U.S. Bill to Modernize FDA Device Inspections

A bill was introduced in the U.S senate to to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. A bill is essentialy a draft law and may or may not become law and may or may not be significantly modifed in the process of approval. The full bill is at the link provided.

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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