CIMIT: July 2008 Regulatory Affairs Newsletter

THIS PAGE HAS BEEN FORMATTED FOR EASY PRINTING

July 2008 Regulatory Affairs Newsletter

• CMS Gains Ability to Cover Preventive Services
• FDA Launches Two-Year Fellowship Program
• NICE Appeal Panel Denies Cordis Appeal
• Chinese Government Focuses on Corruption in Medical Device Sales
• CDRH Matrix Postmarket Safety Organization Launches
• FDA Considers Revisions to Quality System Regulation
• FDA Increases Software Forensics Capabilities
• Artificial Disk Trials Challenge Manufacturers
• Intel Gains 510(k) Clearance for Remote Care and Monitoring Device
• FDA Warns Against Possible Device Malfunctions
• India to Create Medical Device Regulatory Body
• Durable Medical Equipment Legislation Goes to President

CMS Gains Ability to Cover Preventive Services
The recently passed Medicare Improvements for Patients and Providers Act (“MIPPA”) allows the Centers for Medicare and Medicaid Services (“CMS”) to use the national coverage determination (“NCD”) process to provide coverage for preventive medical services that are endorsed by the U.S. Preventive Services Task Force. Prior to enactment of MIPPA, the agency could only cover services that treat or diagnose a disease—not preventive services. However, Congress has enabled coverage of a limited number of preventive services over the years, such as a one time screening for abdominal aortic aneurysms, mammograms, and screenings for diabetes, colorectal cancer, and osteoporosis. Under MIPPA, CMS is granted the authority to take the relationship between predicted outcomes and the expenditures for such services into account when making coverage decisions. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Launches Two-Year Fellowship Program
FDA is launching a new two-year fellowship program to attract more scientific talent to the agency. The program is designed to train scientists and engineers on the scientific foundations of its regulatory decisions. The program, which beings this October, will employ 30–40 fellows. To qualify, applicants must have a doctoral degree in medicine or another scientific field or at least a bachelor’s degree for engineering positions. Additional information is available at www.fdanews.com.

NICE Appeal Panel Denies Cordis Appeal
In its July 23, 2008, decision, an appeal panel for the United Kingdom’s National Institute for Health and Clinical Excellence (“NICE”) denied Johnson & Johnson/Cordis’ appeal of the agency’s recommendation that the National Health Service cover drug-eluting coronary stents only if the device costs no more than £300 (approximately $597) more than a bare metal stent. The appeal panel concluded that the recommendation does not exceed NICE’s legal power nor does it violate the agency’s established procedures. In addition, the panel believes that the recommendation is consistent with currently available scientific evidence. Additional information is available at www.thegraysheet.com (paid subscription service).

Chinese Government Focuses on Corruption in Medical Device Sales
In late March of this year, the Chinese Premiere held a special meeting with his cabinet to discuss anti-corruption work by the State Council in China. In this meeting, the Premiere identified areas of known corruption, pinpointing specific industries including medicine and medical device sales. These industries are believed to be particularly susceptible to corruption because abuse of power and ineffective oversight remain constant in those fields. The focus of the Chinese government on corruption should be a signal to medical device companies doing business there to redouble their compliance efforts. Additional information is available at www.thegraysheet.com (paid subscription service).

CDRH Matrix Postmarket Safety Organization Launches
On July 14, 2008, CDRH launched its new cross-center postmarket safety “matrix” organization. The matrix is a part of CDRH’s ongoing postmarket transformation initiative, which includes other efforts, such as unique device identification, electronic Medical Device Reporting, and risk-communication strategies. The matrix reports directly to the Office of the Center Director and is divided into 13 product and issue groups, including orthopedics, plastic surgery, science, and regulatory and special interests, among others. The group will be reviewing new safety information and bringing together relevant staff involved in premarket review, analysis of adverse events, research, and other areas. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Considers Revisions to Quality System Regulation
FDA may soon be updating and improving the Quality System regulation (“QSR”) to be more in line with international standards regarding the use of consumer feedback to enhance quality systems. According to Timothy Ulatowski, director of CDRH’s Office of Compliance, one key difference between the QSR and the international standard—ISO 13485—is the idea of continuous improvement and customer satisfaction. FDA is considering the options of either reforming the QSR or simply adopting the international standard. In addition, the agency is evaluating whether to accept ISO 13485 quality system audit reports in place of FDA inspections of foreign device firms. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Increases Software Forensics Capabilities
According to industry insiders, FDA appears to be increasing its software forensics capabilities with the use of static analysis tools. In light of this, device manufacturers should increase their efforts for quality assurance in software engineering. Experts agree that good software engineering, including design controls, risk analysis, and a quality system, as well as proper tools and techniques, is important to reducing software errors. However, the implementation of static analysis programs is costly, which may be a problem for small device firms. Additional information is available at www.medicaldevicelink.com (paid subscription service).

