Survey: Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation

Apr 19, 2022 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Testing

Though response was limited in Dark Daily’s poll, the message from respondents was overwhelmingly negative on LDT regulation by the FDA Most respondents to a recent industry survey said that should Food and Drug Administration (FDA) approval be required in the future for laboratory developed tests (LDTs), innovation will suffer. This conclusion echoes what opponents of the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) have argued will happen should that proposed bill...

LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

Mar 29, 2022 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Testing, Uncategorized

Survey respondents can give their opinions about the proposed VALID and VITAL acts Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written. An LDT is a proprietary diagnostic test developed and performed by...
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