FDA Pilot Program Helps Manufacturers Streamline Approval of Medical Devices

Jane Akre
September 18, 2017

Mesh Medical Device News Desk, September 18, 2017 ~ The FDA spends much of its resources working with device and drug manufacturers to help ease their way to market.

Here is another example of a newly announced pilot program that will help do just that.

Unlike drugs, high-risk medical devices, even some permanently implanted, make it market with relative ease.

Now the U.S. Food and Drug Administration (FDA) is launching a pilot program that aims to further streamline the premarket approval (PMA) process for some high-risk medical devices.

Published in the Federal Register, the FDA’s Center for Devices and Radiological Health (CDRH) will solicit nine companies to join a pilot program called Premarket Approval Application Critical to Quality (PMA CtQ). The program will run from September 29, 2017 until the end of December 2018.

Flexible Endoscope medical device

The “FDA intends to work with each participating applicant to identify characteristics of its device and its manufacture that are critical to its quality, which may include specific device features or quality control practices. The identified CtQ characteristics and controls will help focus FDA’s post-approval inspection approach.”

Applicants would not be subject to pre-approval inspections of the medical devices, design and manufacture but instead focus on post-approval inspection.

There is no word in the Federal Register how an inspection could be conducted on an already implanted medical device or what the remedy would be if a design failure is determined post-market.

The agency says focusing on these activities would lead to fewer device failures, a decrease in device recalls, improved device innovation and efficiency and a streamlined inexpensive pathway to the market.

This is the latest example of FDA innovations that help device manufacturers get their devices to market faster under the “least burdensome” standard.

Upward of 95% of medical devices take the superhighway to the market through the FDA’s 510(k) clearance process (named for Section 510(k) of the Federal Food, Drug, and Cosmetic Act), after about 90 days, an exchange of paperwork, and a few thousand dollars.

That includes implantable medical device such as hernia mesh, transvaginal mesh, morcellator devices, hip implants, heart valve rings, and defibrillator leads, among other devices. See this Mesh News Desk story on medical devices that bypassed FDA scrutiny.

Patients and policymakers have long complained the clearance process does little to ensure medical devices are safe and effective.

Meanwhile the medical device industry complains that even the 510(k) is too burdensome and time-consuming and delays the launch of important new medical devices.

The 510 (K) process has long been scrutinized. In 2011 the Institute of Medicine called the clearance process “fatally flawed” and called for the outdated process to be abolished. ###

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