Marketing Claims For Medical Devices

How to Study and Market Your Device | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device

The marketing pathways include: Premarket Notification (510 (k)), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Use Exemption...

Health Claims | Federal Trade Commission

https://www.ftc.gov/business-guidance/advertising-marketing/health-claims

Gut Check: A Reference Guide for Media on Spotting False Weight Loss Claims To help media outlets spot false weight loss representations — "gut check" claims — the FTC …

Reporting Allegations of Regulatory Misconduct | FDA

https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct

FDA Regulation of Medical Device …

https://www.corporatecomplianceinsights.com/fda-regulation-of-medical-device-advertising-and-promotion/

Updated 2018. There are tens of thousands of medical devices being advertised and promoted in the …

Advertising and Marketing Claims - Cohen Healthcare Law

https://cohenhealthcarelaw.com/fda-ftc-law/advertising-and-marketing-claims/

For most disease-related representations – especially claims as serious as Zika prevention or risk reduction – that means well-controlled human clinical testing. The above are …

Marketing for Medical Devices: 6 Keys to Increase …

https://www.responsify.com/marketing-for-medical-devices/

The global digital health market has been approximated to bring in earnings of $536.6 billion by the end of 2025 from $196.3 billion in 2017, according to research by Transparency …

FDA Marketing Claims - What is and isn't allowed

https://elsmar.com/elsmarqualityforum/threads/fda-marketing-claims-what-is-and-isnt-allowed.67165/

We never make any claim that the device can be used outside the intended use in the 510 (k). As far as I'm aware as long as we aren't changing the intended use of …

Advertising of Medical Devices and Principles of Claim …

https://biomedgrid.com/fulltext/volume12/advertising-of-medical-devices-and-principles-of-claim.001777.php

For the advertising of medical devices, all mentioned statements, results and claims must be verifiable and evidenced by data, as well as properly documented. …

Promotion and Advertising of Medical Devices - ehcca.com

http://www.ehcca.com/presentations/fdasymposium4/wolf_2.pdf

disseminated of scientific and medical information on unapproved uses of approved or cleared devices Federal Food, Drug and Cosmetic Act and implementing regulations …

How to best set claims for a medical device

https://www.avanti-europe.ch/how-to-best-set-claims-for-a-medical-device/

As article 7 of the MDR 2017/745 demands, claims refer to the device’s intended purpose, safety and performance. In order to set a claim, therefore, the intended purpose, the …