The challenge of 510(k) De Novo submission decision

Rami.Azulay March 8th, 2011 Posted by Rami Azulay( ) Software Lifecycle Management

There is a real challenge for a medical device company whether to go for 510 (k) De Novo submission.

First – lets understand some facts :

  • For some historical reason – there is a dependency between risk level (Class I, II and III) and submission required  (510(k)/PMA)
  • For risk level of class I and II – the medical device company is required to be 510(k) cleared
  • For risk level of class III – a PMA submission is required

But what is the case when the product is not based on exisitng product and the risk level is not Class III?

If the company succeeds to prove this claim – a 510(k) De Novo submission is allowed

This submission process expose the comapnies to competition. Once the company is 510(k) De Novo cleared – it means that their product is an existing product…. now the competitors can create a competitive product and submit the 510(k) based on the “existing” company product. Another issue is the efforts need to be invested in order to convince the FDA that the risk level is not class III.

and finally – there is a risk in the exposure of the company IP by the FDA during the risk level re- evaluation process.

Due to these reasons the medical device company sometimes choose to go for the PMA.


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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