Health Law Advisor

MAY 2, 2023

Word Count and Importance of Topic Keywords As I explained last month, some of those topics are easier to understand and interpret than others. They are apparently asking for enforcement related documents that led up to the warning letter. The ones that seem to fall into somewhat defined categories include the following: 2.

FDA 52

FDA 52

Exeed Regulatory Compliance

FEBRUARY 25, 2020

At home, at work, and in public places, we are using devices and systems that are connected to the internet and to each other. Strengthen post-market surveillance – Risks related to security and safety of interoperable devices are expected to evolve over time as these devices are used in diverse clinical situations.

FDA 52

FDA 52

Health Law Advisor

SEPTEMBER 5, 2023

Out of that list of snippets, I pulled out all of those snippets that had one of the keywords that I cared about in it. Having said that, there are plenty of instances where devices are cleared without 95% in at least some accuracy related measure. In a sense, the data shared are only those volunteered by the manufacturer.

FDA 111

FDA 111

Health Law Advisor

MAY 3, 2022

I filtered for only those that relate to devices, which produced just over 41,000 citations. Then, to the right of that, merging the data sets on common establishment registration numbers, I add on the device inspections that relate to those manufacturing establishments that received warning letters. Putting the Data in Context.

FDA 52

FDA Compliance 52