US Regulatory Due Diligence for Pharma and Device Companies Expanding into America

FDA regulatory due diligence involves reviewing the key regulatory requirements before entering the United States market. A structured review helps identify compliance gaps, improve regulatory readiness and support successful regulatory submission and market entry.

Assessing US FDA Market Entry Requirements

Companies entering the US market must meet all specified FDA requirements. They need to identify the FDA regulatory pathway applicable to their product as part of an effective US market entry regulatory strategy. Pharmaceutical products may require an Investigational New Drug Application, New Drug Application, Abbreviated New Drug Application or Biologics License Application depending on the product and stage of development. For certain over-the-counter medicines, companies may instead be able to market products under an applicable over-the-counter monograph when the product meets its specified requirements for ingredients, dosage, formulation, labelling, and other conditions .¹

For Medical Devices, companies should determine the device classification based on its level of risk and identify the suitable marketing pathway, which may include 510(k) Premarket Notification, De Novo Classification Request, or Premarket Approval, while some devices may be exempt from premarket submission. Due diligence should also verify whether the product has met applicable premarket, clinical or non-clinical evidence, labelling, establishment registration, device listing, and other regulatory control requirements before US marketing .²

Evaluating Quality, Manufacturing and Registration Compliance

Quality and manufacturing compliance is an important part of regulatory due diligence when assessing a company’s readiness to enter the US market. A review should determine whether the company’s quality systems, manufacturing controls and establishment registrations meet the requirements applicable to its products.³ 

Some key points are as follows: 

• For Medical Device manufacturers, compliance is essential with the Quality Management System Regulation (QMSR) which became effective on February 2, 2026, and incorporates ISO 13485:2016 into the FDA’s quality system framework.³ 

• Quality system review must consider controls covering device design, development, manufacturing and complaint investigations to support compliance throughout the product lifecycle.⁴ 
• For Medical Devices, it is important to verify establishment registration and device listing requirements for facilities involved in the production and distribution of devices intended for use in the United States.⁵ 
• For pharmaceutical companies, domestic and foreign establishments that manufacture, repack or relabel drug products for the US market must register with the FDA and list their commercially marketed drug products. 

Reviewing Clinical, Safety and Regulatory Evidence

A regulatory due diligence review should assess whether the clinical and scientific evidence supporting a product is adequate for its intended US regulatory pathway.⁶ The review should also identify whether additional clinical evidence, testing or regulatory requirements may need to be addressed before market entry.²

Some key points are as follows:

• For Pharmaceutical products, companies should review clinical evidence demonstrating that the product is safe and effective for its intended use before submitting the relevant application to the FDA.⁶ 
• For Medical Devices, the type and extent of clinical evidence required may depend on the device classification and the selected premarket pathway. 
• Certain Medical Devices may require clinical studies supported by an Investigational Device Exemption and approval from an appropriate Institutional Review Board before the study begins.² 
• Companies should also assess whether submitted evidence adequately supports the FDA’s evaluation of product safety and effectiveness for the intended population and use.⁶ 

Assessing Labelling and Product Information Requirements

Before entering the US market, companies should assess whether their product labelling and information meet the applicable FDA requirements for the intended product category.

Key areas to review include:

• Pharmaceutical labelling: Review the proposed prescribing information and other required labelling elements submitted as part of the applicable drug application.¹ 
• Device labelling: Confirm that Medical Device labelling complies with applicable FDA requirements before the product is marketed in the United States. 
• Product information consistency: Check that the intended use, product claims, and information provided to users are consistent with the regulatory submission and applicable requirements. 
• Unique Device Identification: For applicable Medical Devices, assess whether Unique Device Identification requirements have been addressed as part of the product’s US regulatory compliance.² 

Identifying Regulatory Gaps and Compliance Risks

A FDA regulatory due diligence helps companies identify areas where existing regulatory preparation may not fully address applicable US market requirements.² 

The review should focus on these aspects given below before proceeding with US commercialisation:

• Identify applicable requirements: Review the product classification, regulatory pathway and requirements applicable to the specific product before US marketing. 
• Review evidence and documentation: Assess whether the information, testing and documentation needed for the applicable regulatory submission have been adequately prepared. 
• Identify compliance gaps: Determine whether additional testing, documentation or regulatory activities may be required based on the product’s characteristics and applicable FDA requirements. 
• Plan further regulatory actions: Use the identified gaps to determine the regulatory activities that need to be addressed before the company progresses towards US market entry.² 

Regulatory Due Diligence Checklist for US FDA Market Entry

Regulatory due diligence involves reviewing the key regulatory, quality, clinical and post-market requirements that may affect product approval and commercialisation in the United States. The table below summarises the main areas that should be assessed before US Food and Drug Administration market entry.

Table 1: Key Areas to Review During US FDA Regulatory Due Diligence

Conclusion

FDA regulatory due diligence is an important step before entering the United States market. It helps companies review regulatory requirements, identify compliance gaps and confirm that the necessary evidence and documentation are in place. 

• A well-planned due diligence process can reduce compliance risks, improve regulatory readiness and support successful US Food and Drug Administration submission, approval and long-term market compliance.
• CliniExperts Research provides US expansion compliance consultant services to support companies preparing for US market entry. 
• The company also assists with regulatory planning, documentation review and compliance assessments to support regulatory submissions and market readiness.

References 

1. Research C for DE and. How Drugs are Developed and Approved. FDA. May 12, 2026. Accessed August 10, 2026. https://www.fda.gov/drugs/development-approval-process-drugs/how-drugs-are-developed-and-approved

2. Health C for D and R. How to Study and Market Your Device. FDA. January 30, 2026. Accessed August 10, 2026. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device

3. Health C for D and R. Quality Management System Regulation (QMSR). FDA. February 2, 2026. Accessed August 10, 2026. https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr

4. Health C for D and R. Quality and Compliance (Medical Devices). FDA. January 30, 2026. Accessed August 10, 2026. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices

5. Affairs O of R. Registration and Listing. FDA. Published online May 19, 2026. Accessed August 10, 2026. https://www.fda.gov/industry/fda-basics-industry/registration-and-listing

6. Research C for DE and. Development & Approval Process | Drugs. FDA. August 25, 2025. Accessed August 10, 2026. https://www.fda.gov/drugs/development-approval-process-drugs

7. Health C for D and R. Device Registration and Listing. FDA. September 30, 2025. Accessed August 10, 2026. https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

8. Research C for DE and. Postmarketing Adverse Event Reporting Compliance Program. FDA. Published online January 20, 2026. Accessed August 10, 2026. https://www.fda.gov/drugs/surveillance-post-drug-approval-activities/postmarketing-adverse-event-reporting-compliance-program