Q
Hello Fellow Quality Gurus,
First, please don't shoot me if I didn't read all of the threads that exists about this topic. If I missed it, I'm sorry. Just asking for help and direction.
I want to make sure that I understand this correctly of the following statement. One of our devices is a Class 1 product with exemptions:
"FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).
So does this mean that its ok to avoid doing the design control process because of this statement? Are there any of you that do this in the company? Do you not document the development of new products at all if you have somehow already determined it is a class I device? I'm in a company where they are looking at all together to save time in the development process and avoid doing the thing that takes a while to do --- document and develop sound verification/validation, and laborious testing. I'm all for streamlining. But I have to ask - does that work? In the end how else do you capture decisions and thoughts throughout the process as well as intellectual property?
First, please don't shoot me if I didn't read all of the threads that exists about this topic. If I missed it, I'm sorry. Just asking for help and direction.
I want to make sure that I understand this correctly of the following statement. One of our devices is a Class 1 product with exemptions:
"FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).
So does this mean that its ok to avoid doing the design control process because of this statement? Are there any of you that do this in the company? Do you not document the development of new products at all if you have somehow already determined it is a class I device? I'm in a company where they are looking at all together to save time in the development process and avoid doing the thing that takes a while to do --- document and develop sound verification/validation, and laborious testing. I'm all for streamlining. But I have to ask - does that work? In the end how else do you capture decisions and thoughts throughout the process as well as intellectual property?