In July, the House of Representatives passed H. R. 6, the 21st Century Cures Act, by a bipartisan margin of 344 – 77. Prior to House passage, the bill was passed out of the House Energy and Commerce Committee by a unanimous vote.
The bill is a pastiche of a variety of healthcare-related issues presented under a bipartisan umbrella, including a revision to at least one FDA performance standard.
Section 2228 of the bill gives HHS a year to produce draft guidance revising section V in its January 2008 guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” This draft guidance is also required to include advice on the “appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.” Section 2226 would require panels determining medical device classifications to have “adequate expertise” to evaluate the technology and the disease or condition that the device treats or diagnoses.
The bill now awaits action in the Senate Health, Education, Labor, and Pensions (HELP) Committee no sooner than fall 2015. The HELP Committee has made noises about drafting its own freestanding bill. To date, however, no companion Senate bill has been introduced.
In other federal developments, debate continues over a proposal to give the U. S. Food and Drug Administration oversight over so-called “laboratory developed tests” (LDTs). This debate has often been referenced as “CLIA modernization” by observers. Whether or not the exact meaning of this phrase changes as events unfold remains to be seen.