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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.