Which Tests Are Impacted by New FDA Oversight Rules?

By now, most labs offering laboratory developed tests (LDTs) are aware there are new oversight requirements they must comply with under the new Final Rule recently issued by the U.S. Food and Drug Administration (FDA). But which tests are exempt, if any, and what types of labs are directly affected?
In this webinar short, Gail Javitt, Director at the FDA law firm Hyman, Phelps & McNamara, reviews the full scope of enforcement discretion under the FDA's Final Rule and what exemptions currently exist.
Jump to:
-Categories of enforcement discretion (0:20)
-Key exemptions (1:08)
-LDTs for unmet needs (2:05)
-Currently marketed LDTs (2:22)
-Defining "enforcement discretion" (3:04)
#ldt #medicallab #fda #laboratorymedicine #ivd