The Regulatory Blueprint
FDA Compliance and Quality System Analysis
Analysis
Purchasing Control Citations Rose 19% in FY2025
What the FDA’s inspection records show about supplier oversight and what they cannot yet show about the QMSR.
Read the ArticleWhat the QMSR Adds to ISO 13485:2016
21 CFR Part 820 has required a quality system that complies with ISO 13485:2016 since February 2, 2026. The part adds a short set of FDA-specific requirements.
Read the ArticleCAPA Root Cause and Effectiveness Checks
A CAPA closed on implementation leaves the effectiveness review undone. Defining the check before the investigation starts shapes the root cause that follows.
Read the ArticleDesign Change Routes: 510(k), PMA Supplement, or Documentation
21 CFR 807.81(a)(3) and 21 CFR 814.39(a) set the triggers for a new 510(k) and a PMA supplement. A change that meets neither still needs a documented decision.
Read the ArticleNo posts match both filters. Clear one to see more.
Recent LinkedIn Posts
Follow VSG on LinkedIn
On September 18, 2026, the FDA issued draft guidance that would require the eSTAR for original PMAs and four kinds of PMA supplement, including 30-day notices.View on LinkedIn ↗
Complaint files used to be 21 CFR 820.198. That section was removed from Part 820 on February 2, 2026.View on LinkedIn ↗
Feedback on the FDA's generative AI discussion paper closes on Monday October 19, 2026.View on LinkedIn ↗
The FDA has issued draft guidance on what a company submits to market a surgical robot.View on LinkedIn ↗
Analysis Updates
Sign up once and we’ll email you each time a new Regulatory Blueprint piece is published.
Notify Me on Update