Berater für internationale Zulassung
If a medical device does not (or no longer) meets the FDA’s requirements, manufacturers, distributors, and importers must recall it. This applies in particular if the device presents a hazard. In this article you will learn, 1. What is a recall? 1.1 The FDA’s definition of the term recall A recall is a way for…
DetailsAbbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you, 1. Abbreviated 510(k) and other approval procedures If manufacturers want to market their medical devices in the U.S., they must go through one of the approval procedures. Among the most commonly used are the Premarket Notifications PMN. These…
DetailsIn 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. 1. What a software change is a) Software changes in the “scope” of the guidance document By a…
DetailsThe 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. Consensus…
DetailsWith the Pre-Submission Program (“Pre-Sub” for short), the FDA offers a formal procedure for manufacturers to clarify their regulatory strategy and specific questions before actual approval or market clearance. A pre-sub request is suitable in the preparation of 510(k)s, De Novo Requests, or PMAs, among other things. This can avoid unnecessary costs and effort on…
DetailsThe 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.” Design History File The FDA requires…
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