What are the recent regulatory updates from the FDA and FTC for medical device marketing?

The FDA and FTC have intensified oversight with initiatives like the FTC's Health Products Compliance Guidance and the FDA's 2023 regulatory updates, focusing on precise product claims and clear advertising language.

Why is compliance with FDA and FTC standards important for medical device marketers?

Compliance prevents expensive recalls, safeguards public trust, and avoids enforcement actions, making it a strategic necessity beyond just a legal requirement.

What are common pitfalls in medical device marketing compliance?

Common pitfalls include translation mismatches in multilingual ads, omitted alt text for digital ads, and mishandling HTML terms, which can lead to compliance orders and fines.

How can companies ensure their marketing claims are truthful and balanced?

Companies should adhere to the principle of fair balance, presenting both benefits and risks equitably, and ensure claims are verifiable and compliant with federal regulations.

What strategies can help maintain compliance in medical device marketing?

Implementing continuous audits, investing in specialized training, and developing comprehensive asset management systems can help maintain compliance with FDA and FTC guidelines.

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