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Compliance In Focus
Posted by John Lehmann on Wed, Feb 29, 2012

Should the FDA Modify the De Novo Process?

Senators Robert Casey and John McCain have introduced a bill to Congress titled the “Safe, Efficient, and Transparent Medical Device Approval Act” or ‘SET Device Act’. The goal of this bipartisan bill is to streamline the regulatory approval process for investigational devices by trimming down some regulations which the senators believe support innovation.

The act calls for Congress to amend the Federal Food, Drug, and Cosmetic (FD&C) Act with respect to medical device regulation, specifically in respect to the de novo process. The senators hope Congress will agree that the process should be changed so that new products can be evaluated directly without needing to determine whether there are similar devices on the market.

Under the current process companies must:

  • First, Submit a 510(k), even if no known predicate device exists
  • Then, the FDA will confirm there is no predicate device, and the product will receive a ‘Not Substantially Equivalent’ determination

As noted in the bill, the Institute of Medicine (IOM) released a report in July of 2011 which revealed “between 2005 and 2009, review times for novel therapeutic devices through the de novo process nearly tripled. The report concluded that the current de novo process has not met its potential as an alternative regulatory pathway, and recommended the establishment of a modified de novo process.”

In a news-release, Senator John McCain explained that “With the U.S. medical device industry struggling to maintain international leadership, this legislation streamlines the outdated regulatory approval process to improve patients’ access to safe and effective medical devices.” Overall, both senators are noted to agree that an updated process will help medical device companies across the country.

And, so far, the feedback from the medical device industry has been positive. In fact, the Advanced Medical Technology Association (AdvaMed) has expressed its strong support, praising the senators for introducing legislature aimed to modernize, and optimize the process.

What do you think of the bill? Do you agree this will help remove regulations that hurt the medical device industry? Share your thoughts with us!

Topics: De Novo Process, SET Device Act


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