I am aware that 21CFR820 need to be complied with, but could someone help me with specific requirements and where to get started

Start with 21 CFR part 820 Medical Devices; Current Good Manufacturing Practice (CGMP); Final rule.
Review the regulation to determine how it fits with your device and manufacturing process.

Here are a few documents to review:

1. IVD Directive for the CE Mark
2. CLSI guidelines (old NCCLS guidelines) for validation of assays
3. CLIA
4. FDA Guideline for IVD manufacturer (http://www.fda.gov/cdrh/comp/918.pdf

Hi Phil, our study is presently completed phase 1 and have just touched base with FDA , for pre-IDE, so i just need to know the quality assurance that we need to implement /and is it mandatory to follow ICH-GCP guidelines , /and to start of with the required documents for clinical trials at this stage

Thanks! is it possible for you to give guidance on statistical requirements to comply to FDA

Just a comment about standards, guidance documents, and guidelines, as far as FDA IB/CB are concerned. These are all voluntary on the part of the manufacturer. All FDA manufacturers have to comply with all applicable FDA laws and regulations by law (such as the FD&C Act and 21 CFR sections). Remember, the preamble to each CFR section is a part of the regulation too. However, FDA will not penalize a company if it follows/does not follow a certain standard, guidance document, or guideline--- UNLESS ONE STATES IN THE WRITTEN PROCEDURES THAT THESE SPECIFIC STANDARDS, GUIDANCE DOCUMENTS, AND GUIDELINES ARE TO BE FOLLOWED.

so do you mean that unless the procedures are not specified in the SOPs , it is not mandatory to comply with the guidelines given by the FDA

so do you mean that unless the procedures are not specified in the SOPs , it is not mandatory to comply with the guidelines given by the FDA

Yes! The only thing companies (who have FDA regulated products) are required to follow are the applicable US laws (such as the FD&C Act) and the regulations (such as 21 CFR 800 series). Unless these laws and regulations, (including preambles to the regs as noted in the federal registers), state to follow specific standards and guidelines (which I am not aware of any), you have the discretion to follow a guideline or standard. Guidelines are documents that note the Agency's current thought processes (i.e. think FDA HQ not field offices). If you can come up with a better way of doing "X" (than what is noted in a guideline or standard), then go for it. (This is one area that makes FDA different than a Notified Body.) Of course you'll have to justify the method via a validation study (to see if it indeed works) before seeing that it behaves consistently overtime to meet your predetermined specifications- unless you choose an FDA recognized standard of course and this standard states to conduct a validation study (i.e. against your product or predetermined specification). However, you can not deviate from what is in the FD&C Act or the regulations, but add to them accordingly. That's why the QSR is an umbrella regulation. It's made for everyone- from a class I exempt initial importer to a class III manufacturer.

Thanks Goe for your valuable advice and my apologies for not being in touch, so presently our company is just preparing ourselves for the phaseII trial, and we have the ethics approval and in the process of preparing all the documents as per ICH/GCP and FDA regulatory requirements, if u could suggest templates for preparing these documents it would be helpful.