Medical Devices Today

CDRH Explores Recommendations For Gender-Specific Cardiovascular Studies

Full article reprinted from "The Gray Sheet" - June 9, 2008

FDA's device center is developing recommendations for industry on the inclusion of gender-specific device performance information in pre-market applications and device labeling.

Regulatory Experts Note Wrinkles In FDA Accepting ISO 13485 Quality Audits

Why are FDA insiders skeptical about the idea of having a resource-starved FDA use internationally-accepted ISO 13485 audit reports in place of its own foreign facility inspections?

Medtronic Exec Will Bring Device Perspective To Clinical Trials Coalition

Full article reprinted from "The Gray Sheet," May 19, 2008

With a broad-based and seasoned executive board in place, the recently formed FDA/Duke University partnership aimed at improving clinical trials is gaining momentum and seeking to fill out its ranks.

On May 12, "The Gray Sheet" touched base with Clinical Trials Transformation Initiative (CTTI) executive board member Susan Alpert, chief quality and regulatory officer at Medtronic. Prior to overseeing all of Medtronic's quality, regulatory and clinical compliance efforts, Alpert held several positions at FDA in the centers for drugs and devices, including a six-year stint as the director of the Office of Device Evaluation.

The lone device industry rep on the group's executive board, Alpert said she will make it her priority to bring device-specific issues to the group's attention.

Legal Issues Abound For Device Marketers In The Blogosphere

This article is reprinted from "The Gray Sheet" – May 12, 2008

Tapping into the blogosphere could give medical device companies unprecedented access to patient and physician customers, but using blogs for marketing purposes carries a raft of legal responsibilities as well.

"You can be very cavalier about this venue, and shouldn't be," Mark DuVal, who specializes in drug and device law at DuVal and Associates in Minneapolis, told "The Gray Sheet." "From a legal, regulatory standpoint, it can be kind of a minefield."

The potential legal danger zone encompasses not only blogs, but also social networking sites, message boards and other types of interactive, so-called "new media."

Neither FDA nor the Federal Trade Commission, the main regulators of device advertising and promotion, have developed specific guidance on manufacturer use of new media, though both say blogs and other sites fall within their increasing scrutiny of Internet marketing.

GMP Inspection Results Can No Longer Stay Within Borders, Says FDA

This article is reprinted from "The Gray Sheet" – March 31, 2008

Results from manufacturing facility inspections conducted in one country will easily be shared with regulators in another in the near term, says Larry Kessler, FDA officer and chair of the Global Harmonization Task Force.

"We are now setting up electronic systems to share regulatory auditing information around the world," Kessler, also the director of FDA's Office of Science and Engineering Laboratories within CDRH, said March 27 at a meeting of device industry stakeholders at Harvard University.

The new systems are being developed as part of the GHTF National Competent Authority Report exchange program, he said at the annual Medical Device Regulatory, Reimbursement and Compliance Congress.

The exchange program, in which countries such as China have pledged to participate, is already up and running for sharing among national authorities adverse event reports and information on device returns, modifications and destruction (¹"The Gray Sheet" Aug. 22, 2005, p. 19).

Radio Interference? FDA Studies Potential RFID Impact On Implantables

Radiofrequency fields are becoming more prevalent in hospitals and other public spaces as a tracking identification tool, but government scientists worry the energy waves could impact the performance of implantable devices such as pacemakers and defibrillators.

Little is know about how radiofrequency identification (RFID) systems may interfere with pacemaker and implantable cardioverter defibrillator (ICD) performance, so FDA researchers, implantable cardiac device makers and RFID system manufacturers have begun to investigate the issue.

Engineers at CDRH's electromagnetic and wireless technology lab at the new White Oak facility in Silver Spring, Md., are testing pacemakers and ICDs from five major cardiac implant manufacturers using seven different RFID readers.

Seth Seidman, an electrical engineer at the agency's Office of Science and Engineering Laboratories (OSEL) who is leading the project, says FDA receives numerous incident reports related to electromagnetic interference from cell phones, anti-theft systems and metal detectors, but the RFID issue is "pretty new."

Combo Products Offer Ambiguity For Product Liability Pre-emption

This article is reprinted from "The Gray Sheet" – March 17, 2008

Plaintiffs lawyers are trying to leverage the ambiguous status of combination products as an exception to a Feb. 20 U.S. Supreme Court decision that affirms significant protections for the device industry from personal injury lawsuits.

Steven Angstreich, a trial lawyer with Levy, Angstreich, Finney, Baldante, Rubenstein & Coren in Philadelphia, argues that drug-device products should not be entitled to federal pre-emption under the Food Drug and Cosmetic Act (FDCA).

Stuart Gerson, an attorney with Epstein, Becker & Green who represents pharmaceutical and device companies, agrees that combination products are not a settled matter when it comes to liability protections. "There is plenty of room yet to wiggle and combination products provide that wiggle room," he said.

Angstreich is a lead plaintiffs' counsel in ongoing multidistrict litigation against St. Jude Medical arising from a 2000 recall of the company's Silzone-coated mechanical heart valves. He also represents plaintiffs suing Medtronic following the October 2007 recall of its Sprint Fidelis ICD leads.

Patients Deserve More Information On Potentially Faulty Devices – Maisel

A leading expert on medical device safety wants Congress to compel FDA and manufacturers to provide more consumer protections for patients with implanted devices.

"The welfare of medical device recipients must become a higher priority for the FDA and manufacturers, and it is increasingly apparent that such a change will require Congressional action," William Maisel, M.D., argues in an editorial in the March 6 New England Journal of Medicine.

Maisel is the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center and a faculty member at Harvard Medical School. He has published several studies on device safety and physicians' responses to FDA recalls. Maisel is also a past chairman of FDA's Circulatory System Devices advisory panel and currently serves on CMS' Medicare Evidence Development and Coverage Advisory Committee.

"Remarkably, we have consumer protections for airline passengers, cable-television customers, and cellular-telephone users, but few for patients who receive life-sustaining medical devices," Maisel observes. "Only with well-defined, specific consumer protections for such patients can we hope to minimize adverse health consequences and avoid costly recalls."

FDA Is Crystallizing Standard Template For Press Releases On Recalls

FDA is proposing a new template for all product recalls, from medical devices to pet food, that seeks to have firms put recalls into the proper context. It also offers them some flexibility in wording the announcements made in response to safety reports.

The agency's Office of Regulatory Affairs presented FDA's Risk Communication Advisory Committee with a model of the proposed template, which the agency has been developing for several months.

An internal working group will take the committee's suggestions into consideration as it finalizes the form, said David Elder, director of ORA's Office of Enforcement, at the inaugural committee meeting, held Feb. 28-29 in Gaithersburg, Md.

FDA sought advice from the committee on the structure and content of the template, whether it will actually reduce risks to patients and whether standardization is appropriate across all FDA products.

Industry Looks To FDA’s New Combo Products Chief For Answers

FDA's Office of Combination Products says it is getting back on track with new leadership in place after months of flux. Industry meanwhile is pushing the office to accelerate the release of rules and guidelines to help companies navigate the relatively new area of regulation.

Thinh Nguyen, who took over as director of the office Jan. 6, says his 14 years of experience at CDRH, where he was a key player in the premarket review office, will serve him well at OCP. "Most of the combination products have a device component," he said in a Feb. 13 interview with "The Gray Sheet."

Nguyen says he will work to "bridge the gaps" between different parts of the industry developing combination products. He will largely pick up where former director Mark Kramer left off on several key issues, he says. Kramer headed the office since it was formed by the 2002 device user fee legislation and departed for the private sector in April 2007.