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.