Comment from Enrique A Gonzalez
AnonymousOpposeIndividual
Summary: Enrique A Gonzalez Guerra expresses concern over the negative economic impact caused by the elimination of the 510(k) clearance requirement for certain Class II medical devices. He argues that the lack of timely information and transparency regarding these changes has hindered his ability to work and calls for better communication in the regulatory process.
Dear Department of Transportation,
I am contacting you to express my concern and the negative impact that the recent FDA notice regarding the elimination of the 510(k) clearance requirement has had on my work life.
In my case, the lack of timely information about these changes has led to a situation in which I cannot work, directly affecting my economic stability and that of my family. Additionally, I want to point out that I was not informed about a positive result that turned out to be false.
I consider it fundamental that better communication and transparency be guaranteed in these processes to prevent other participants from suffering similar consequences.
I appreciate your attention to this matter."
Enrique A Gonzalez Guerra
450 Holt Ave. Apt. 111
Holtville, CA. 92250
442 231 4669
Dear Department of Transportation,
I am contacting you to express my concern and the negative impact that the recent FDA notice regarding the elimination of the 510(k) clearance requirement has had on my work life.
In my case, the lack of timely information about these changes has led to a situation in which I cannot work, directly affecting my economic stability and that of my family. Additionally, I want to point out that I was not informed about a positive result that turned out to be false.
I consider it fundamental that better communication and transparency be guaranteed in these processes to prevent other participants from suffering similar consequences.
I appreciate your attention to this matter."
Enrique A Gonzalez Guerra
450 Holt Ave. Apt. 111
Holtville, CA. 92250