Devicemakers Should Make Sure Quality Systems Are in Place
With the FDA expected to issue final guidelines on laboratory-developed tests in the coming months, devicemakers should take steps now to ensure their quality systems are in place, an industry expert says.
Registration, listing and adverse event reporting requirements for Class II and III LDTs would go into effect six months after the framework is finalized, and premarket requirements for Class III LDTs would commence six months later, the guidance says.
“So what this means is that in the first six months you’re going to notify FDA of all the LDTs in all of the labs. And then at 12 months, FDA is going to start requiring the labs to provide all of the information to FDA to make it regulated as a medical device,” according to Dan O’Leary, president of Ombu Enterprises, who spoke during an FDAnews webinar in December.
It is essential that devicemakers start work on building a quality system, which will need to be in place and pass inspection before the FDA will approve their first PMA for Class III devices.
It is unclear exactly when the FDA will release the final guidelines. Center for Devices and Radiological Health Director Jeffrey Shuren told a House subcommittee in November that the agency hopes to finalize the documents earlier in 2016, rather than later in the year.
The FDA released draft guidance documents on LDTs last year, focusing on the framework for regulatory oversight and the notification of medical device reporting. Industry criticized the proposed regulation as having the potential to stifle innovation.
Initially, the FDA believed it wasn’t worth the effort to regulate LDTs because they were very limited in use and scope. However, this thinking has changed, as their use is now widespread, particularly in large laboratories, said O’Leary.
The FDA has long asserted that design and manufacture of Laboratory Developed Tests falls under the device regulations. Order our Webinar Preparing for the LDT Regulation: CLIA Won’t Satisfy the FDA, and get the practical information you need to understand the FDA’s intentions. It provides vital information a lab needs to prepare for the change.