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.

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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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