I don't believe I've met Xander van Wijk, a Houston-based regulatory consultant. His Linked-In postings include some great resources on the FDA LDT issue.
23 Slide Deck on FDA LDT
Earlier this summer, he posted an excellent (right-sized) 23-slide deck on the FDA LDT final rule. It's a good balance of digestible size and yet incorporated many great-to-know details. Read all the way through to Slide 23 for an excellent table of all the requiresments x all the numerous test categories.
Webinars What's Up
See also a new post by van Wijk that summarizes some very recent activiies (like the FDA August 22 webinar) and also, provides a guide to upcoming webinars in the field.
At this latter link, you can get to...
- A CAP webinar on the FDA LDT rule on September 18.
- An FDA webinar on LDT labeling requirements on September 24.
- An ADLM webinar on "Complying with FDA" on September 25.
The FDA webinar doesn't require pre-reg and the FDA fully archives its webinars and decks on the LDT subject.
