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Combination Medical Devices, 21 CFR Part 11, the FDA & You

April 19, 2009

For some time now, statistics have shown a steady increase in the Food and Drug Administration's (FDAs) monitoring of pharmaceutical companies' compliance with 21 CFR Part 11 and other regulations.

This article in the New York Times makes reference to this, and the Federal Government's increasing focus (through the Government Accountability Office) on the safety of all pharmaceutical products (both equipment and medicines) on the market.

The article highlights a situation where the Federal Government is now insisting on retro-active compliance of medical devices that pre-date the enactment of medical device law in 1976. This kind of scrutiny from all regulatory bodies can be expected to increase over time.

The issue of Combination Devices is a particularly important one right now as the charter of a number of separate FDA departments have been combined to make sure that compliance regulations are properly maintained and monitored.