The FDA has reissued draft guidance for premarket cybersecurity considerations four years after the previous draft guidance, and eight years after the issuance of the most recent final guidance. While this draft guidance is not the final word on this policy, we would advise our clients that it represents a fundamental shift in the agency’s approach to cybersecurity, one that comes with a substantially more demanding set of requirements in the premarket phase of device development.
The FDA’s new draft guidance for the use of digital health technologies (DHTs) for remote data acquisition in clinical trials promises to help advance the market for a wide range of products in the digital health space. However, developers of these products should be aware that their products will be subject to a substantial amount of verification and validation work, along with a considerable load of usability studies.
The FDA’s approach to validation of computer systems used in device manufacturing IT systems hasn’t drawn the attention that software as a medical device has, but that doesn’t mean this requirement hasn't wanted for controversy.
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
