White Paper on Combo Products and FDA Regs Released by Microtest

A free white paper guides medical device manufacturers in the process of applying new FDA regulations to combination products embedded with pharmaceutical or biologic components. In the paper titled, "Combination Products 2.0: Applying the New FDA Regulations," Steven Richter, Ph.D., president and chief scientific officer of Microtest Laboratories, Inc., addresses the implications for manufacturers.

July 13, 2010

1 Min Read
White Paper on Combo Products and FDA Regs Released by Microtest

Some analysts estimate that combination products represent more than 30% of all new product submissions to FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of challenges for testing, sterilization, and contamination avoidance.

Over the past 12 months, FDA has developed streamlined regulations for good manufacturing compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010.

Once promulgated, manufacturers will be held accountable for compliance. In the white paper, Dr. Richter discusses:

* The new regulations.
* Determining principal mode of action -- device or drug?
* Stem cells and human tissue in combination products.
* The implications for testing and validation.
* An example: drug-eluting stents.

Download this free white paper from Microtest Laboratories.

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