Operating system compliant with IEC 62304 and FDA?
When selecting an operating system, do medical device manufacturers have to ensure that the operating system is IEC 62304-compliant? What does the FDA say? This article…
Configuration management for medical devices
Configuration management is much more than using version management tools like git or svn. This becomes clear when you look at IEC 62304 and the FDA guidance documents. In this article, you will read about
DetailsFDA Pre-Submission Program
With 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 eSTAR Program: should or must you take part?
With the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. The Johner Institute is working with the FDA on the further development of eStar. This article tells you how forward-looking this approach is and whether you should or even must take part.
DetailsApproval of medical devices in Brazil
It is not easy to get medical devices approved in Brazil. This is due to the number of regulations, their complexity, and the fact that Brazil has published most of the regulations in Portuguese only. This article provides an overview and highlights similarities with the European and US systems. This will make it easier for you…
DetailsDe Novo Program of the FDA
The De Novo request, which the FDA also refers to as the “De Novo program” and the “De Novo submission process”, is one of the approval processes for medical devices in the United States. As the name “De Novo” suggests, manufacturers can use this process for novel products. In other words, manufacturers should submit a…
DetailsMDR transition periods
In Article 120-123, the MDR establishes its transitional provisions, including the transition periods. However, the descriptions of these transitional provisions and transition periods are worded in a very complex manner. As a result, manufacturers are at risk of misunderstanding them and therefore not complying with regulatory requirements or incurring unnecessary costs. A flow chart in chapter 2 of this article…
DetailsLaboratory products for “Research Use Only” (RUO) – often a dangerous claim
Manufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories still use RUO products in diagnostic procedures, sometimes even with the knowledge…
DetailsProducts for general laboratory use: What manufacturers and laboratories need to know to avoid problems and unnecessary expense
One assumption persists: Products for general laboratory use such as PCR cyclers, NGS devices, fragment analyzers, centrifuges, pipetting robots, and extraction kits must bear a CE-IVD marking. Is this correct?
Accessibility
Accessibility refers to the design of products and services that can also be used by people with physical limitations. The term “products and services” encompasses both physical and digital products and services. This also includes medical devices (physical devices, apps, other standalone software). This article explains which accessibility requirements manufacturers of medical devices should be…
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