Vaginal Mesh problems are going to land at someone’s door and J&J’s looking like a soft target. It transpires the company decided to launch “Prolift” in 2005 as an “insignificant change” to a previous device, so didn’t feel the need to tell FDA about it.
Regulatory
Is FDA About To Clip Stryker’s Wingspan?
Stryker’s Wingspan Stent is up for FDA panel review on March 23rd. FDA’s Executive Summary, released today doesn’t auger well as results of clinical study don’t seem to support safety and efficacy claims.
MHRA Comes Out Fighting
Dost thou think the agency protests too much? MHRA adopts a defensive stance against sniping media.
Do New EU Rules On Electronic Instructions For Use Go Far Enough?
Bravo European Commission for allowing electronic Instructions For Use, but we think you could have gone a bit further.
View from the Med Week 10 Now Available. Enjoy the Read
Regulatory approvals, mergers and acquisitions, meetings and congresses… and even a bit of telehealth. Quelle Surprise!
All-Metal Hips: Media Coverage Won’t Necessarily Aid Regulatory Reform
Did you hear the one about the company that thought it had a winner on its hands by developing its own version of an increasingly popular type of hip replacement?
PIP Should Not Provoke Knee-Jerk Reforms Says MHRA Chief
“To devise a regulatory system solely about this particular event would be to miss the point that most of the … continue reading “PIP Should Not Provoke Knee-Jerk Reforms Says MHRA Chief”
FDA Slow To Clear Products When EU Data Lacking
New paper compares CE vs FDA and concludes both need a makeover.
Health Commission Urges Tighter EU Regulatory Controls Following PIP
Should European Union member states take immediate steps to tighten regulatory controls over medical devices and technologies in the wake of the PIP scandal?
Ex-Eucomed Boss Is New Director Of Medical Devices At MHRA.
At a time when MHRA has never been higher profile, it gets a new boss.
PIP Scandal: Spot Checks On The Agenda
Lack of unnannounced Spot check provision in Medical Devices Directive seems like and easy fix.
PIP: MHRA Raises Questions About Responsibility Of “Member States”
MHRA counters Financial Times article and “raises questions” about the responsibility of “member states”.
PIP: French Authorities Agree With Medlatest On Spot Checks.
Unannounced spot checks would have given Notified bodies a chance of preventing the PIP scandal. Now French competent authority AFSSAPS signs up to the notion.
UK MHRA Responds To Lancet Article
MHRA comes out fighting “misleading” Lancet
PIP: A Vision Of The Future? Really?
In this editorial we ask whether it’s joined up thinking to claim that the PIP situation, just because it’s a private sector issue, means all private healthcare will be riddled with problems and providers not willing to cooperate on their solution?
Eucomed Weighs In With Statement On PIP
In a strongly worded press release issued on 9th January, relating to the ongoing scandal relating to PIP breast implants, European medtech industry body Eucomed seeks to make its position clear.