Choosing the Wrong Predicate(s) Will Be A Self-Inflected Setback for the Sponsor
Written September 28, 2026 – 8 minute read Some Sponsors may treat predicate selection as a citation exercise in the…
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Regulatory insights, industry news, and expert perspectives
The FDA Pre-Submission Program Will Increase the Probability of Success for Any Future Medical Device Submission
Best practices for navigating your medical device 510(k) regulatory strategy and submission plan The medical device industry knows that obtaining…
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Navigate Medical Device Approvals with the ASCA Program
A new program that FDA has authorized and kicked off is an accreditation program bringing to the medical device industry…
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Medical Device Pre-Market Cybersecurity: An Overview of Threat Modeling
As technology and computing become increasingly embedded throughout the life sciences industry, more and more medical devices rely on software…
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New Pre-market Submission Route: FDA’s eSTAR Program
Originally Published on January 12, 2023 by Sebastian Feye In September of 2018, the FDA took their first step to…
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Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development
Originally Published on April 22, 2021 by Sebastian Feye Acronyms: TPLC – Total Product Lifecycle AI/ML- Artificial Intelligence and Machine…
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An Overview of FDA Inspections across Drugs, Biologics and Medical Devices
Originally Published in November 18, 2020 by Sebastian Feye The Food and Drug Administration (FDA) primary responsibility is the enforcement…
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New Medical Device Pathway: Safety and Performance Based Pathway
Originally Published in August 31, 2020 by Sebastian Feye In late 2019, the FDA introduced a new Safety and Performance…
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Over-the-Counter (OTC) Drug Monographs Reform Summary
Published Originally in June 22, 2020 by Sebastian Feye Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing…
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Part 11 compliance is critical, Firms need to be aware of compliance with using the Cloud
Posted originally December 10, 2019 by Sebastian Feye 21 CFR Part 11 – Electronic Records Part 11 of the Code…
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