FDA
4 posts tagged with “FDA”
21 CFR Part 11 did not change in 2026. Everything around it did.
Part 11 has been stable since 1997. The number of systems it applies to has not. QMSR took effect in February 2026, and the FDA's updated Computer Software Assurance guidance pulled cloud and SaaS tools formally into scope. Here is how to run the checklist so the answers stay true.
503A vs 503B: Turning Regulatory Complexity into Practical Compliance
Navigating the differences between 503A and 503B compounding regulations doesn't have to be overwhelming. Here's what your organization needs to know to build a compliant, inspection-ready quality system.
What is the FDA QMSR?
The FDA plans to align 21 CFR 820 and ISO 13485. There are a number of steps that will be taken to achieve harmonization — here's what you need to know.
![How Long Does the FDA Medical Device Approval Process Take? [Timeline]](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2Fpy379f3b%2Fproduction%2Fd0fadf2044af2c43a94a4f9a316e57f18b49d368-1440x900.jpg%3Fw%3D600%26h%3D375&w=3840&q=75)
How Long Does the FDA Medical Device Approval Process Take? [Timeline]
Learn more about the FDA medical device approval process timeline and how you can ensure that your company won't run out of money before you start...