FDA Launches CDRH Regulatory Reliance Portal for Medical Devices
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health, CDRH, has developed a Regulatory Reliance Portal for Medical Devices.
The portal is intended to support regulatory authorities seeking to establish, strengthen or better understand regulatory reliance frameworks involving FDA medical device decisions and information.
Why Regulatory Reliance Matters
The FDA notes that the medical device sector has become increasingly globalised and complex across design, development, manufacturing and distribution.
At the same time, regulatory systems may impose different or overlapping requirements, which can create inefficiencies for both regulators and industry. The portal highlights harmonisation, convergence and reliance as mechanisms that can streamline pathways to market and support faster patient access to safe, effective and high-quality medical devices.
What Is Regulatory Reliance?
The portal defines regulatory reliance as an approach where one regulatory authority takes into account and gives significant weight to assessments performed by another regulatory authority, trusted institution or other authoritative source.
Importantly, the relying authority remains independent, responsible and accountable for its own regulatory decision.
The FDA also stresses that reliance is not a less stringent form of regulatory oversight and does not mean outsourcing regulatory responsibility. Rather, it can support convergence, international collaboration and more predictable regulatory pathways.
Harmonisation, Convergence and Reliance
The portal distinguishes three related concepts.
Regulatory harmonisation refers to development of uniform technical guidelines across participating regulatory authorities.
Regulatory convergence refers to the gradual alignment of regulatory requirements through adoption of international standards, scientific principles, guidance and common practices.
Regulatory reliance allows an authority to use assessments or decisions from another trusted authority while retaining responsibility for its own decision-making.
Potential Benefits of Reliance
The FDA identifies several potential benefits for regulatory authorities.
These include:
saving regulatory resources and time;
improving efficiency;
accelerating access to medical products;
preserving sovereignty over regulatory decisions;
allowing regulators to focus on higher-priority areas;
strengthening supply chain resilience;
building regulatory capacity;
reducing duplication and costs for industry;
increasing flexibility in regulatory systems.
The portal also recognises limitations, such as differences in regulatory pathways, including device classification systems, and laws that may prevent reliance-based decision-making.
Establishing Reliance-Based Pathways
The FDA outlines several considerations for authorities developing reliance pathways.
These include establishing an appropriate legal and policy basis, building trust in reference regulators, tailoring reliance strategies to national needs, identifying implementation resources, assessing whether products are the same across jurisdictions and engaging relevant stakeholders.
A regulatory authority may, for example, use a trusted regulator’s review to conduct an abridged assessment, offer an expedited route to market or limit reliance to particular risk classes or exceptional situations such as public health emergencies.
Reliance can also be used post-market, including for surveillance and assessment of manufacturers’ quality systems.
FDA Regulatory Pathways
The portal provides information on major FDA medical device pathways that other regulators may consider when using FDA decisions as part of a reliance framework.
These include:
Premarket Approval (PMA) for high-risk devices;
510(k) for certain lower-risk devices that demonstrate substantial equivalence to a predicate;
De Novo classification for certain low- to moderate-risk devices without a legally marketed predicate.
The FDA explains that its premarket review approach balances timely patient access with reasonable assurance of safety and effectiveness and applies a least-burdensome, risk-based approach depending on device classification.
Public FDA Information Available for Reliance
The portal highlights several publicly available FDA resources that regulatory authorities can use to support reliance decisions.
These include databases for:
Premarket Approvals;
510(k) clearances;
De Novo decisions;
FDA inspections;
export certifications;
AccessGUDID;
establishment registration and device listing.
These resources can help regulators verify device authorisation status, product identity, manufacturing information and other relevant regulatory details.
Verifying Product Sameness
The portal provides practical steps for determining whether a device presented under a reliance framework is the same as the device assessed by FDA.
Regulators may compare:
manufacturer or applicant name and address;
product description;
indications for use;
intended use;
model or trade name;
technological characteristics;
technical specifications;
materials and design;
performance characteristics;
software details, where applicable.
The portal also recommends reviewing relevant 510(k), PMA or De Novo summaries and requesting FDA clearance or approval documentation from manufacturers where necessary.
Manufacturing Site Verification
The FDA also explains how regulators can determine whether a manufacturing site has been inspected.
The FDA Inspection Classification Database can be searched using information such as facility name, address or FEI number. Inspection classifications such as No Action Indicated (NAI) and Voluntary Action Indicated (VAI) may provide relevant information about compliance status.
A Certificate to Foreign Government, where available, can also help confirm product and manufacturing site information, with authenticity checked through the CDRH Export Certificate Validation database.
Post-Market Safety and Recalls
The portal also provides resources for regulatory authorities seeking information about medical device safety issues and recalls.
These include FDA post-market monitoring resources, recall information, post-market studies and the MAUDE database for adverse event information.
The FDA notes that it regulates medical device safety and effectiveness throughout the total product life cycle, from premarket review through continued post-market surveillance.
Link to the IMDRF Reliance Playbook
The portal also refers regulatory authorities to the IMDRF/GRRP WG/N89 FINAL: 2026 Playbook for Medical Device Regulatory Reliance Programs.
This resource provides broader guidance for authorities designing and implementing regulatory reliance programmes.
Impact on Regulators and Medical Device Manufacturers
For regulatory authorities, medical device manufacturers and international regulatory teams, the CDRH portal provides a practical framework for understanding how FDA information may support reliance-based decision-making.
Stakeholders should pay particular attention to:
the distinction between reliance, harmonisation and convergence;
use of FDA decisions in abridged or expedited pathways;
PMA, 510(k) and De Novo information;
public FDA databases;
device sameness verification;
manufacturing site inspection information;
export certificates;
post-market surveillance and recalls;
legal and policy requirements for reliance;
international regulatory cooperation.
For companies operating across multiple jurisdictions, the portal is also relevant because greater use of regulatory reliance could reduce duplication, support more predictable market access and increase the value of high-quality regulatory documentation prepared for major reference authorities.
