Check out our most recent article featured in FDLI >

Call for a Consultation 484-414-4093 Schedule Online
By: Kendall PC
July 5, 2026

The FDA Is Watching Your AI—Is Your Compliance Program Ready?

Artificial intelligence is transforming the life sciences industry. Companies are leveraging AI to draft regulatory submissions, analyze clinical trial data, support Medical Affairs, automate pharmacovigilance activities, develop marketing content, improve quality management systems, and streamline commercialization efforts.

While these innovations offer tremendous opportunities, they also introduce significant regulatory and legal risks.

Many executives mistakenly assume that because the FDA has not issued comprehensive AI regulations governing every internal business process, companies have broad discretion in how AI is used. However, the FDA has consistently emphasized that regulated companies—not AI vendors—remain responsible for the accuracy, reliability, and integrity of regulated activities.

As AI becomes embedded across pharmaceutical, biotechnology, medical device, and digital health organizations, regulators increasingly expect companies to implement governance frameworks that demonstrate appropriate oversight, validation, documentation, and accountability.

AI Is No Longer an IT Issue

Historically, AI implementation was viewed primarily as a technology initiative. Today, it is a compliance issue.

Organizations are now using generative AI to:

  • Draft SOPs
  • Prepare clinical study documentation
  • Generate regulatory correspondence
  • Create promotional content
  • Summarize scientific literature
  • Assist Medical Science Liaisons
  • Support quality investigations
  • Evaluate adverse event trends
  • Develop training materials

Each of these activities may fall within existing FDA regulations, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practices (GDP), HIPAA requirements, or healthcare fraud and abuse laws.

If AI-generated information is inaccurate—or inadequately reviewed—the regulatory consequences can be significant.

Five Questions Every Executive Should Ask

1. Do We Have an AI Governance Policy?

Many companies have adopted AI tools without creating policies governing their use. An effective AI governance policy should address:

  • Permitted AI applications
  • Prohibited uses
  • Human review requirements
  • Confidential information safeguards
  • Documentation expectations
  • Vendor approval processes
  • Record retention

Without clear governance, organizations expose themselves to inconsistent practices across departments.

2. Who Reviews AI Output?

Generative AI frequently produces convincing—but inaccurate—responses. Companies should establish documented human review procedures before AI-generated materials are used for:

  • Regulatory submissions
  • Promotional review
  • Medical information
  • Scientific publications
  • Clinical documentation
  • Standard operating procedures

Human oversight remains essential.

3. Have We Evaluated Vendor Risk?

Using an AI platform means sharing company information with a third party. Before deploying any AI solution, organizations should evaluate:

  • Data security
  • HIPAA compliance
  • Confidentiality protections
  • Intellectual property ownership
  • Data retention practices
  • Vendor contractual protections

This assessment should involve Legal, Compliance, Information Security, and Privacy personnel.

4. Are Employees Trained?

Many organizations have implemented AI without training employees on acceptable use. Training should explain:

  • Appropriate prompts
  • Confidential data restrictions
  • Hallucination risks
  • Documentation requirements
  • Approval workflows
  • Reporting obligations

Education significantly reduces organizational risk.

5. Could We Defend Our AI Practices During an FDA Inspection?

FDA investigators increasingly evaluate documentation, decision-making, and quality systems. If asked how AI contributed to regulated activities, companies should be prepared to demonstrate:

  • Governance policies
  • Validation procedures
  • Training records
  • Review processes
  • Audit trails
  • Corrective actions

Preparation before an inspection is substantially easier than responding after deficiencies are identified.

AI Governance Should Be Cross-Functional

Successful AI governance requires collaboration among:

  • Legal
  • Compliance
  • Regulatory Affairs
  • Medical Affairs
  • Quality
  • Information Technology
  • Privacy
  • Commercial Leadership

Each function brings unique expertise that helps identify and mitigate risk.

Practical Next Steps

Organizations should consider:

  • Conducting an AI compliance risk assessment
  • Developing enterprise AI governance policies
  • Updating SOPs
  • Revising promotional review procedures
  • Evaluating vendor agreements
  • Training employees
  • Monitoring evolving FDA expectations

Companies that proactively address these issues will be better positioned as regulatory expectations continue to evolve.

How Kendall PC Can Help

At Kendall PC, we advise pharmaceutical, biotechnology, medical device, digital health, and healthcare companies on practical regulatory compliance strategies that support innovation without sacrificing compliance.

Our attorneys assist clients with:

Artificial intelligence will continue to reshape healthcare—but organizations that combine innovation with strong governance will be best positioned for long-term success.

Contact Kendall PC

If your organization is implementing AI across regulatory, medical, commercial, or quality functions, now is the time to evaluate whether your compliance program is prepared for the next generation of FDA oversight.

Contact Kendall PC today to schedule a consultation with our experienced regulatory attorneys.

Related Practice Areas: FDA Regulatory Services | Healthcare Compliance | Medical Device Law | Pharmaceutical Law