Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 02 May 2017 | By Zachary Brennan
The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites.
The committee discussed the bills with various experts and Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who offered no opposition to any of the measures and reinforced the criticality of reauthorizing the Medical Device User Fee Amendments in a timely manner.
On one of the four measures, to create a market where hearing aids can be sold over the counter (OTC), Shuren noted that currently, 80% of those who would benefit from a hearing aid never get one and an OTC marketplace might improve the situation.
With the advent of newer, self-fitting and self-programmable hearing aids, Shuren also said consumers will benefit from better self-tailoring. Representatives and senators from both sides of the aisle offered support for the OTC hearing aid bill.
Another one of the bills would revamp FDA’s medical device inspection processes, which some complain create an uneven playing field for domestic and foreign device manufacturers as the foreign inspections are often shorter.
Shuren noted that domestic inspections might take longer than foreign ones because inspectors may be called on to inspect a for-cause site as they are inspecting another site domestically, whereas with foreign sites, the inspectors usually enter the country, perform the inspection and then leave.
He also noted the upcoming realignment of FDA’s Office of Regulatory Affairs, which he said should further reduce the amount of time it takes for domestic inspections.
A third bill discussed on Tuesday would authorize FDA, under certain conditions, to approve or clear an imaging device or an imaging device enhancement for use with a contrast agent in a new indication that is not among the approved indications of the contrast agent.
This would be a departure from what FDA does currently as the agency cannot approve or clear imaging devices for use with currently approved contrast agents if the contrast agents are not also labeled for that use.
Joe Robinson, SVP of Philips North America, speaking on behalf of the Medical Imaging and Technology Alliance, told the committee: “Since a contrast agent manufacturer often has no need or incentive to revise the labeling, updates to contrast agent labeling are not keeping pace with the technological advancements of medical imaging devices, and such advancements are not being approved or cleared by FDA.”
The fourth bill, meanwhile, would require third-party device servicing organizations to register with FDA, maintain an internal complaint handling system and file adverse event reports, among other provisions.
Patricia Shrader, VP of global regulatory affairs at Medtronic, speaking on behalf of industry group AdvaMed, told the committee: “Requiring third-party servicers to register with the FDA is an important common sense, first step in assuring that patient safety is not put at risk by well-intentioned but poorly-carried out repairs or substandard or inappropriate parts.”
But Robert Kerwin, general counsel of the International Association of Medical Equipment Remarketers and Servicers, said his association opposes the legislation, saying it’s a solution for an unidentified problem.
H.R. 1652, the Over-the-Counter Hearing Aid Act of 2017
H.R. 1736, to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications
H.R. 2009, Fostering Innovation in Medical Imaging Act
H.R. 2118, Medical Device Servicing and Accountability Act
Tags: medical device inspections, FDA inspections, hearing aids, OTC hearing aids, MITA, AdvaMed, contrast agents