CDRH has launched a reference portal explaining regulatory reliance programs for assessments and decisions by other regulatory authorities, focusing on using FDA data without transferring decision-making responsibility or reducing safety requirements. The portal provides guidance on verifying the identity of devices and their manufacturing sites and monitoring post-market safety.
The U.S. Food and Drug Administration, through the Center for Devices and Radiological Health (CDRH), published a regulatory portal dedicated to regulatory reliance programs in the medical device field. The portal targets regulatory authorities considering establishing a reliance program for the first time, developing an existing program, or understanding frameworks based on CDRH decisions and assessments.
The source starts from the reality that the design, development, manufacture, and distribution of medical devices have become increasingly cross-border and complex, alongside the rapid advancement of emerging technologies. FDA believes that duplicating regulatory requirements across markets may waste the resources of regulatory authorities and companies, while coordination, convergence, and reliance on trusted assessments can shorten the path to market and improve patients’ access to safe and effective devices.
Reliance Does Not Mean Delegating the Decision
The portal defines regulatory reliance as a regulatory authority in one country taking the assessment results of another authority or trusted institution and giving them significant weight when making its decision. However, the relying authority remains independent and legally responsible for its decisions, even when it uses information or decisions issued by another authority.
CDRH emphasizes that reliance is not a less rigorous form of oversight, outsourcing of legal responsibilities, or a relinquishment of independence. The portal also distinguishes between reliance, regulatory convergence—which makes requirements more similar over time—and regulatory harmonization, which aims to unify technical guidance among participating authorities.
What Can Regulatory Authorities Gain?
- Saving time and resources and directing them to areas with the greatest public-health impact.
- Accelerating device availability while preserving the local authority’s sovereignty in decision-making.
- Reducing duplicated work and costs for companies.
- Strengthening regulatory capacity, particularly when dealing with innovative or new products.
- Supporting supply-chain resilience.
However, the portal identifies clear limitations, including differences in device classifications and licensing pathways among countries, or the existence of laws that do not permit reliance in decision-making. FDA therefore does not provide a single mandatory model; one authority may use an abridged review based on the assessment of a trusted authority, while another may limit reliance to devices with specified risk levels or to public-health emergency situations. This may also extend to the post-market period, such as device monitoring and assessment of manufacturers’ quality systems.
How Does an Authority Verify the Device and Its Manufacturing Site?
The portal stresses the need to prove that the product being presented is the same product assessed by FDA. This includes matching the company name and address, the device description, indications for use, and technical characteristics, as well as the model or trade name, followed by reviewing the documents appropriate to the licensing pathway. These documents include 510(k) summaries, PMA summaries, and De Novo orders, in addition to clearance or approval letters when needed.
FDA databases provide information that can be used for this purpose, including the PMA, 510(k), and De Novo databases, facility and device registration lists, the AccessGUDID database, and the facility inspection database. The regulatory authority can search for the manufacturer, its address, or the Facility Establishment Identifier (FEI) number, and review the inspection classification, with the reminder that an inspection assesses the facility’s quality systems and processes and does not examine every individual device.
CDRH also points to certificates for export to foreign governments and the Certificate Export Verification Clearance (CECV) database to verify the authenticity of the certificate, facility details, certificate type, and expiration date.
Monitoring Does Not End When the Device Enters the Market
FDA’s model is based on the device’s entire life cycle. Therefore, the proposed references include databases for recalls, corrections, and removals; adverse event reports in MAUDE; and post-market study requirements. The portal explains that the existence of an open recall does not necessarily mean that a safety problem exists, making the interpretation of post-market data as important as locating it.
Why Does This News Matter?
The portal’s practical value is that it turns the concept of regulatory reliance from a general principle into an actionable checklist: a legal basis, confidence in the reference authority, product matching, verification of the manufacturing site, and post-market monitoring. The remaining open questions concern each country’s ability to align these steps with its laws and device classifications, and the extent to which an FDA decision can be used without local differences in risks or uses becoming a cause of an inappropriate decision.