FDA Myths Versus Truths: What You Really Need to Know

When it comes to the U.S. Food and Drug Administration (FDA), myths and misconceptions abound—even among experienced industry professionals. From assumptions about clinical trial requirements to misunderstandings about the FDA’s enforcement power, these myths can lead to costly compliance missteps. In a recent ComplianceQuest-sponsored webinar, regulatory veteran Judith Meritz unpacked 14 of the most common myths and clarified the agency’s real role in the product lifecycle.

Here’s what you really need to know.

Myth #1: All Drugs and Devices Require Clinical Trials

This is one of the most persistent myths. While clinical trials are required for high-risk (Class III) medical devices, they are not mandatory for all products. Many Class II (moderate-risk) devices can be cleared through the 510(k) pathway by demonstrating substantial equivalence to existing products. The same goes for some pharmaceutical applications, for which existing data may support.

Truth: FDA assesses product risk and applies varying levels of scrutiny accordingly. Clinical trials are just one tool in the toolbox.

Myth #2: FDA Dictates Manufacturing Processes

Many believe the FDA tells companies exactly how to make their products. That’s not the case. The FDA is primarily interested in whether companies control their processes and adhere to current good manufacturing practices (CGMPs). They do not micromanage how you implement those practices.

Truth: The FDA requires robust, documented quality systems but not a prescribed manufacturing method.

Myth #3: FDA Orders Most Recalls

Contrary to popular belief, the vast majority of recalls are initiated voluntarily by manufacturers. While the FDA can request or pressure a company into recalling a product, they rarely issue formal recall orders.

Truth: Most recalls are voluntary, and being proactive is in a company’s best interest. Always state that the recall is “voluntary” in your customer communications to reinforce trust and accountability.

Myth #4: Being Friendly With Inspectors Wins Favor

Offering coffee and donuts doesn’t build regulatory goodwill. What matters is demonstrating preparedness, transparency, and SOP compliance. Judith recommends beginning FDA inspections with a binder of key policies to set a professional and confident tone.

Truth: Trust is built through compliance, not charm.

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Myth #5: FDA Can Sue Companies on Its Own

The FDA cannot independently sue a company. It relies on the Department of Justice (DOJ) to take legal action, similar to how other regulatory agencies, like the EPA, function.

Truth: The FDA partners with the DOJ when enforcement escalates to litigation, particularly in cases involving fraud or major public health threats.

Myth #6: FDA Guidance Documents Are Law

Guidance documents express the FDA’s current thinking but are not legally binding. While companies should have good reason to deviate from them, these documents do not carry the force of law and are not subject to the formal rule-making process.

Truth: Guidance is just that—guidance. However, following it closely is often a best practice, especially if it’s been around for years.

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Myth #7: FDA Bans Off-Label Use

Physicians can legally prescribe drugs or use devices for off-label purposes. What’s prohibited is manufacturers promoting off-label uses, including marketing materials, website content, or sales presentations.

Truth: Doctors can use products off-label, but manufacturers cannot promote those uses.

Myth #8: Adverse Event Reporting Is Just for the FDA’s Sake

Timely reporting of complaints and adverse events isn't just for the benefit of regulators—it’s essential for patient safety. Programs like MedWatch help gather real-world data and identify product failures or systemic risks.

Truth: Adverse event data informs both regulatory oversight and product improvement.

Myth #9: CAPA and Complaint Handling Are Rarely Cited

Incorrect. CAPA (Corrective and Preventive Actions) and complaint handling are among the most commonly cited violations in FDA Form 483s and warning letters. Too often, companies cite “operator error” and retrain employees without solving root causes.

Truth: FDA expects root cause analysis and systemic solutions, not superficial fixes.

Myth #10: FDA Accepts Foreign Regulatory Approvals

Despite globalization, the FDA does not accept approvals from the EU or other foreign agencies as substitutes for its assessments. It may consider foreign data, but insists on applying its standards.

Truth: FDA is the global gold standard and operates independently.

Myth #11: Post-Market Surveillance Is Secondary to Clinical Data

Post-market surveillance often reveals safety or performance issues that clinical trials didn’t catch. It provides critical real-world insights, especially in diverse populations and variable conditions.

Truth: Surveillance after launch is essential for ensuring ongoing safety and efficacy.

Myth #12: CAPA Must Be Completed in 10 Days

There is no fixed deadline like “10 days” for CAPA closure. Timeliness is judged based on risk-benefit analysis and mitigation measures. Complex issues may take longer if interim controls are in place.

Truth: CAPA timelines must be reasonable, not rushed.

Myth #13: FDA Approves Cosmetics

The FDA doesn’t approve cosmetic products, except for certain color additives, before they go to market. It regulates labeling, safety, and ingredients under the FD&C Act and the Fair Packaging and Labeling Act.

Truth: Most cosmetics hit the market without pre-approval.

Final Takeaway: The FDA Isn’t Out to Get You

Many companies fear the FDA unnecessarily. The agency’s role is to ensure safe, effective products and consistent quality, not penalizing innovation or growth. Companies prioritizing compliance, transparency, and risk management tend to have smoother regulatory interactions.

If your team understands the fundamental rules—and the myths—you’ll be far better prepared for inspections, submissions, and post-market surveillance.

Sponsored by ComplianceQuest

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