RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 6 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > Quality & Compliance I: Combination Product Quality Systems

Quality & Compliance I: Combination Product Quality Systems

Posted 01 December 2009 | By

This article, the fifth in a series on the regulation of combination products in the US, considers the state of the quality system regulatory framework for combination products. This article is not a commentary on the recently published proposed rule1 or the previously published draft guidance2 on quality systems for combination products. Rather, it describes approaches based on existing regulations that may be taken now to establish a compliant quality system for the manufacture of a combination product in anticipation of the final rule.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.