FDA draft guidance document may limit patient access to tests
The Association for Molecular Pathology (AMP) submitted comments to the US Food and Drug Administration on the draft guidance document titled, "Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions." AMP is very concerned that this guidance could compromise the quality of patient care by severely reducing the availability of certain reagents and laboratory developed testing services that have become the standard of care for many diseases or conditions. Specifically, if enforced in its broadest sense without sufficient accommodations for low test volume or sufficient time for manufacturers to achieve submission compliance, the draft guidance document could result in reduced availability of testing services would limit a healthcare provider's ability to manage patient care, and ultimately limit patient access to new or improved molecular tests.