Abbreviated 510(k) – When the abbreviation is allowed
Abbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you,
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Berater für internationale Zulassung
Software change: What the FDA expects from you
In a guidance document, the FDA explains how to implement a software change in a regulatory-compliant manner. It describes when you need a new 510(k) submission (Premarket Notification) and when you “only” need to document the changes.
DetailsRecognized consensus standards of the FDA
The FDA offers manufacturers the opportunity to use so-called recognized consensus standards for the approval of their devices. The US authority has published a “guidance” document on these consensus standards, presented in this article. It also describes the requirements for using the standards and the advantages for manufacturers, but also points out typical mistakes.
DetailsDesign History File: Device Master Record, Device History Record
The FDA requires a Design History File DHF in 21 CFR Part 820 (these are the “Quality System Regulations”). DHF should not be confused with the Device History Record DHR or the Device Master Record DMR. This article explains what the Design History File must contain and how it differs from the other two “files.”
