FDA quality pilot aims to streamline device review process

An FDA pilot will zero in on attributes critical to device and process quality.

The FDA is piloting a new scheme for high-risk medical devices that removes the need for preapproval inspections in return for making more information on device quality available early on.

The aim is to target the regulator's premarket approval and post-marketing inspections more effectively, and "promote quality in device design and manufacturing," which in turn should reduce device failures and recalls, says the agency in a Federal Register post.

The Premarket Approval Application Critical to Quality (PMA CtQ) pilot is looking for nine device manufacturers willing to collaborate with FDA on identifying the characteristics of a device that are most important for the quality of the product as well as the process used to manufacture it.

This type of risk-based, critical quality attribute approach is already well established in the pharma industry for active ingredients and excipients, but to date has not been formally made a feature of interactions between the FDA and medical device manufacturers.

The pilot has been prompted by feedback on the agency's inspection process by device companies which has "indicated that FDA can improve its approach for medical device inspections by focusing on areas critical to quality of the device, which in turn will change the compliance focus to influence better device quality."

Feedback has also suggested that many of the risks associated with a device "reside in product and process design and post-production activities."

The pilot is due to get underway on Sept. 29 and will run through the end of 2018 unless it takes longer to complete the process with all nine manufacturers.

"The pilot program is intended to provide qualifying PMA applicants with the option to engage FDA on development of CtQ controls for their device and forego the standard PMA pre-approval inspection," says the notice. "FDA would in turn, focus on the PMA applicant's implementation of the CtQ controls during a post-market inspection."

The hope is that an additional benefit of shifting inspections post-market will be to streamline the PMA process, and thus shorten time to market for device manufacturers.

FDA was roundly criticized a few years ago for lengthy review times for medical devices, with manufacturers claiming that the delays were handing commercial opportunities to overseas competitors, with a General Accounting Office report also highlighting shortcomings in the process that could allow faulty devices to reach patients.

The agency has been trying to improve matters, and two years ago a report suggested it had cut review times for low- and medium-risk devices from 132 days in fiscal 2010 to 115 days in fiscal 2014, with the times for high-risk devices decreasing from 352 to 242 days over the same period.

Since then the introduction of an expedited access PMA for breakthrough devices has helped to improve speeds further, and the introduction of user fees is also expected to lead to improvements.