MDUFA IV

The Role of Patient Preference in Medical Device Evaluation

By Bonnie Odom on May 23, 2019

Posted in FDA, Health Information Technology, Medical Device

When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?

On May 3, 2019, FDA established a docket to collect public input on a…

FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices

By Matthew Sprankle on January 16, 2019

Posted in FDA, Medical Device

On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request.…

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MDUFA IV

The Role of Patient Preference in Medical Device Evaluation

FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices

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