The Final Rule

The Final Rule


Final Rule Book



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What is The Final Rule?

The Agency published the Final Rule for the Quality Systems Regulation (21 CFR Part 820) in the Federal Register on October 7, 1996 (Volume 61, Number 195). Rick took the raw electronic file, cleaned it up and published it in a book format for his personal use. After coworkers learned of the book, he provided copies to medical device investigators in the Kansas City District. He willing shared the file with firms that he inspected. In the latter section of the Final Rule Book, placed beside each paragraph or sub-paragraph is the comment number(s) with the page(s) in parentheses the comments that address where comments on that section may be found.

The Final Rule, when published, provided a Summary which included the Background, Decision to Make a Working Draft Available for Comment, Open Public Meeting and GMP Advisory Committee Meeting, Implementation of the Final Rule, and Response to Comments and Rationale for Changes.

The Response to Comments and Rationale for Changes is where the Agency responded to all comments that had been submitted to the Working Draft. This section of the Final Rule is very significant in that the every section and sub-section of the Part 820 is addressed. The Agency summarizes a single comment, a few comments or multiple comment of similar nature (and sometimes with a variation added). Regardless of which section a comment or question is posed to the Agency, the question(s) / comment(s) are addressed. The Agency either agrees and states their response, agrees in part and explains its position, or disagrees and states why they do not accept the comments. This book provides the Agency’s intended understanding of what is written in Part 820. The final section of this Final Rule is the complete text of 21 CFR Part 820 that one would find in the 21 CFR Book 800 Series.

The Agency may have addressed a single issue, e.g., design control, device master records, etc., under multiple paragraphs or sub-paragraphs, wherever the commenter submitted the comment. The Agency will have explained the relationship of the comment related to that section, explained the move of a section to other paragraphs, or other responses. These comments are difficult to find without a reference point.

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“I have been trying to use your handbook instead of the Kim Trautman {book} whenever possible. Using your handbook, one is less inclined to resort to opinion when making a close call. I like it because the people I work with can see where I am coming from much easier.”

April 5, 2016