Food and Drug Administration

The US FDA has the mandate to protect and improve public health in the United States. To this end, the FDA regulates many products, including pharmaceuticals, medical devices, and IVDs. EU regulations and FDA requirements share many similarities, such as the use of an equivalent device as the basis for the approval of new products and the classification of products according to their risk class. Nevertheless, there are also significant differences between the two regulatory frameworks.

At the beginning of every project aiming for approval in the US, orientation is key – where does the technical specification and intended purpose of my product fit within the FDA, and which regulatory pathway applies to the product?

You can find a guide to this in our white paper “Understanding FDA Grouping of Medical Devices,” which is equally applicable to IVDs.

With over 3,300 products cleared each year via the 510(k) pathway, Premarket Notification is the most common approval route for medical devices and IVDs in Classes I and II. The central element of a 510(k) is the comparison to a product already on the US market (the so-called “predicate device”).

Although the 510(k) process is clearly defined, it also presents challenges depending on the product. Above all, the comparison to a predicate device is always a framework that you must fit into.

Together, we address:

• What requirements does the FDA set for products subject to 510(k) in the product code?
• Which predicate devices are suitable, and how can the comparison be made?
• Where is the comparison weak, and is a presubmission to the FDA advisable?
• What content belongs in the 510(k) submission?
• How can we respond to questions from the FDA review concerning the submission?

Another area of focus is the assessment of planned changes to products already cleared via 510(k). Here, we have developed a robust approach to provide sound arguments (and documentation!) as to whether a planned change to an existing product can be handled through internal documentation or whether the planned changes require a new 510(k).

The “De Novo Classification Request” (short: “De Novo”) offers the opportunity to bring novel products or products with new indications to the US market, for which a comparison to an existing predicate device within a 510(k) is not feasible. De Novo is only available for Class I and II products.

The focus of a De Novo submission is on risks that may arise from new functions, features, indications, or uses. These risks must be identified, investigated, and mitigated.

The De Novo pathway is less common than the 510(k). In 2023, 48 De Novos were granted.

Together, we address:

• How does the product differ from existing products, and what (new) risks arise from this?
• How can the safety and performance of the product be methodically investigated and demonstrated?
• For which aspects is a presubmission to the FDA advisable?
• What content belongs in the De Novo submission?
• How can we respond to questions from the FDA review concerning the submission?

Premarket Approval is the most comprehensive approval process for medical devices at the FDA and is used for products in the highest risk class, Class III. In 2023, only 35 new PMAs (excluding supplements to existing PMAs) were approved.

As part of a PMA, the safety and performance of the product must be demonstrated based on sufficient, valid, scientific data.

What this means for your product is highly individual. It is important to involve the FDA in the planning of data collection to ensure that the authority’s expectations are met.

Together, we address:

• By which methods (bench test, animal trial, clinical trial) can data on the safety and performance of the product be generated?
• When is the data “sufficient”?
• How can the FDA be involved in the planning?
• What content belongs in the De Novo submission?
• How can we respond to questions from the FDA review concerning the submission?