FDA CBER 1994 BECS Manufacturer Letter

This letter was issued at the point FDA ramped up regulation of Blood Establishment Computer Systems as medical devices. It informs manufacturers of such system that they need to comply with all medical device manufacturer regulations and provide premarket submissions for 510(k) clearance of such devices. The letter defines the types of functionality that would be considered as a medical device.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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