Why take this course?
Preparing a 510(k) now requires more than assembling familiar sections in a new format. Since October 1, 2023, submissions must go through FDA’s eSTAR portal, which changes how teams organize, enter, and present the same core content FDA expects for review. For new or substantially changed medical devices, the quality of predicate selection, supporting documentation, and submission structure directly affects how efficiently the package moves into review.
The underlying purpose of the 510(k) remains unchanged: to establish safety and effectiveness through a documented and tested comparison between the subject device and an appropriate predicate. That makes predicate strategy and documentation architecture central to the submission, not secondary tasks. Teams need a clear view of the legal framework, the major submission sections, and the technical material required to support a complete package.
Additional complexity now enters through cybersecurity expectations, machine learning and artificial intelligence features, and newer program pathways such as Breakthrough, STeP, and Q-Sub. Post-market obligations also remain part of the broader submission context. This program organizes those moving parts into a structured view of what is required to prepare a 510(k) package under current FDA electronic submission requirements.
Key Areas Covered
John E. Lincoln
John E. Lincoln has more than 40 years of experience in FDA-regulated industries, including extensive work on new and changed product 510(k)s, regulatory affairs, FDA responses, and design and technical files. His background connects directly to predicate strategy, submission documentation, and the practical preparation issues involved in current FDA device marketing submissions.
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