Compliance In Focus

What is a guidance document and how should they be used? A guidance document represents the FDA’s current thinking on a topic. Per FDA’s website, guidance documents “do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternate approach if the approach satisfies the requirements of the applicable statues and regulations.” Guidance documents usually discuss FDA’s interpretation of their policy on a regulatory issue.

As a follow-up to yesterday’s blog, here is a list of guidance documents FDA plans to fully publish, and intends to publish in the upcoming fiscal year. Remember, these lists and increased transparency efforts are in part the result of FDA negotiations with industry for the Agency to meet different quantitative and qualitative goals for the medical device industry. This is done in hopes to allow safe and effective devices to the public in a faster, more efficient method.