How CLSI standards help international manufacturers navigate FDA regulatory approval with confidence

For manufacturers, medical device companies, and laboratories that use the commercial diagnostic tests they produce, obtaining clearance or approval from the United States Food and Drug Administration (FDA) is a significant milestone. However, the process can be lengthy and daunting, with review and approval timelines often spanning years. For international businesses looking to enter the US market, the obstacles can be particularly challenging. Submissions must be meticulously detailed to avoid additional studies, product revalidation, and additional FDA inquiry.

With hundreds of manufacturers worldwide seeking a greenlight from the FDA, a common hurdle for international manufacturers is the disparate regulatory landscapes across the US, European Union, and Asian countries. These regulatory differences may require companies to revalidate their devices and adopt practices not required in their home regions, thereby slowing down the submission process and impeding medical progress.

These challenges can ultimately delay access to innovative diagnostics and life-saving technologies for patients and health care providers. Every setback in regulatory clearance or approval represents time lost in delivering better care.

The path to clearance

Companies are not left without choices when going to the FDA for clearance or approval to market their product. The FDA offers several pathways depending on the classification of the device:

• 510(k) Premarket Notification – The most common pathway is a 510(k) premarket submission to the FDA to demonstrate that a device is safe and effective, and that it is substantially equivalent to a device already on the market. This pathway is used for most Class II devices (moderate risk).
• De Novo Classification Request – This pathway is for new devices that are not high-risk but cannot be compared to another cleared or approved device on the market. A De Novo submission requests classification into Class I (low risk) or II. Once the De Novo device is classified and enters the market, other manufacturers can use it as a predicate device in a 510(k) Premarket Notification and claim substantial equivalence.
• Premarket Approval (PMA) –This pathway is for Class III (high-risk) devices that are used to sustain human life, such as pacemakers, stents, heart valves, etc. These devices require rigorous clinical studies, extensive clinical data, FDA preapproval inspections, and research from peer-reviewed publications that show the device is safe and effective. Premarket approval can take years, and a PMA is the most expensive pathway.

Although the premarket pathway to FDA clearance or approval is defined, it is also complex. Companies that obtain FDA approval or clearance can get their life-saving products on the market in the US. But before that can occur, FDA reviewers need proof that every device being proposed is safe and effective. Generating that proof can entail extensive data submissions, clinical trials, and millions in costs. Although a 510(k) submission provides a generally faster way to get devices on the market, not all classifications meet the necessary criteria for this type of submission, making the path complex for some and easier for others. With a De Novo submission, companies do not have a predicate device to compare their device to and are producing first-of-a-kind devices that will set the mark for future, similar devices.

For high-risk Class III devices, the Premarket Approval (PMA) process represents the biggest regulatory hurdle some companies may face. These devices are subject to the FDA’s highest level of scrutiny and often require extensive clinical trial data, nonclinical studies, and manufacturing documentation, which adds more cost, time, and complexity to the path toward approval.

“All of these efforts are directed towards an overarching goal to drive the development of high-quality standards that are fit for regulatory use,” says Terry Woods, Ph.D., the FDA’s Director of the Division of Standards and Conformity Assessment.

Using CLSI standards to expedite regulatory approval

With 132 formally recognized standards (105 complete, 27 partial) in the FDA’s Recognized Consensus Standards Database, CLSI offers a way for domestic and international companies to validate their devices with confidence and ensure a quality medical product is entering the US market. This recognition signifies that CLSI’s thorough document development process and expert consensus have produced quality guidelines that can be used by device manufacturers to meet FDA compliance for safety, efficacy, and reliability.

“We recognize over 1,400 standards. Over 100 of them are from CLSI. That’s 10% of our recognized standards. You can see how important CLSI is to our program,” Dr. Woods shares.

Organizations that use CLSI standards can trust that they’re implementing best practices that are vetted by subject matter experts and regulatory authorities. This creates a level of trust that is essential in health care where patient safety and care are at the forefront. FDA representatives currently serving on CLSI Document Development Committees (DDCs) bring CLSI documents to the FDA Standards Management Staff (SMS) who work to identify and evaluate standards for recognition.

“Congress has directed the FDA to take the least burdensome approach to medical device pre-market evaluation,” says CLSI CEO Dr. Barbara Jones “When a standard is recognized, people who have followed that standard can point to it to be able to use it.”

Submitting a declaration of conformity

Because of time and cost, manufacturers can often accelerate clearance or approval by submitting a Declaration of Conformity (DoC). A DoC allows a company to demonstrate compliance by referencing FDA-recognized consensus standards that are developed by qualified Standards Development Organizations (SDOs) such as CLSI.

“A well written standard with clear test methods and acceptance criteria makes conformity assessment more straightforward for both manufacturers and regulators,” explains Dr. Woods.

Using recognized international consensus standards and a DoC has multiple benefits. It can increase predictability, streamline the FDA’s premarket review process, and provide clearer regulatory expectations. Moreover, when used appropriately, these standards typically reduce the documentation burden and may shorten review times.

“A DoC to a recognized standard typically will not require a complete test report unless otherwise directed by FDA guidance,” says Dr. Woods. “Some complete test reports can be hundreds of pages long and they often raise questions that require time and resources to answer.”

To successfully pursue a DoC, manufacturers should identify the appropriate recognized standards early in the design and validation process, ensure that testing aligns with those standards, and document all supporting evidence for FDA submission. This approach streamlines communication with the agency and helps reduce the need for additional data requests or testing.

“At its core, the DoC is a communication to the FDA. We always welcome communication. The more we can communicate, the better,” Dr. Woods shares. “It’s key to the use of a recognized standard. A DoC is a very simple and straightforward document.”

CLSI’s FDA Approval Webinar | Streamline the FDA Approval Journey: A Panel Discussion with the FDA, CLSI, and Abbott Laboratories, provides practical guidance and examples of how to use a DoC effectively within a quality system.

Conclusion

At its core, every FDA pathway is about more than compliance. It’s also about bringing innovation to patients safely and efficiently. When standards are recognized and applied, the process not only accelerates, but also strengthens confidence in the quality of care delivered. This is the role CLSI continues to play by helping transform regulatory hurdles into opportunities for better health outcomes worldwide.

CLSI consensus standards transcend specific regulatory frameworks. They establish international best-practice guidance that helps manufacturers and laboratories show quality, accuracy, and reliability in any setting, supporting success whether a product is being evaluated by the FDA, another global authority, or internal quality systems. By advancing global evidence-based standards, CLSI equips manufacturers and laboratories to achieve excellence and deliver safe, more reliable results for patients everywhere.

“We are all here working for the patients to make sure they have the medical devices they need, when they need them,” Dr. Woods concludes.

Need a document to reference?

With 100+ CLSI documents in the FDA’s Recognized Consensus Standards Database, your organization can streamline the premarket process and receive the greenlight you need to get your device on the market faster.

Explore how CLSI standards align with FDA requirements in our FDA Accreditation Crosswalk.You can also refer to the FDA’s website for more information.