Navigating the complex landscape of the US Food and Drug Administration (FDA) pre-market submissions can be a daunting task for medical device manufacturers. Understanding the different types of submissions, their specific requirements, and the submission process is crucial for a successful market entry.
The United States (US) represents one of the largest medical device markets in the world, offering significant opportunities to foreign manufacturers. However, medical device manufacturers seeking to access the US market need to navigate the complex Regulatory landscape of the US Food and Drug Administration (FDA). They must understand and comply with the US FDA’s regulations to successfully launch their products in the US.
The journey of bringing a medical device to the United States (US) market is a complex process governed by the US Food and Drug Administration (FDA). Manufacturers must understand the US FDA’s Regulatory pathway to ensure that their devices meet the necessary standards of safety and efficacy. This blog provides an overview of the US FDA’s Regulatory framework for medical devices, the types of submissions it covers, the timelines, and key considerations for navigating the agency’s approval process.
Software as a Medical Device (SaMD) is a burgeoning field that offers innovative solutions to enhance patient care and reduce healthcare costs. The International Medical Device Regulators Forum (IMDRF) describes SaMD as a software tool intended for use in one or more medical purposes, and which meet these purposes without being part of a hardware medical device. SaMD includes both medical devices as well as in-vitro medical devices. The USFDA has implemented SaMD regulations to ensure that the devices meet the same safety and efficacy standards as traditional medical devices.
As we all know, the FDA will first evaluate the potential risk of a medical device before it is launched in the USA. The evaluation is done through a risk-based classification process to ensure the device’s safety, quality, and efficacy. The low-risk Class I devices require only general controls, and the high-risk Class II devices are subject to special controls and require more Regulatory scrutiny and oversight. But, for the highest-risk Class III devices, the FDA uses the most stringent Regulatory control – the Premarket Approval Process.
In December 2018, the United States Food and Drug Administration (US FDA) published the final guidance on Manufacturing Site Change Supplements: Content and Submission. Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.
Registering a medical device with the FDA requires an apt submission pathway. In most of the cases, identifying and selecting a pathway is quite simple. For example, as discussed in our previous blog, if there exists a predicate for your medical device, then file a 510(k). If not or if your device is of class III, then file a pre-market approval (PMA). But is it always the case? Not necessarily.
