Three pillars of compliance govern every piece of content IronPost Media creates: FDA Fair Balance, Off-Label Prevention, and Audit-Ready Archiving. Here's exactly how each one works.
Every benefit claim must be balanced with risk information. No exceptions.
If a post mentions a device benefit (e.g., "improved oxygenation"), it must include corresponding risk information (e.g., contraindications, potential adverse events). We match benefit language with proportional risk disclosure, meeting FDA's fair balance requirement under 21 CFR 801 and the FD&C Act.
Every promotional post includes a direct link to the device's full prescribing information or IFU (Instructions for Use). On character-limited platforms like X, we use link-in-bio strategies to ensure ISI is always one click away.
All content claims are verified against the device's 510(k) summary, cleared indications for use, and approved marketing materials. We never extrapolate beyond what the FDA has cleared. If it's not in the labeling, it's not in the post.
LinkedIn long-form allows inline risk/benefit disclosure. X requires compressed fair balance with ISI links. Instagram needs caption-based disclosure plus story highlight for full safety info. We format compliance to fit the platform without compromising substance.
Any comparative language (e.g., "faster recovery," "easier to use") requires head-to-head clinical evidence. We flag and remove unsupported comparatives before publishing. If the data doesn't support it, the post doesn't say it.
Content must never promote use beyond FDA-cleared indications.
Every piece of content starts with the device's cleared indications for use as a constraint. Our content process begins by defining what we CAN say based on the labeling, then creates within those boundaries. No creative freedom overrides regulatory limits.
Hashtags can imply off-label use (e.g., tagging a respiratory device with #SleepApnea when it's only cleared for supplemental oxygen). We screen every hashtag and keyword against approved indications before publishing.
If a healthcare provider or patient shares content that implies off-label use, we never amplify, repost, or engage with it. Our protocol includes monitoring mentions and escalating off-label UGC to the regulatory team for appropriate response.
Paid social campaigns are targeted to appropriate healthcare professional audiences based on the device's intended user population. We never target patient populations for prescription-only devices or audiences outside the cleared indication.
Social media comments can trigger off-label discussions. We monitor comments on every post and have predefined response templates that redirect off-label questions to medical affairs or the prescribing information, without engaging in off-label promotion.
Every post is archived with full context for regulatory inspection.
Every published post is captured as a timestamped screenshot with metadata: platform, publish date/time, audience targeting parameters, and engagement metrics at time of archival. This creates a forensic record that matches FDA expectations for promotional material documentation.
Each piece of content moves through a documented approval workflow: copywriter draft, regulatory review, medical/legal review, and final sign-off. Every stage is timestamped with the reviewer's identity and any changes made. The full chain is available for audit.
If a post is edited or updated after publishing, both the original and revised versions are archived. The change reason, approver, and timestamp are documented. No content is ever deleted from the archive -- even rejected drafts are preserved for audit trail completeness.
If a social media comment or message contains an adverse event report, our protocol documents: the original report, time of discovery, escalation to pharmacovigilance/quality, and the response provided. This meets FDA's post-market surveillance requirements for social media channels.
All archived content is retained according to FDA record retention requirements (minimum 2 years after last distribution for 510(k) devices). Archives are stored securely with access controls and are exportable in standard formats for regulatory submissions or inspections.
We build custom compliance playbooks for every client based on their device classification, regulatory history, and marketing goals.