Apr 25, 2011
The US Food and Drug Administration’s Office of Combination Products (OCP) has updated its guidance on Request for Designation (RFD) documents submitted by manufacturers or their sponsors in order to determine how to classify their devices.
The revised guidance spells out more clearly what information the OCP requires within an RFD in order to more promptly determine whether a product should be regulated as a drug, device, biological product or combination product.
The OCP recommends that manufacturers submitting RDFs make especially sure to include the following information:
The revised guidance was prompted by changes to US federal regulation 21 CFR Part 3 involving the definition of PMOA.
A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.
The US Food and Drug Administration has extended its comment period to November 28, 2011 for guidance the agency issued
FDA regulations dictating informed consent requirements for drug and medical device clinical trials are set to change on March 7, 2012.