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Best practices for navigating your medical device 510(k) regulatory strategy and submission plan The medical device industry knows that obtaining marketing clearance from FDA for...
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A new program that FDA has authorized and kicked off is an accreditation program bringing to the medical device industry a new option for medical...
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As technology and computing become increasingly embedded throughout the life sciences industry, more and more medical devices rely on software and network communications to deliver...
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Originally Published on January 12, 2023 by Sebastian Feye In September of 2018, the FDA took their first step to improve and modernize the process...
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Originally Published on April 22, 2021 by Sebastian Feye Acronyms: TPLC – Total Product Lifecycle AI/ML- Artificial Intelligence and Machine learning SaMD – Software as...
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Originally Published in November 18, 2020 by Sebastian Feye The Food and Drug Administration (FDA) primary responsibility is the enforcement of the Federal Food, Drug...
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Originally Published in August 31, 2020 by Sebastian Feye In late 2019, the FDA introduced a new Safety and Performance Based Pathway which can potentially...
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Published Originally in June 22, 2020 by Sebastian Feye Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing of non-prescription drug products not...
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Posted originally December 10, 2019 by Sebastian Feye 21 CFR Part 11 – Electronic Records Part 11 of the Code of Federal Regulations applies to...
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Posted originally July 31, 2019 by Sebastian Feye Today I had the opportunity to listen into a PricewaterhouseCoopers (PwC) webinar hosted by SDRAN discussing how...
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