Turn FDA Language Into Content Buyers Actually Understand

Your FDA clearance letter is a thing of beauty. It’s pages of clinical endpoints, bench testing summaries, and carefully worded claims about substantial equivalence. You frame it on the wall. You forward it to investors. Then, you copy-paste it into your marketing materials and watch your buyers’ eyes glaze over.

FDA language is written for regulators, not for clinicians, purchasing committees, or hospital CFOs. If your content sounds like a 510(k) summary, you’ll lose attention before you’ve even made your case. Buyers need clarity, context, and confidence, not regulatory fine print.

Here’s how to turn your FDA clearance or approval into content that buyers actually understand, trust, and act on.

Step 1: Start With the Claims You’re Allowed to Make

FDA clearance defines what you can say, but it doesn’t have to define how you say it.

Pull your Indications for Use statement and 510(k)/PMA summary and highlight the key claims you’re allowed to make. Then reframe them into plain language:

• FDA language: “Device is indicated for use in the approximation of soft tissue.”

• Buyer language: “Our device closes surgical incisions faster, with fewer steps, and helps reduce wound complications.”

You stay compliant, but you make the benefit clear.

Pro Tip: Run all marketing copy through your RA/QA team before publishing. Compliance is still king. But compliance doesn’t mean boring.

Step 2: Translate Bench Data Into Real-World Impact

Your 510(k) probably lists bench tests like tensile strength, burst pressure, or electrical safety. Buyers don’t care about numbers in isolation. They care what those numbers mean.

Instead of:

“Device demonstrated 10% higher tensile strength compared to the predicate.”

Try:

“Our device holds tissue more securely, which means fewer re-suturing events and more predictable healing.”

Tie every data point to something that matters in the OR, ICU, or cath lab, like time saved, staff steps reduced, or patient outcomes improved.

Step 3: Humanize Your Clinical Evidence

Your summary might include phrases like “non-inferiority demonstrated with a p-value of <0.05.” Great for the FDA. Not great for a busy clinician on a coffee break.

• Translate statistical significance into plain language: “Clinical trial results showed outcomes as good as or better than the current standard of care.”

• Pull out sample size and site info: Buyers trust large, multi-center studies more than single-site pilots.

• Use visuals: Graphs, charts, and infographics make data digestible.

Example: A cardiology device company turned its entire pivotal trial into a one-page infographic showing complication reduction, procedure time saved, and patient survival rates and saw a 35% increase in demo requests.

Step 4: Explain the Regulatory Milestone

Many buyers don’t actually know the difference between 510(k) clearance, De Novo classification, and PMA approval. Explain what your milestone means for them:

• 510(k): “FDA confirmed our device is substantially equivalent to other cleared devices, but with the design improvements you’ve been waiting for.”

• PMA: “Our device has been through the most rigorous FDA review process available, including clinical trials that prove safety and effectiveness.”

• De Novo: “FDA created a new classification just for our technology, recognizing it as a first-of-its-kind innovation.”

Regulatory milestones reassure buyers that your device isn’t experimental. It’s cleared for clinical use and backed by evidence.

Step 5: Speak to Workflow, Not Just Safety

Regulatory submissions focus on safety and effectiveness. Buyers focus on workflow, throughput, and staffing. Translate your clearance into operational impact:

• “Faster device setup means turning rooms quicker.”

• “Fewer steps per procedure reduces nurse fatigue.”

• “Compact footprint frees up space for other equipment.”

These points turn a regulatory document into a sales enabler.

Step 6: Build Buyer-Friendly Tools

Regulatory text is static. Turn it into tools buyers can actually use:

• ROI calculators: Let CFOs plug in case volumes and see savings.

• Procedure guides: Show clinicians step-by-step workflows with your device.

• Comparison charts: Line up your claims against the predicate device clearly, visually, and with your differentiators bolded.

  
  

Step 7: Layer in Storytelling

Numbers persuade the rational brain, and stories convince the emotional brain. Share anonymized patient cases or pilot site success stories:

“At one pilot hospital, adopting our device reduced average procedure time by 12 minutes, freeing up enough OR time for an additional case per day.”

Stories stick, and they make your data memorable.

Step 8: Keep the Tone Professional but Approachable

Don’t strip out technical credibility. Clinicians want to know you know your stuff. However, avoid alienating them with dense, regulatory prose. Use active voice, short sentences, and second person (“you,” “your team”) to make content feel like a conversation, not a compliance seminar.

Step 9: Train Your Sales Team to Use It

Even the best buyer-facing content is wasted if your sales team just hands over the FDA summary. Train reps to speak about clearance in plain language, focusing on clinical value, workflow impact, and cost justification.

Step 10: Make RA/QA Your Partner, Not Your Bottleneck

Content writers and marketers sometimes avoid RA/QA until the last minute, resulting in last-minute rewrites. Involve them early so you know which claims are safe to make and which need clinical evidence to support. When RA is an ally, you can be creative without risking warning letters.

Your FDA clearance or approval is the foundation of your credibility, but it’s not a brochure. To sell effectively, you have to bridge the gap between regulatory language and clinical relevance. 

At Borrowed Pen, we help medical device companies turn FDA submissions into buyer-friendly stories that actually move the needle. Work with us, and we’ll make sure your clearance isn’t just a regulatory milestone. It’s a marketing asset that drives adoption.