Monday, June 20, 2016

21 CFR 803 displays "plain language" from 2005 to current

Not many realize that in 2005, the FDA made a significant change in the language about Medical Devices. The  plain language was introduced in the Federal Register February 28, 2005. In essence, the language changed from "statutory" to "plain English, by adding the "plain language" below the "statutory." Then, after 2005, the language is all in "plain language" for 21 CFR 803.

It is in the 2005 CFR that you will see both versions, "statutory" and "plain language." Going forward, the language is "plain language" from 2006 to current.

Here is the rationale from the Federal Register, 70 FR 9516.

"SUMMARY: The Food and Drug Administration (FDA or we) is amending its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a
companion proposed rule, under FDA’s usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. DATES: This rule is effective July 13, 2005,"

What is the General Approach?

"In this direct final rule, FDA does not change the existing regulatory requirements described previously in this document. FDA is revising part 803 solely to ensure that despite the many revisions that have been made, part 803 is clear and easy to understand. To achieve this goal, we have rewritten part 803 into plain language, in accordance with the Presidential Memorandum on Plain Language, issued on June 1, 1998. That memorandum directed the agency to ensure that all of its documents are clear and easy to read. Part of achieving that goal involves having readers of a regulation feel that it is speaking directly to them. Therefore, we have attempted to incorporate plain language in this rule as much as possible. We have tried to make each section of the companion proposed rule easy to understand by using clear and simple language rather than jargon, by keeping sentences short, and by using active voice rather than passive voice whenever possible. We have also made changes to improve the consistency of the format and language used throughout parallel regulations governing user facilities, importers, and manufacturers that were added or amended at different times. We do not intend these changes to have any effect on the substantive requirements of part 803."

So if you don't see the statutory language, but a simpler language for 21 CFR 803 after 2006, you will know why.

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