The FDA has proposed a change that will seriously limit the usefulness of the online database that is supposed to collect and categorize medical device malfunctions by product. In many situations, this is the only source of information patients can use to investigate the dangers of medical devices that their doctors propose to use. (Many doctors are not even aware of this database.)
Comment period ends 2/26, and you can comment here: https://www.regulations.gov/comment?D=FDA-2017-N-6730-0001
If you’re a twitter user, I wrote up the changes, and included my written comment to FDA here: https://twitter.com/SafePatientAdvo/status/966398443823407105
I don’t know how useful these comments are, but they certainly can’t hurt. Please tell them not to make this harmful change.