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The End of Validation as We Know It

A deep-dive into the FDA's new draft guidance for Computer Software Assurance for Manufacturing, Operations, and Quality System Software.


Since its inception, the Center for Devices and Radiologic Health (CDRH) has operated with the vision of providing patients with “access to high-quality, safe, and effective medical devices of public health importance first in the world.”

A department of the U.S. Food and Drug Administration (FDA), CDRH promotes quality medical devices and radiation-emitting products through facilitating innovation throughout the United States by advancing regulatory science, providing industry with consistent and transparent pathways for treatment and use, and assuring consumer confidence in marketing devices. Basically, CDRH authors the pathways to approval that manufacturers must follow during Step 3 of the five-step medical device development process, prior to FDA review.

To help steady the device industry’s regulatory plod when it comes to manufacturing software, later this year the FDA is issuing Draft Guidance or Computer Software Assurance for Manufacturing, Operations, and Quality System Software.

When compared to the pharmaceutical and biotech industry, it’s oft-noted that medical device manufacturers are behind their counterparts when it comes to software validation. The reason for the lag, it’s suspected, lies in the differentiation between the devices’ native software as opposed to the software used to manufacture the devices.

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