PREFER patient input to decision making under evaluation

2023-03-29T15:51:23+00:00October 16th, 2021|Categories: Digital Health, Europe, Regulatory|Tags: , , , , , , |

PREFER project has developed a framework with points to consider when selecting methods for industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical product decision making. European Medicines Agency and EUnetHTA - European Network [...]

Electronic Submission Template for Medical Device 510(k) Submissions

2024-02-02T10:49:34+00:00September 30th, 2021|Categories: Digital Health, FDA, Innovation, Software|Tags: , , |

On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days. The Guidance introduces the electronic Submission Template and Resource tool eSTAR, which [...]

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