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CDRH Regulatory Reliance Portal for Medical Devices

The medical device sector has become increasingly globalized and complex with regard to the design, development, manufacturing, and distribution of products. Technologies are evolving at a rapid pace. Each economy may develop and implement its own regulatory paradigm and pathways to market based on the applicable statutory requirements, especially as emerging technologies are considered. 

Resources may not be optimally used when regulatory authorities must administer, and industry must navigate, numerous and sometimes redundant regulatory requirements. Reducing inefficiencies through harmonization, convergence, and reliance can help to streamline the regulatory path to market and accelerate patient access to safe, effective, and high-quality medical devices in the United States and globally.

This portal can serve as a resource for regulatory authorities (RAs), including those embarking on their first reliance program, those aiming to enhance their existing program or create additional reliance frameworks, and those needing additional information under existing frameworks. Additional information on existing reliance frameworks can be found in IMDRF/GRRP WG/N89 FINAL: 2026 Playbook for Medical Device Regulatory Reliance Programs. For regulators considering regulatory reliance based on CDRH decisions, or seeking to better understand CDRH regulatory and decision-making processes, please contact CDRHInternational@fda.hhs.gov.

Introduction to Reliance

What is regulatory reliance?1

  • Regulatory Reliance refers to an act whereby the regulatory authority in one jurisdiction may take into account and give significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information in reaching its own decision. The relying authority remains independent, responsible, and accountable regarding the decisions taken, even when it relies on the decisions and information of others.

    As noted in the IMDRF Reliance Playbook, reliance does not represent a less stringent form of regulatory oversight or outsourcing of regulatory mandates, nor does it compromise independence. Instead, reliance is a form of regulatory oversight that, when based on constructive regional and international collaboration, can facilitate and promote convergence and the use of common international standards and guidelines, resulting in more predictable, faster approval to improve access to quality-assured medical products for patients worldwide.

What is the difference between regulatory harmonization, convergence, and reliance?

  • Regulatory Harmonization refers to the process whereby technical guidelines are developed to be uniform across participating regulatory authorities in multiple countries.
  • Regulatory Convergence refers to a voluntary process whereby the regulatory requirements in different countries or regions become more similar or “aligned” over time. The process results from the gradual adoption of internationally recognized technical guideline documents, standards and scientific principles, common or similar practices and procedures, or the establishment of appropriate domestic regulatory mechanisms that align with shared principles to achieve a common public health goal. 

Why might a regulatory authority consider incorporating regulatory reliance?

  • Saves resources and time (so that resources can be allocated to areas of greatest public health impact)
  • Improves efficiency and expedites access to medical products while maintaining sovereignty over decision-making
  • Allows regulatory authorities to focus resources on high-priority areas
  • Promotes supply chain resilience
  • Enhances and strengthens regulatory capacity, particularly with innovative or novel products
  • Reduces duplication and costs to industry
  • Provides flexibility to adapt to needs of the regulatory system

Why would a regulatory authority NOT consider incorporating reliance? What are its limitations?

  • Fundamental differences in regulatory pathways (e.g., device classification)
  • Laws that do not allow for reliance in decision-making

Reliance in Practice/Establishing Reliance-Based Pathways

In general, what is needed to establish a reliance-based regulatory pathway?

  • Considerations for establishing a reliance-based pathway include establishing the legal and policy basis for reliance, building confidence and trust on the outputs of reference regulatory authorities, tailoring reliance strategies to the needs of national health and regulatory systems, identifying resources for implementation, addressing “sameness” of products across jurisdictions, and engaging interested stakeholders.

What are the ways a regulatory authority can rely on the FDA’s clearance, approvals, and other regulatory decisions?

  • Regulators may flexibly tailor a reliance strategy to address their national health and regulatory needs, which can take different forms depending on whether it is pre- or post-market. For example, a regulator could leverage the reviews of trusted regulators to conduct an abridged evaluation and offer an expedited pathway to market. Alternatively, another regulator might choose to leverage reliance only for devices of certain risk levels or in special circumstances, such as a public health emergency. In a post-market setting, a regulator could use reliance for surveillance and assessments of manufacturers’ quality systems. 

Establishing the FDA as a Comparable Regulator

Where can I learn more about the FDA’s medical device regulatory framework?

The following resources are available on the FDA’s website and provide an overview of FDA medical device regulation and classification. Additional resources are discussed in the various sections below.

A full list of English and Spanish training modules is available online at CDRH Learn.

What information and evidence does the FDA consider for authorization?

PMA is the most rigorous type of device marketing submission, where the review standard relies on an independent demonstration of safety and effectiveness of the device. PMA is required for high-risk devices where general and special controls alone are not sufficient to provide reasonable assurance of safety and effectiveness of the device and the device is life-supporting or life-sustaining, is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. For details, see the Regulatory Controls page.

