WASHINGTON, DC, August 30, 2011The Association for Molecular Pathology (AMP) submitted comments to the US Food and Drug Administration on the draft guidance document titled, "Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions."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accommodations for low test volume or sufficient time for manufacturers to achieve submission compliance, the draft guidance document could result in reduced availability of testing services would limit a healthcare provider's ability to manage patient care, and ultimately limit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.
"Some products used for laboratory tests are available only as research or investigational use only products," explained AMP Professional Relations Chair Dr. Elaine Lyon. "If this guidance were to be finalized, we're concerned that patients won't be able to access tests such as those for Hepatitis C genotyping, newborn screening and HLA testing," added Dr. Lyon.
AMP supports FDA clearance and approval of research use only (RUO) and investigational use only (IUO) products, especially test kits and test systems. However, to prevent disruption of patient care, accommodations should be made to ensure continued patient access to critical tests as manufacturers come into compliance and/or instances where low test volume would deter a manufacturer from submitting an application to the FDA for that product.
"While AMP appreciates the FDA concern over the use of RUO and IUO products in laboratory developed tests, the Association questions the underlying assumption that the guidance will en
|Contact: Don Hunt, Lambert, Edwards & Associates|
Association for Molecular Pathology