FDA Accelerates Automation
The FDA is set to make giant strides in regulation by 2026. Following digitisation, the next step is the automation of many services and functions.
We have summarised four changes made by the FDA in the first half of 2026 for you here.
These changes are relevant to anyone wishing to place products on the US market or to sell to countries that require FDA certification as part of their national certification process.
Introduction of the QMSR (Quality Management System Regulation)
Context
On February 2, 2026, the new “Quality Management System Regulation” (QMSR) came into effect. It replaces previous “Best Practices” regarding quality management (cGMP).
What's Changing?
The QMSR is the mandatory regulation governing quality management systems for medical device manufacturers in the USA. Whilst the old regulation contained a recommendation to align with ISO 13485, the new QMSR stipulates that QM systems must be ISO 13485-compliant. However, the QMSR contains further necessary requirements for QM systems – ISO 13485 is therefore not sufficient, but merely necessary.
The integration of ISO 13485 standardises the structure of the QMS more closely, whilst additional FDA-specific requirements remain in place.
Another important development in this context is the change to the QM audit protocol. Until February 2026, the FDA conducted its inspections using the so-called Quality System Inspection Technique (QSIT). This has now been replaced by inspection programme number 7382.850.
What is Important for Manufacturers?
Manufacturers should check whether their existing quality management system meets the requirements of ISO 13485 as well as any additional FDA requirements.
It is also advisable to review the older compliance programme and, where necessary, align your own QMS with the requirements of the protocol. ISO 13485 serves as the key reference point here, but should not be used as the sole basis.
Guidance and Collection of Examples on ‘Real-World Evidence’
The FDA works with a counterpart to the European concept of “clinical data”—namely, Real World Data (RWD), from which Real World Evidence (RWE) is derived.
The FDA had already redefined what exactly constitutes RWD or RWE in December 2025. This definition was further clarified in April 2026 and supported by a collection of examples.
These documents are intended to help FDA regulatory authorities and manufacturers clearly distinguish clinical evidence from modeled and nonclinical evidence.
What's Changing?
Basically, nothing. However, manufacturers and regulatory agencies now have reliable criteria for classifying various types of evidence as “real-world,” i.e., clinically relevant.
Conversely, this means that there may be lines of evidence that, in light of the new guidelines, can no longer be considered “real-world evidence.”
Optimization of the eSTAR Program
On October 1, 2025 , the FDA introduced a new online form for registering 510(k) and De Novo applications. Over the course of 2026, the eSTAR form was further optimized:
As of February 2, 2026, the eSTAR form for IVD and nIVD products was updated to comply with the revised QMSR regulations.
As of February 17, 2026, all eSTAR forms included the specific provisions for “real-world evidence” mentioned above.
Since May 1, 2026 , the eSTAR website has featured an FAQ section with frequently asked questions and answers.
U.S. Approval with the Support of BEO BERLIN
If you are considering seeking FDA approval for your products but find the complex regulations confusing, please do not hesitate to contact BEO BERLIN.
We have assisted many medical device manufacturers in obtaining market authorisation in Europe and North America.
Our experts have the experience and expertise needed to design and prepare marketing authorisation applications for the EU and U.S. markets.
Contact us – we look forward to hearing from you!!
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