M
Those of you who might want to formulate your dissatisfactions with the present 510(k) system into justified suggestions for improvement, may want to know about a new FDA improvement project, "Strengthening the Center for Devices and Radiological Health's 510(k) Review Process.''
The announcement is here.
A public meeting will be held in the metro Washington DC area on February 18th. Comments by mail or email will be accepted until March 5th. Section III of the announcement has a long list of substantive discussion proposals.
Obviously there's a high level of awareness at FDA of some of the issues involved, and a willingness to consider changes. This is an opportunity to present substantial proposals to those who...if they agree as to merit...could greenlight them.
The announcement is here.
A public meeting will be held in the metro Washington DC area on February 18th. Comments by mail or email will be accepted until March 5th. Section III of the announcement has a long list of substantive discussion proposals.
Obviously there's a high level of awareness at FDA of some of the issues involved, and a willingness to consider changes. This is an opportunity to present substantial proposals to those who...if they agree as to merit...could greenlight them.