Although it is one of the most notoriously complex bureaucracies in the world, the FDA has been moving toward higher medical device approval rates. In 2015, it reached a 15-year high of 98% approval for high-risk devices – increasing nearly 30% from 2012.
This is a significant departure from 2010’s 59% approval rate.
Recent trends seem to favor innovation, but it is important not to underestimate the significant investment of time, effort, and expertise needed to achieve FDA approval.
Understanding FDA Classification and the Approval Process
Simple medical devices similar to predicate devices – existing, approved products – have the easiest time in the FDA approval pipeline. These are referred to as Class I devices and represent the lowest risk category assessed by the FDA.
In some cases, Class I devices secure approval in as little as one month.
It is possible, but rare, for devices to receive Class I status without predicates. In most cases, however, they will be assigned to Class II. Truly groundbreaking medical devices typically receive the most onerous designation, Class III.
It’s far from unusual for Class III devices to take many years for approval.
Each successive Class carries with it greater complexity and overall cost. Although most steps are broadly similar, Class III devices require additional forms, clinical research, and inspections.
What to Expect from Class III Device Approval
All medical device companies must begin by establishing a Quality Management System (QMS) that meets guidelines set forth in Code of Federal Regulations Title 21 Part 820 – usually called FDA Good Manufacturing Processes. Internationally-recognized standards like ISO 13485 can help in this process, which must be complete before a device will receive its final approval.
Most Class II and all Class III devices require clinical studies. The enterprise should seek pre-submission guidance from the FDA before beginning research. “Pre-Sub” is a free program that allows you to save time and resources by setting up a customized consultation with FDA experts.
An Investigational Device Exemption (IDE) is necessary for all devices requiring clinical studies. In addition, a detailed clinical trial protocol must be developed. This is an extremely complex process which may, on its own, represent the bulk of the time devoted to approval.
Once significant research has been undertaken, the enterprise may submit a Premarket Approval (PMA). The information submitted to the FDA must furnish “sufficient valid scientific evidence” to make certain that the device is both safe and effective for its intended uses.
Although regulations provide 180 days for a PMA review, it does typically take longer. The standard fee for a PMA submission is $310,764, though approved small businesses may pay an alternate fee of just $77,691. These fees are subject to change and are based on submission date.
Upon PMA approval, device manufacturers are subject to a complete facility inspection of all major suppliers involved in design and production of the approved device. All parties must meet the obligations set forth in FDA’s Quality System Regulations (QSR).
Upon successful completion of the inspection process, the FDA posts the PMA approval letter online. The FDA’s official notice on their website is considered authorization to commence commercialization activities. Approval does not generally expire as long as significant changes are not made to the product.
This is only a capsule summary of an extraordinarily rigorous process. FDA approval demands that the enterprise be prepared for unprecedented scrutiny on many levels.
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