Can Consumers Collect Their Own Biological Specimens for Direct-to-Consumer SARS-CoV-2 Tests? FDA Says ‘No’ to Clinical Labs Announcing Such Tests

Following criticism over delays in authorizing medical LDT COVID-19 tests, the FDA swiftly shut down consumer at-home specimen collection schemes Banning COVID-19 tests that rely on consumers’ collecting their own specimens at home is one example where the federal US Food and Drug Administration (FDA) took remarkably swift action. It’s also interesting to note how […]
Source: Dark Daily - Category: Laboratory Medicine Authors: Tags: Compliance, Legal, and Malpractice Instruments & Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operations anatomic pathology CDC centers for di Source Type: news