shimonv
Trusted Information Resource
Hi Everyone,
Some of you may know this draft guidance:
"Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device"
It is interned to replace the current version (from 1997).
Does anyone know when will it become effective? and which parts of it?
If implemented "as is" it will make our lives more difficult and, in may opinion, won't make medical devices more safe & effective to use...
Thanks!
Shimon
Some of you may know this draft guidance:
"Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device"
It is interned to replace the current version (from 1997).
Does anyone know when will it become effective? and which parts of it?
If implemented "as is" it will make our lives more difficult and, in may opinion, won't make medical devices more safe & effective to use...
Thanks!
Shimon