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 entire process of bringing a...
Read MoreCategory: Regulatory Submissions
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 marketing clearance from FDA for...
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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 a new option for medical...
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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 improve and modernize the process...
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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 Based Pathway which can potentially...
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