
Social media in_pv_whitepaper
Saurabh Singh
 
Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...
Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...
Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...
Covance
 
Medical Device Ban in USFDA
Medical Device Ban in USFDA Medical Device Ban in USFDA
Medical Device Ban in USFDA
Tamil423646
 
Determining if Your Product is a Medical Device
Determining if Your Product is a Medical DeviceDetermining if Your Product is a Medical Device
Determining if Your Product is a Medical Device
EMMAIntl
 
2011 raps presentation subcontractors software social media fox rev 2
2011 raps presentation subcontractors software social media fox rev 22011 raps presentation subcontractors software social media fox rev 2
2011 raps presentation subcontractors software social media fox rev 2
Erik Vollebregt
 
FDA Drug Approval Regulations & Safety
FDA Drug Approval Regulations & SafetyFDA Drug Approval Regulations & Safety
FDA Drug Approval Regulations & Safety
Dr Dev Kambhampati
 
Pro medoss
Pro medoss Pro medoss
Pro medoss
Guy Vinograd ☁
 
Request for Comments on Risk-Based Regulatory Framework for Health IT
Request for Comments on Risk-Based Regulatory Framework for Health ITRequest for Comments on Risk-Based Regulatory Framework for Health IT
Request for Comments on Risk-Based Regulatory Framework for Health IT
Patton Boggs LLP
 

Similar to How the FDA Regulates the Advertising of Medical Devices (20)

FDA Regulation of Mobile Medical Applications
FDA Regulation of Mobile Medical ApplicationsFDA Regulation of Mobile Medical Applications
FDA Regulation of Mobile Medical Applications
 
FDA Approved vs FDA Cleared
FDA Approved vs FDA ClearedFDA Approved vs FDA Cleared
FDA Approved vs FDA Cleared
 
Classifying Medical Devices
Classifying Medical DevicesClassifying Medical Devices
Classifying Medical Devices
 
Fda mobile medical apps 2013
Fda mobile medical apps 2013Fda mobile medical apps 2013
Fda mobile medical apps 2013
 
mobile medical applications
mobile medical applicationsmobile medical applications
mobile medical applications
 
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...
 
FDA the Gold Standard for Medical Device Safety
FDA the Gold Standard for Medical Device SafetyFDA the Gold Standard for Medical Device Safety
FDA the Gold Standard for Medical Device Safety
 
Fda communications-oversight-in-a-digital-era
Fda communications-oversight-in-a-digital-eraFda communications-oversight-in-a-digital-era
Fda communications-oversight-in-a-digital-era
 
Device registration and listing of medical devices on the US market
Device registration and listing of medical devices on the US marketDevice registration and listing of medical devices on the US market
Device registration and listing of medical devices on the US market
 
regulatory aspects of medical devices in USA
regulatory aspects of medical devices in USAregulatory aspects of medical devices in USA
regulatory aspects of medical devices in USA
 
Pharma, Social Media, & Mobile A Happy Ménage à Trois?
Pharma, Social Media, & Mobile A Happy Ménage à Trois?Pharma, Social Media, & Mobile A Happy Ménage à Trois?
Pharma, Social Media, & Mobile A Happy Ménage à Trois?
 
Navigating FDA’s Social Media Guidelines for Medical Devices.pdf
Navigating FDA’s Social Media Guidelines for Medical Devices.pdfNavigating FDA’s Social Media Guidelines for Medical Devices.pdf
Navigating FDA’s Social Media Guidelines for Medical Devices.pdf
 
Social media in_pv_whitepaper
Social media in_pv_whitepaperSocial media in_pv_whitepaper
Social media in_pv_whitepaper
 
Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...
Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...
Unleashing the Potential of Social Media in Drug Safety Exploring the Increas...
 
Medical Device Ban in USFDA
Medical Device Ban in USFDA Medical Device Ban in USFDA
Medical Device Ban in USFDA
 
Determining if Your Product is a Medical Device
Determining if Your Product is a Medical DeviceDetermining if Your Product is a Medical Device
Determining if Your Product is a Medical Device
 
2011 raps presentation subcontractors software social media fox rev 2
2011 raps presentation subcontractors software social media fox rev 22011 raps presentation subcontractors software social media fox rev 2
2011 raps presentation subcontractors software social media fox rev 2
 
FDA Drug Approval Regulations & Safety
FDA Drug Approval Regulations & SafetyFDA Drug Approval Regulations & Safety
FDA Drug Approval Regulations & Safety
 
