Steven J. Gonzalez

Get The 4-1-1 On Your 1099s: 5th And 7th Circuits Permit Paying Volume-Based Compensation To Independent Sales Agents

Federal District Court Vacates FDA's Laboratory Developed Tests Final Rule

Warning Letters: An Untapped Source For Understanding When Device Changes Require A New 510(k)

Keeping Your Company's Federal Contracting Options Safe In The Face Of Pending BIOSECURE Act Legislation

FDA Phones A Friend: Joint Statement With CMS Eschews CLIA Modernization And Supports FDA Oversight Of LDTs

FDA Can't Reclassify Its Way Out Of Reviewing 100,000 LDT Submissions

Outlining The Legal Arguments Against FDA's Proposed Rule Regulating LDTs

Conference Notebook: Reporting From FDLI's 2023 Enforcement, Compliance, And Litigation Conference

A Question 30 Years In The Making: Would A Final LDT Rule Withstand Judicial Scrutiny?

AI/ML-enabled Medical Devices Have Everyone's Attention, Including FDA's