I found one enthusiastic champion in our Center for Devices, Ann Hawthorne, who held a series of Brown Bag lunches for her Center's reg writers, where she covered several different PL techniques. She developed this checklist for her writers.

Plain English Checklist for Guidance Documents

___ written for the average regulatory, scientific, or clinical reader
___ organized to serve the reader's needs, not the writer's
___ uses no more than 3 subordinate levels, for example, I. A. 1.
___ uses "you" and "we"
___ uses active voice
___ uses short sections and sentences
___ contains no deadwood, e.g., redundancy, extraneous facts or details
___ written to one person, not a group
___ written with nouns in the singular, e.g., a device, a submission
___ uses the simplest tense possible
___ avoids "would" and "could"
___ uses "must" only for things required by regulation or statute
___ places words carefully ( e.g., subjects and verbs are together)
___ organizes topics carefully, general to specific, things of a kind
___ uses lists instead of sentences to list three or more items
___ avoids confusing sentence constructions

As a result of these training sessions, we have seen real improvement in their documents. But I'll admit that agency-wide, the biggest improvement is often not with our regs, but with our Guidance Documents - which is OK, since they are probably read more often that the regs are, by people who need to comply with FDA rules.

Our public affairs writers nearly always do a good job, so that's not where I put my efforts. Rather, I decided to preach the benefits of being kind to each other with-in the FDA, and encourage folks to improve our internal documents. As Edie Schwager of the American Medical Writers Association says, "Clarity begins at home."

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