Pro medoss
Pro medoss Pro medoss
Pro medoss
 
Request for Comments on Risk-Based Regulatory Framework for Health IT
Request for Comments on Risk-Based Regulatory Framework for Health ITRequest for Comments on Risk-Based Regulatory Framework for Health IT
Request for Comments on Risk-Based Regulatory Framework for Health IT
 

More from EMMAIntl

Cartilage Regeneration Techniques
Cartilage Regeneration TechniquesCartilage Regeneration Techniques
Cartilage Regeneration Techniques
EMMAIntl
 
Stability Testing of Pharmaceuticals and Supplements
Stability Testing of Pharmaceuticals and SupplementsStability Testing of Pharmaceuticals and Supplements
Stability Testing of Pharmaceuticals and Supplements
EMMAIntl
 
Intolerance vs. Allergy
Intolerance vs. AllergyIntolerance vs. Allergy
Intolerance vs. Allergy
EMMAIntl
 
Material Science in MedTech
Material Science in MedTechMaterial Science in MedTech
Material Science in MedTech
EMMAIntl
 
Investigating Ketamine for Parkinson’s Disease
Investigating Ketamine for Parkinson’s DiseaseInvestigating Ketamine for Parkinson’s Disease
Investigating Ketamine for Parkinson’s Disease
EMMAIntl
 
Aduhelm, an Accelerated Approval for Alzheimer’s
Aduhelm, an Accelerated Approval for Alzheimer’sAduhelm, an Accelerated Approval for Alzheimer’s
Aduhelm, an Accelerated Approval for Alzheimer’s
EMMAIntl
 
World Blood Donor Day 2021
World Blood Donor Day 2021World Blood Donor Day 2021
World Blood Donor Day 2021
EMMAIntl
 
New COVID-19 Vaccine
New COVID-19 VaccineNew COVID-19 Vaccine
New COVID-19 Vaccine
EMMAIntl
 
Men’s Health Week: Depression
Men’s Health Week: DepressionMen’s Health Week: Depression
Men’s Health Week: Depression
EMMAIntl
 
Celebrating Pride Month at EMMA International
Celebrating Pride Month at EMMA InternationalCelebrating Pride Month at EMMA International
Celebrating Pride Month at EMMA International
EMMAIntl
 
Growth and Integration of ML/AI in Biotech
Growth and Integration of ML/AI in BiotechGrowth and Integration of ML/AI in Biotech
Growth and Integration of ML/AI in Biotech
EMMAIntl
 
Using QFD for Medical Device Development
Using QFD for Medical Device DevelopmentUsing QFD for Medical Device Development
Using QFD for Medical Device Development
EMMAIntl
 
The Appeal and Fears of Digital Health
The Appeal and Fears of Digital HealthThe Appeal and Fears of Digital Health
The Appeal and Fears of Digital Health
EMMAIntl
 
Immune Systems After the COVID-19 Pandemic
Immune Systems After the COVID-19 PandemicImmune Systems After the COVID-19 Pandemic
Immune Systems After the COVID-19 Pandemic
EMMAIntl
 
Stability Testing Requirements for Pharmaceuticals
Stability Testing Requirements for PharmaceuticalsStability Testing Requirements for Pharmaceuticals
Stability Testing Requirements for Pharmaceuticals
EMMAIntl
 
Staying Healthy During COVID-19
Staying Healthy During COVID-19Staying Healthy During COVID-19
Staying Healthy During COVID-19
EMMAIntl
 
A History of Reproductive Health
A History of Reproductive HealthA History of Reproductive Health
A History of Reproductive Health
EMMAIntl
 
Electronic Signatures Under 21CFR§11
Electronic Signatures Under 21CFR§11Electronic Signatures Under 21CFR§11
Electronic Signatures Under 21CFR§11
EMMAIntl
 
Considerations for Biocompatibility Evaluation
Considerations for Biocompatibility EvaluationConsiderations for Biocompatibility Evaluation
Considerations for Biocompatibility Evaluation
EMMAIntl
 
Restoring the Earth for a Healthier Future
Restoring the Earth for a Healthier FutureRestoring the Earth for a Healthier Future
Restoring the Earth for a Healthier Future
EMMAIntl
 

More from EMMAIntl (20)

Cartilage Regeneration Techniques
Cartilage Regeneration TechniquesCartilage Regeneration Techniques
Cartilage Regeneration Techniques
 
