Hi All,
I'm hoping someone here can help me better understand the FDA regulations regarding Special Controls for Class II medical devices.
As I understand it Special Controls are required for Class II devices and include Performance Standards, Post-market Surveillance, Patient registries, Special Labelling requirements, etc
CDRH has developed special controls guidance documents that specify requirements for individual devices. These Guidance documents are not available, however, for all or even the majority of Class II devices.
(Note: Product I am working on is a Powered Muscle Stimulator (Sec. 890.5850) and whilst a draft Class II Special Control Guidance Document was drafted in April 5, 2010, it was withdrawn on 27th Apr 2015.
Question 1:
In the absence of a special controls guidance document, what documents the particular special control requirements for a device?
Question 2:
There is now a Medical Device exemption list for Class II devices. How does the FDA decide which devices are exempted? Is it possible to propose a device for exemption?
(Note: While 890.5820 devices are not on the exemption list some others that are very similar are on the list.).
I'm hoping someone here can help me better understand the FDA regulations regarding Special Controls for Class II medical devices.
As I understand it Special Controls are required for Class II devices and include Performance Standards, Post-market Surveillance, Patient registries, Special Labelling requirements, etc
CDRH has developed special controls guidance documents that specify requirements for individual devices. These Guidance documents are not available, however, for all or even the majority of Class II devices.
(Note: Product I am working on is a Powered Muscle Stimulator (Sec. 890.5850) and whilst a draft Class II Special Control Guidance Document was drafted in April 5, 2010, it was withdrawn on 27th Apr 2015.
Question 1:
In the absence of a special controls guidance document, what documents the particular special control requirements for a device?
Question 2:
There is now a Medical Device exemption list for Class II devices. How does the FDA decide which devices are exempted? Is it possible to propose a device for exemption?
(Note: While 890.5820 devices are not on the exemption list some others that are very similar are on the list.).
