FDA meeting over uterine surgical device and cancer risk sparks debate | Regulatory news for the week of July 14, 2014

Debate heats up during FDA meeting over uterine surgical device and cancer risk

July 11, 2014 by Ingrid Mezo

Scores of speakers expressed outrage before a panel of FDA experts gathered at a public meeting yesterday and today to discuss the future of laparoscopic power morcellators (LPMs), devices used to break up and extract tissue during minimally invasive gynecologic surgeries.

The devices have been the subject of controversy and lawsuits over concerns that they may cause the spread of undetected cancers by disseminating cancerous tissue when used to break up and remove what are thought to be benign growths in the uterus. This can cause the “upstaging” of a cancerous growth that could have been removed through an abdominal surgery to a fatal stage IV cancer. Read more

Merit Medical wins China OK for Aero device

July 9, 2014 by Brad Perriello

Merit Medical said today that its Endotek division will make a 1st foray into the Chinese medical device market, after regulators there approved its Aero tracheobronchial stent.

South Jordan, Utah-based Merit said the Chinese Food & Drug Administration granted a 5-year approval for the Aero system, including its over-the-wire deployment and direct visualization systems. Read more

Back in the USA: Cook Medical's Evolution lead extraction device returns

July 10, 2014 by Brad Perriello

Cook Medical said today that it’s Evolution RL and Evolution Shortie RL cardiac lead extraction devices are back on the U.S. market after a 2-month suspension prompted by an FDA warning issued last April.

The FDA had accused the Bloomington, Ind.-based medical device company of selling an unapproved device in the U.S., saying changes made to the Evolution devices required Cook Vascular to file a new clearance application with the federal watchdog agency. Read more

FDA flags Zynex Medical over chronic pain devices

July 9, 2014 by Brad Perriello

The FDA sent a warning letter last month to Zynex Medical flagging problems with how it handles adverse events with its NexWave and IF8000 chronic pain devices.

The federal watchdog agency said inspections conducted at Zynex’s Lone Tree, Colo., plant found that the company failed to establish adequate procedures for design inputs; failed to establish procedures for design verification; failed to establish a device master record; failed to maintain device history records with all the information required; failed to establish procedures for corrective and preventive actions and failed to establish procedures for internal audits, according to the June 27 letter. Read more

FDA offers new guidance on 510(k) risk/benefit review

July 14, 2014 by Arezu Sarvestani

Federal medical device regulators issued new draft guidance this week hoping to clarify the agency’s process for determining the benefits and risks of 510(k) devices.

The new guidance wouldn’t change any of the FDA’s existing policies for evaluating 510(k) submissions, but the agency hopes the document will help device makers better understand the agency’s thinking. Read more