Stability Testing of Pharmaceuticals and Supplements
Stability Testing of Pharmaceuticals and SupplementsStability Testing of Pharmaceuticals and Supplements
Stability Testing of Pharmaceuticals and Supplements
 
Intolerance vs. Allergy
Intolerance vs. AllergyIntolerance vs. Allergy
Intolerance vs. Allergy
 
Material Science in MedTech
Material Science in MedTechMaterial Science in MedTech
Material Science in MedTech
 
Investigating Ketamine for Parkinson’s Disease
Investigating Ketamine for Parkinson’s DiseaseInvestigating Ketamine for Parkinson’s Disease
Investigating Ketamine for Parkinson’s Disease
 
Aduhelm, an Accelerated Approval for Alzheimer’s
Aduhelm, an Accelerated Approval for Alzheimer’sAduhelm, an Accelerated Approval for Alzheimer’s
Aduhelm, an Accelerated Approval for Alzheimer’s
 
World Blood Donor Day 2021
World Blood Donor Day 2021World Blood Donor Day 2021
World Blood Donor Day 2021
 
New COVID-19 Vaccine
New COVID-19 VaccineNew COVID-19 Vaccine
New COVID-19 Vaccine
 
Men’s Health Week: Depression
Men’s Health Week: DepressionMen’s Health Week: Depression
Men’s Health Week: Depression
 
Celebrating Pride Month at EMMA International
Celebrating Pride Month at EMMA InternationalCelebrating Pride Month at EMMA International
Celebrating Pride Month at EMMA International
 
Growth and Integration of ML/AI in Biotech
Growth and Integration of ML/AI in BiotechGrowth and Integration of ML/AI in Biotech
Growth and Integration of ML/AI in Biotech
 
Using QFD for Medical Device Development
Using QFD for Medical Device DevelopmentUsing QFD for Medical Device Development
Using QFD for Medical Device Development
 
The Appeal and Fears of Digital Health
The Appeal and Fears of Digital HealthThe Appeal and Fears of Digital Health
The Appeal and Fears of Digital Health
 
Immune Systems After the COVID-19 Pandemic
Immune Systems After the COVID-19 PandemicImmune Systems After the COVID-19 Pandemic
Immune Systems After the COVID-19 Pandemic
 
Stability Testing Requirements for Pharmaceuticals
Stability Testing Requirements for PharmaceuticalsStability Testing Requirements for Pharmaceuticals
Stability Testing Requirements for Pharmaceuticals
 
Staying Healthy During COVID-19
Staying Healthy During COVID-19Staying Healthy During COVID-19
Staying Healthy During COVID-19
 
A History of Reproductive Health
A History of Reproductive HealthA History of Reproductive Health
A History of Reproductive Health
 
Electronic Signatures Under 21CFR§11
Electronic Signatures Under 21CFR§11Electronic Signatures Under 21CFR§11
Electronic Signatures Under 21CFR§11
 
Considerations for Biocompatibility Evaluation
Considerations for Biocompatibility EvaluationConsiderations for Biocompatibility Evaluation
Considerations for Biocompatibility Evaluation
 
Restoring the Earth for a Healthier Future
Restoring the Earth for a Healthier FutureRestoring the Earth for a Healthier Future
Restoring the Earth for a Healthier Future
 

Recently uploaded

NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTNURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
blessyjannu21
 
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell
 
Hypotension and role of physiotherapy in it
Hypotension and role of physiotherapy in itHypotension and role of physiotherapy in it
Hypotension and role of physiotherapy in it
Vishal kr Thakur
 
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
5sj7jxf7
 
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdf
CHAPTER 1 SEMESTER V  COMMUNICATION TECHNIQUES FOR CHILDREN.pdfCHAPTER 1 SEMESTER V  COMMUNICATION TECHNIQUES FOR CHILDREN.pdf
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdf
Sachin Sharma
 
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DR Jag Mohan Prajapati
 
Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.
Vishal kr Thakur
 
Vicarious movements or trick movements_AB.pdf
Vicarious movements or trick movements_AB.pdfVicarious movements or trick movements_AB.pdf
Vicarious movements or trick movements_AB.pdf
Arunima620542
 