Artificial Disk Trials Challenge Manufacturers
Artificial disc manufacturers face numerous challenges in the conduct of pivotal trials, especially as more and more of these products enter the marketplace. According to FDA’s April 2008 guidance document, Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs, such trials should be multi-center, randomized, controlled studies. However, it is becoming increasingly difficult to find patients willing to participate in pivotal trials as more patients learn about treatment alternatives, including currently available artificial discs and spinal fusion. Sponsors are encouraged to consider their future reimbursement strategy in the design of pivotal trials, since many payers currently refuse to cover these devices without sufficient long-term data. Long-term outcomes, functional, and economic endpoints in pivotal trials may help sponsors make a case for reimbursement. Additional information is available at www.thegraysheet.com (paid subscription service).

Intel Gains 510(k) Clearance for Remote Care and Monitoring Device
Intel Corporation recently announced that it has obtained 510(k) clearance of its Health Guide PHS6000, a laptop-like device that allows patients with chronic conditions to be monitored remotely. The device also facilitates the exchange of information between patients and their healthcare providers, without need for the patient to visit the hospital or clinic. The device has an interface that allows it to connect to a number of other home medical devices so that clinicians can monitor patients remotely. The patient’s information is uploaded to a secure host server, where it can be accessed by the health care professional. The device is expected to be available on the U.S. market at the end of 2008 or early 2009. Additional information is available at www.medicalnewstoday.com.

FDA Warns Against Possible Device Malfunctions
On July 14, 2008, FDA released a preliminary public health notification to alert the public to the possibility that certain CT scans may cause some electronic medical devices to malfunction. Although most patients with electronic medical devices experience no adverse consequences from CT scans, the agency has received a small number of adverse event reports in which the scans may have interfered with electronic medical devices. Specifically, FDA cites pacemakers, defibrillators, neurostimulators, and drug infusion pumps among the medical devices that may be affected. FDA intends to continue to investigate these events and has stressed that no patient deaths have occurred from CT scanning of electronic medical devices. Additional information is available at www.fda.gov.

India to Create Medical Device Regulatory Body
The Indian government has decided to work with industry to develop a new medical device regulatory body in response to a 2006 mandate to register certain devices. But, until India’s device agency is fully functional, most of the country’s device policy will continue to come from its pharmaceuticals body. The new device agency’s initial structure could be in place as early as the end of 2008 and will likely harmonize its policy with world standards. Industry groups have stressed that the new medical device regulations should be transparent, predictable, based on risk management and good governance principles, and should utilize standards adopted by the Global Harmonization Task Force. Additional information is available at www.medicaldevicestoday.com.

Durable Medical Equipment Legislation Goes to President. On July 9, 2008, the Senate passed a bill that will delay the Medicare competitive bidding program for durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”). The legislation, entitled the Medicare Improvements for Patients and Providers Act, was also passed by the House of Representatives last month and is now on its way to the President’s desk for signature or veto. The legislation will delay implementation of the first round of the competitive bidding program and will terminate any contracts already awarded under the program. Such delay will be funded by a two percent reduction in Medicare payment rates for DMEPOS. President Bush has threatened to veto the legislation, but the margins by which it passed both the House and Senate are enough to override a presidential veto. Additional information is available at www.fdanews.com or www.thegraysheet.com (paid subscription service).