CAP Proposals for LDTs Highlighted

CAP Opposes Complete FDA Enforcement DiscretionBefore certain high-risk, life-sustaining medical devices like implantable pacemakers and defibrillators become commercially available, they are subjected to the Food and Drug Administration's (FDA's) premarket approval process to reasonably assure their safety and effectiveness. However, until recently, the FDA has exercised "enforcement discretion" over a subset of in vitro diagnostic products called laboratory developed tests (LDTs ).  While