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.
Navigating the complex landscape of medical device regulations can be a daunting task for manufacturers and healthcare professionals. The United States Food and Drug Administration (US FDA) classifies medical devices into different categories, based on risk, intended use, and other factors. Understanding these classifications is crucial for ensuring compliance as well as the safety and efficacy of medical devices.
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.
The US FDA has published a guidance document that will help the industry and the Health Agency (HA) staff determine when a software change to a medical device requires a manufacturer to submit and obtain the FDA clearance of a new premarket notification (510(k)). This guidance intends to enhance the predictability, consistency, and transparency of the “when to submit” decision-making process by providing a least burdensome approach and describing the Regulatory framework, policies and practices underlying such a decision, specifically related to software changes.
To ensure the safety and efficacy of medical devices entering the US market, the US FDA requires every manufacturer to submit a mandatory 510(k) pre-market notification. It is mainly applicable for Class II devices and a few Class I and Class III devices and is based on the principle of substantial equivalence. According to this principle, the new device should demonstrate substantial equivalence of safety and efficacy with a predicate device, which is legally marketed in the US.
The FDA has introduced “Safer Technologies Program for Medical Devices (STeP)” in line with the “Breakthrough Devices Program”, to facilitate timely access to certain devices and device-led combination products. The existing program is voluntary and applicable for devices aimed to treat and diagnose non-life threatening or reasonably reversible disease conditions, whereas, the Breakthrough Devices Program is intended for devices to be used in life-threatening or irreversibly debilitating disease conditions.
The US FDA continues to release and update the guidelines and enforcement policies for efficient management of the device Regulatory affairs in the USA, alongside handling the emergency health situation that surfaced due to the COVID-19 pandemic.
