James Boiani Featured in “US FDA Agrees to CLIA Waiver Process Reforms, but More Is Needed, Coalition Says”Medtech Insight September 22, 2016
James A. Boiani, a Member of the Firm, in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Medtech Insight, in “US FDA Agrees to CLIA Waiver Process Reforms, but More Is Needed, Coalition Says,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
The CLIA waiver process is designed to determine if tests are simple and error-proof enough to be used by "waived" labs such as doctor's offices and health clinics, as well as at the bedside at hospitals. It's the regulatory pathway that drives the growing point-of-care testing market.
"It's like there's a hole in the boat and we've got a Dixie cup now to help bail it out, but we know we need to fix the hole," said James Boiani, an attorney with the law firm Epstein Becker Green, who founded the Coalition for CLIA Waiver Reform in 2014 to push for changing FDA's underlying standard for granting a CLIA waiver, an issue not addressed in the user-fee agreement. (Also see "Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform" - Medtech Insight, 6 Jun, 2014.) But it is an issue that has received attention in ongoing deliberations in the US Congress.