However, the PMA pathway is not used for all medical devices. Certain, lower-risk devices similar to other devices on the market may be eligible for the 510(k) pathway, or low- to medium- risk devices without a predicate device already on the market may be eligible for De Novo classification. Both pathways provide appropriate patient safeguards (e.g., general controls, special controls) for the level of risk of the device. Subjecting devices to higher regulatory oversight than deemed necessary could result in unnecessary costs and delays in getting patients access to the devices they need, while diverting the FDA's staff and resources away from evaluating high-risk or novel devices.

The FDA carefully balances the need to provide patients with rapid access to medical devices while providing reasonable assurance of safety and effectiveness for those medical devices through the FDA's review. The agency applies a least burdensome approach to the premarket review process of devices based on the device's classification and degree of risk that the device presents, relying on a comprehensive review of robust safety and performance data and the total product life cycle approach. Regardless of the regulatory pathway for the device, CDRH’s premarket review involves a team-based approach that includes relevant non-clinical and clinical expertise and considers the proposed intended use and use environment for the device as part of the review.

As further described in the FDA guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], the 510(k) review standard is comparative to a predicate device. Nonetheless, safety and effectiveness underlie the substantial equivalence determination in every 510(k) review. The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device). Because there are many types of devices, the content in 510(k) submissions can vary greatly. Additional considerations on the strengthening and modernization of the 510(k) program are outlined on the CDRH website.

What public information does the FDA make available that regulatory authorities can use to support reliance?

The FDA provides publicly available information on regulatory decisions and actions in the FDA Medical Device Databases. How this information can be used is described in the scenarios outlined below. 

How can a regulatory authority considering a product verify it is the same product as assessed by the FDA?

  • A regulatory authority can utilize the FDA databases specific to medical devices and other supporting documentation submitted by applicant to verify that the product under consideration is the same as the one assessed by the FDA.
    Here is how:
    1. Access the relevant FDA Database (refer to the list of databases depending on device type) and search for the product using key identifiers (i.e. submission number, product name, etc.). 
    2. The search results can be used to verify the product’s information:
      • Confirm the name of manufacturer or applicant and address listed in the FDA database
      • Product Description: Cross-check the product description, including indications for use, device features, and intended use with the regulatory submission
      • Device Model or Trade Name: Verify the model and brand match the product you are reviewing
  • Review the FDA submission summaries and verify these match the specifications of the product being reviewed:
    • 510(k) Summary: Includes device description, indications for use, technological characteristics, and predicate device details
    • PMA Summary: Contains clinical and non-clinical data, device functionality, and approval conditions
    • De Novo Order: Describes the device risk assessment and special controls for its classification
  • Confirm technical specifications.
    • Cross-check technical details such as design and materials, device dimensions and performance characteristics, and software details (if applicable)
  • Check that indications for use (as described in the approval/clearance documents and/or as described in the labeling) are identical: 
  • Request to the manufacturers (if needed), documentation confirming FDA clearance or approval such as Clearance/approval letter from the FDA, and/or copy of the submission summary.

How can a regulatory authority verify the product they receive was manufactured in sites inspected by the FDA?

The FDA Inspection Classification Database provides information on the manufacturing facilities inspected by the FDA for compliance with regulatory quality standards.

Steps: 

  1. Access the Inspections Database.
  2. Search for the Manufacturer: Enter the facility name, address, or FEI (Facility Establishment Identifier) number, be sure to filter by inspection type (e.g. medical devices).
  3. Inspection details can be reviewed to verify that the facility has been inspected for compliance with FDA regulations, typically this means inspections classified by the FDA to be No Action Indicated (NAI) or Voluntary Action Indicated (VAI). The FDA inspects manufacturing facilities to assess their overall compliance with the quality standards and requirements, focusing on the systems and processes in place rather than inspecting individual products made at those facilities.

Another way to verify if a manufacturing facility complies with FDA regulations is by reviewing a Certificate to Foreign Government (CFG), if available from the manufacturer.

Steps:

  1. Verify the product name, and name and address of manufacturing facility are listed on the CFG, and check that the CFG certificates include a statement of FDA compliance.
  2. Use the CDRH Export Certificate Validation (CECV) database to validate the authenticity. Results displayed in this database include the facility name, certificate type, expiration date, certificate number, and the number of pages per certificate.

How would a regulatory authority using the FDA as a comparable regulator learn about medical device safety issues and recalls?

The FDA regulates safety and effectiveness throughout the total product life cycle of a medical device – from the device's premarket review to assure the safety of devices entering the market, to the continued surveillance of medical devices to monitor for adverse events and recalls. An open recall does not necessarily imply a device safety issue. 

Search the MAUDE or Recall databases to find information regarding adverse events or recalls regarding the product. CDRH regularly monitors these to determine if existing risk mitigations are sufficient. 

If, after using these resources, questions remain regarding the identity of the product submitted under a reliance framework, please contact CDRHInternational@fda.hhs.gov.

For additional resources on reliance programs, refer to the IMDRF Reliance Playbook, or contact CDRHInternational@fda.hhs.gov. 

1These are the descriptions from CDRH’s International Harmonization Draft Strategic Plan 2023, which are consistent with IMDRF/GRRP WG/N89 FINAL: 2026 Playbook for Medical Device Regulatory Reliance Programs.

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