Medical Devices Today

Home Use Of Devices Creates New Challenges For FDA, Manufacturers

The rapidly growing home health industry has raised new safety concerns about devices being used in the home setting and is leading FDA to reassess its regulatory oversight of such products, agency officials indicated at a meeting in Houston last week.

"Despite the fact that there is a lot of activity in this area and we've seen a lot of progress, I think we all want more devices that are designed and specifically tested for home use," Dan Schultz, director of CDRH said Sept. 17 at a meeting on home health care at the University of Houston.

"We want better and more consistent review criteria," he said.

CDRH's Home Health Care Committee hosted the Sept. 17-18 meeting in collaboration with the university to discuss with stakeholders the safety concerns that are surfacing as patients - and their devices - move out of the hospital and into the home (¹"The Gray Sheet" June 11, 2007, p. 5).

Congress Approves FDA Reform/User Fee Bill In The Nick Of Time

Congress gave final approval last week to a massive FDA bill that renews device and drug user fees for five years and strengthens product safety programs. Click here to read this complete article online at FDA Legislative Watch.

Global Harmonization Task Force Moves Into "Implementation Mode"

From the September 17, 2007, issue of "The Gray Sheet"

Efforts to harmonize device regulations globally will see more activity over the next year if Larry Kessler has his way.

Kessler, who is director of CDRH's Office of Science and Engineering Laboratories, is in a position to make it happen. In January, he was appointed to an 18-month post as chairman of the Global Harmonization Task Force.

Founded in 1992 by device regulators and industry reps from the United States, Canada, Europe, Japan and Australia to facilitate trade, GHTF has spent much of the past 15 years engaging in meetings and cyclical comment periods to build consensus on a collection of guidance documents.

CDRH Considers Internet Forum To Aid Device Safety Surveillance

From the September 10, 2007, issue of "The Gray Sheet"

FDA's device center is assessing whether an online forum for physicians can help with its postmarket surveillance challenges.

Sermo, which calls itself the nation's largest online physician community, said Sept. 5 that it has signed an "evaluation agreement" with CDRH, allowing the center to temporarily access its content.

The company will work with FDA "to explore opportunities and introduce new ways in which physicians can become efficiently involved in the surveillance of medical product safety," said Alex Frost, Sermo VP-research initiatives.

Preliminary Recs Would Stop Payments For Drug-Eluting Stents In Britain

From the September 3, 2007, issue of "The Gray Sheet"

A committee meets this week to consider whether to move forward with preliminary recommendations for the Nation Health Service of England and Wales to stop paying for drug-eluting stents.

Public comments on the recommendations were due Aug. 29 in the lead up to a National Institute of Health and Clinical Excellence (NICE) appraisal committee meeting on Sept. 4. This will be the fourth meeting by the committee on this topic in two years, but it is expected to submit its final appraisal to NICE in time for the institute to release final recommendations by January.

The $80-$100 million UK drug-eluting stent market is only a small piece of the $5.5-$6 billion worldwide market, but to the extent that an NHS decision could set a precedent for other European countries to follow, NICE's deliberations may have a larger impact on an already struggling sector.