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Compliance In Focus
Posted by John Lehmann on Thu, Mar 28, 2013

What’s Going on At OCP?

We ran across this article in MD+DI asking what is the Office of Combination Products (OCP)What’s Going on At OCP? doing?  For background, the OCP was set up at the urging of the medical device industry.  According to John Barlow Weiner, associate director, the mission of the agency is as follows:

The office uses an algorithm to determine which center should be primarily responsible for a product’s pathway.  It then coordinates with the various stakeholders to ensure the products are reviewed appropriately.

Initially OCP was given high marks for its ability to help industry members navigate the FDA and help bring combination products to market faster.  However, over time the office’s image has suffered.  There have been many complaints about the OCP:

  • Lacks the ability to accomplish goals due to  limited authority
  • The OCP has overstepped its bounds
  • Some charge the OCP is moving more products to CDER

Many feel that Center for Drug Evaluation and Research (CDER) is taking more leadership and control with the OCP.  This is of particular concern to the many companies that feel the regulatory pathway for drugs is more complex than 510(k)s. Werner suggests that more products are regulated by Center for Devices and Radiological Health (CDRH) than by CDER.    However, there are higher user fees at CDER than CDRH, which is a challenge to many product developers.

What started out as an industry pushed initiative might have caused some unwanted consequences of increased coordination between agencies.  The agency has pushed for reviewers to work together and apply consistent standards when assessing products.

What is your view of the Office of Combination Products?  Can you share any experiences you’ve had with the OCP?

Photo Credit: Darwin Bell

Regulations Revelations

Topics: OCP, Combination Products, Medical Device Industry


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