FDA's Medical Device Software Regulation Strategy 2025

Overview

The development and application of medical device software expands faster than can be managed by one federal agency. Although FDA relies on its own experience and expertise, input from other federal organizations, voluntary standards organizations and partnerships with industry has become a collaborative effort. At the same time, the device software industry needs to look beyond FDA itself to understand where FDA will eventually go in regulating software. The evolution of software has created unprecedented progress and unprecedented risks to the public. The management of the unprecedented risks requires the device industry to rely on more than just FDA’s guidance to comply with its regulato...ry expectations. FDA can expect developers to apply voluntary standards, such as ANSI, AAMI, IEC and ISO, all of which provide information on software verification and validation. The National Institute of Standards and Technology (NIST) has taken a leading role in publishing reports concerning the benefits and risks of third-party mobile applications. FDA has partnered with NIST in this effort. Likewise, NIST has published a report on cybersecurity management and wireless technology. FDA recently published a draft guidance to help the industry address software issues in premarket submissions. The guidance sets out a baseline from which to show the adequacy of the software, but it is not an endpoint for you. Are you prepared to integrate and apply new software risk management tools for your devices? Read more