Posts by SebastianFeye


In 2011, Marc Andreessen, a venture capitalist, stated “Software is Eating the World”. Ten years later, software development has accelerated and expanded  industries that could not have been imagined a decade ago. Automated medical devices are central to this phenomenon and complex software programs with increasingly advanced algorithms are designed to operate with hardware in order to fulfill its intended use.  These...

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The Food and Drug Administration (FDA) primary responsibility is the enforcement of the Federal Food, Drug and Cosmetic (FD&C) Act that tasked the agency with protecting and promoting public health and authorized the “legality of an FDA inspection, conducted at a reasonable time, within reasonable limits, and in a reasonable manner, depends not on consent but on the validity of statutory authority.” (Compliance Policy...

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In late 2019, the FDA introduced a new Safety and Performance Based Pathway which can potentially speed up the preparation and review process for certain submitters of pre-market notification medical device submissions. This optional pathway was created by the FDA to assist with well understood device types, in which a submitter references device specific guidance’s detailing the appropriate testing standards, as well as defined...

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Updated: March 26, 2021 – FDA has stated that MDF facility fees will be $20,322, and CMO facility fees will be $13,548. Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and other general...

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Due to the COVID-19 pandemic, world-wide demand has soared for hand sanitizer and anti-viral products. Below, we outline five basic steps for domestic and foreign manufacturers or domestic distributors who want to get their drug product into the US market but never dealt with the FDA’s electronic drug registration and listing. The scope of products includes: Rx (Prescription Drugs) and OTC (Over the counter) – ex. Hand Sanitizer,...

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