National Rural Health Mission(NRHM).pptx
National Rural Health Mission(NRHM).pptxNational Rural Health Mission(NRHM).pptx
National Rural Health Mission(NRHM).pptx
Jyoti Chand
 
leprosy Case detection and diagnosis.pptx
leprosy Case detection and diagnosis.pptxleprosy Case detection and diagnosis.pptx
leprosy Case detection and diagnosis.pptx
habtegirma
 
English Drug and Alcohol Commissioners June 2024.pptx
English Drug and Alcohol Commissioners June 2024.pptxEnglish Drug and Alcohol Commissioners June 2024.pptx
English Drug and Alcohol Commissioners June 2024.pptx
MatSouthwell1
 
NEEDLE STICK INJURY - JOURNAL CLUB PRESENTATION - DR SHAMIN EABENSON
NEEDLE STICK INJURY - JOURNAL CLUB PRESENTATION - DR SHAMIN EABENSONNEEDLE STICK INJURY - JOURNAL CLUB PRESENTATION - DR SHAMIN EABENSON
NEEDLE STICK INJURY - JOURNAL CLUB PRESENTATION - DR SHAMIN EABENSON
SHAMIN EABENSON
 
nhs fpx 4000 assessment 4 analyzing a current health care problem or issue.pdf
nhs fpx 4000 assessment 4 analyzing a current health care problem or issue.pdfnhs fpx 4000 assessment 4 analyzing a current health care problem or issue.pdf
nhs fpx 4000 assessment 4 analyzing a current health care problem or issue.pdf
Carolyn Harker
 
Data-Driven Dispensing- Rise of AI in Pharmacies.pdf
Data-Driven Dispensing- Rise of AI in Pharmacies.pdfData-Driven Dispensing- Rise of AI in Pharmacies.pdf
Data-Driven Dispensing- Rise of AI in Pharmacies.pdf
Jasper Colin
 
Friendly Massage in Ajman - Malayali Kerala Spa Ajman
Friendly Massage in Ajman - Malayali Kerala Spa AjmanFriendly Massage in Ajman - Malayali Kerala Spa Ajman
Friendly Massage in Ajman - Malayali Kerala Spa Ajman
Malayali Kerala Spa Ajman
 
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
xkute
 
muscluskeletal assessment...........pptx
muscluskeletal assessment...........pptxmuscluskeletal assessment...........pptx
muscluskeletal assessment...........pptx
RushikeshHange1
 
一比一原版(USF毕业证)旧金山大学毕业证如何办理
一比一原版(USF毕业证)旧金山大学毕业证如何办理一比一原版(USF毕业证)旧金山大学毕业证如何办理
一比一原版(USF毕业证)旧金山大学毕业证如何办理
40fortunate
 
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
Vedanta A
 
Sectional dentures for microstomia patients.pptx
Sectional dentures for microstomia patients.pptxSectional dentures for microstomia patients.pptx
Sectional dentures for microstomia patients.pptx
SatvikaPrasad
 

Recently uploaded (20)

NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTNURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPT
 
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
 
Hypotension and role of physiotherapy in it
Hypotension and role of physiotherapy in itHypotension and role of physiotherapy in it
Hypotension and role of physiotherapy in it
 
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
 
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdf
CHAPTER 1 SEMESTER V  COMMUNICATION TECHNIQUES FOR CHILDREN.pdfCHAPTER 1 SEMESTER V  COMMUNICATION TECHNIQUES FOR CHILDREN.pdf
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdf
 
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
 
Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.
 
Vicarious movements or trick movements_AB.pdf
Vicarious movements or trick movements_AB.pdfVicarious movements or trick movements_AB.pdf
Vicarious movements or trick movements_AB.pdf
 
National Rural Health Mission(NRHM).pptx
National Rural Health Mission(NRHM).pptxNational Rural Health Mission(NRHM).pptx
National Rural Health Mission(NRHM).pptx
 
leprosy Case detection and diagnosis.pptx
leprosy Case detection and diagnosis.pptxleprosy Case detection and diagnosis.pptx
leprosy Case detection and diagnosis.pptx
 
English Drug and Alcohol Commissioners June 2024.pptx
English Drug and Alcohol Commissioners June 2024.pptxEnglish Drug and Alcohol Commissioners June 2024.pptx
English Drug and Alcohol Commissioners June 2024.pptx
 
