Regulatory Focus™ > News Articles > Senator Brown Proposes Modifications to the De Novo Process

Senator Brown Proposes Modifications to the De Novo Process

Posted 06 December 2011 | By

On 5 December, 2011, Senator Scott Brown (R-MA) introduced S. 1943, the "Novel Device Regulatory Relief Act of 2011."  The bill is intended to amend section 513 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") to expedite the process for requesting de novo classification of a device.  Senator Brown's bill builds on and clarifies language proposed by Rep. Brian Bilbray in October to modify the de novo process.  Both bills include language allowing a sponsor to submit a de novo classification request without awaiting a written determination from the US Food and Drug Administration (FDA) that the device is not substantially equivalent ("NSE") and therefore classified into class III, even if the manufacturer knows there is no appropriate predicate.  If passed, the bill would simplify and streamline the process medical device makers must go through to request de novo classification. (FDA Law Blog)

Regulatory Focus newsletters

All the biggest regulatory news and happenings.