It may be helpful to reference recognized standards and guidelines for testing specific variations. We recommend that your controls include wild type DNA in addition to the gene variations your device contains. In this way your device will contain both positive controls (e.g., mutations, variants...
Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode Optional Interlocks - Labeling (Laser Notice 17) Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) 1987 Final Guidances: Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)...
Two qualitative IVDs are available for testing CSF specimens for EV: Xpert EV (Cepheid) and NucliSENS EasyQ Enterovirus (bioMérieux, l'Etoile, France). The Xpert EV assay is performed on a GeneXpert System (Cepheid). In a multicenter evaluation of 102 CSF specimens, the assay had a sens...
Essentially, the CDS must be able to describe and support the rationale for any recommendations it issues, such that the clinician could independently arrive at the same conclusion on his/her own, using publicly available information (e.g., treatment guidelines or published literature). In other ...
And FDA's rule does not affect your use of those standards or guidelines and, in fact, implicit in the rule is the notion that you will appropriately follow and meet these guidelines. However, FDA has stated that there are three times when you must assign a new DI: 1. When you make ...