NEEDLE STICK INJURY - JOURNAL CLUB PRESENTATION - DR SHAMIN EABENSON
NEEDLE STICK INJURY - JOURNAL CLUB PRESENTATION - DR SHAMIN EABENSONNEEDLE STICK INJURY - JOURNAL CLUB PRESENTATION - DR SHAMIN EABENSON
NEEDLE STICK INJURY - JOURNAL CLUB PRESENTATION - DR SHAMIN EABENSON
 
nhs fpx 4000 assessment 4 analyzing a current health care problem or issue.pdf
nhs fpx 4000 assessment 4 analyzing a current health care problem or issue.pdfnhs fpx 4000 assessment 4 analyzing a current health care problem or issue.pdf
nhs fpx 4000 assessment 4 analyzing a current health care problem or issue.pdf
 
Data-Driven Dispensing- Rise of AI in Pharmacies.pdf
Data-Driven Dispensing- Rise of AI in Pharmacies.pdfData-Driven Dispensing- Rise of AI in Pharmacies.pdf
Data-Driven Dispensing- Rise of AI in Pharmacies.pdf
 
Friendly Massage in Ajman - Malayali Kerala Spa Ajman
Friendly Massage in Ajman - Malayali Kerala Spa AjmanFriendly Massage in Ajman - Malayali Kerala Spa Ajman
Friendly Massage in Ajman - Malayali Kerala Spa Ajman
 
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
一比一原版(UoA毕业证)昆士兰科技大学毕业证如何办理
 
muscluskeletal assessment...........pptx
muscluskeletal assessment...........pptxmuscluskeletal assessment...........pptx
muscluskeletal assessment...........pptx
 
一比一原版(USF毕业证)旧金山大学毕业证如何办理
一比一原版(USF毕业证)旧金山大学毕业证如何办理一比一原版(USF毕业证)旧金山大学毕业证如何办理
一比一原版(USF毕业证)旧金山大学毕业证如何办理
 
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
 
Sectional dentures for microstomia patients.pptx
Sectional dentures for microstomia patients.pptxSectional dentures for microstomia patients.pptx
Sectional dentures for microstomia patients.pptx
 

How the FDA Regulates the Advertising of Medical Devices

  • 1. How the FDA Regulates the Advertising of Medical Devices By: Nikita Angane FDA regulates the labeling and advertising of all pharmaceutical products; however, it regulates the labeling of all medical devices and the advertising of only restricted devices. Currently, only two types of class I & class II devices fall under the restricted devices category. One is hearing aids and the other is Analyte Specific Reagents (ASRs). FDA may designate the restricted device category for devices that are approved via the PMA route. Thus, most of the class III devices are restricted, while no class I or class II devices are restricted except for the hearing aids and ASRs.i FDA, however, does have the authority to regulate the advertising of the non-restricted devices related to its intended use. FDA issued several draft guidance documents in the past but has not made any of them a final rule until now. The said draft guidance documents are: 1. Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devicesii 2. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices iii 3. Presenting Risk Information in Prescription Drug and Medical Device Promotioniv The first guidance is about how to communicate the risk information about the device/drug on media sites that have character space limitations such as twitter, which has a limit of about 280 characters. The second guidance document applies to information published by third parties on the social media/internet regardless of that information being presented on the company’s own internet platforms or third-party platforms. The third guidance document describes how the FDA evaluates the promotional pieces of prescription drugs and medical devices for the disclosure of the risk information to ensure that the benefits and the risks are accurate and not misleading. The recommendations in these guidance documents apply to the promotional materials directed to the consumers, as well as healthcare professionals. However, these draft guidance documents have not become a final rule.
  • 2. Page 2 of 2 i Hyman, Phelps & McNamara (2014) What Legal Authority Does FDA Have to Regulate Medical Device Promotion on Internet Social Media Platforms? Retrieved on 07/24/2019 from http://www.fdalawblog.net/2014/09/what- legal-authority-does-fda-have-to-regulate-medical-device-promotion-on-internet-social-media-pla/ ii FDA (June 2014) Guidancefor Industry Internet/Social Media Platforms with Character SpaceLimitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices retrieved on 07/24/2019 fromhttps://www.fda.gov/media/88551/download iii FDA (June 2014) Guidancefor Industry Internet/Social Media Platforms:Correcting Independent Third-Party Misinformation AboutPrescription Drugs and Medical Devices retrieved on 07/24/2019 from https://www.fda.gov/media/88545/download iv FDA (May 2009) Guidancefor Industry Presenting Risk Information in Prescription Drugand Medical Device Promotion retrieved on 07/24/2019 from https://www.fda.gov/media/76269/download