CIMIT: June 2008 Regulatory Affairs Newsletter

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June 2008 Regulatory Affairs Newsletter

• Section 513(g) Filings Often Unnecessary
• Proposed Legislation will Seek to Overturn Supreme Court Decision
• FDA Cites Software Problems as Cause of Medical Device Malfunctions
• Synergo Combination Product Recommended for Approval
• HHS Amends Budget Request for FY 2009
• Recommendations for Gender-Specific Cardiovascular Studies Under Development
• FDA Staffer Stresses Link Between Human Factors and Adverse Events
• Congress Seeks to Delay Medicare DME Bidding Program
• FDA Considers 510(k) Status for Balloon Catheters
• Abiomed’s Impella 2.5 Receives 510(k) Clearance
• FDA Issues Digital Mammography Draft Guidance
• FDA Proposes Breast Cancer Patient Registry

Section 513(g) Filings Often Unnecessary
According to FDA, device firms should think twice before filing a device classification (“513(g)”) request with the agency. According to Heather Rosecrans, director of CDRH’s 510(k) staff who spoke at an FDA and Orange County Regulatory Affairs (“OCRA”) meeting in California in mid-June, 513(g) requests are non-binding, voluntary opinion letters from the agency that provide classification information about a specific medical device. Ms. Rosecrans made it clear that these letters are not a marketing authorization. Despite this, FDA has seen a steep increase in the number of 513(g)s filed in recent years. In fact, Ms. Rosecrans indicated that the agency received four 513(g) requests in 1990 and almost 400 in 2007. FDA believes that many of the recently filed 513(g)s are unnecessary. Accordingly, the agency is currently drafting two guidance documents to help clarify the role of 513(g)s. Additional information is available at www.thegraysheet.com (paid subscription service).

Proposed Legislation will Seek to Overturn Supreme Court Decision
Democratic legislators recently announced plans to introduce legislation in both houses of Congress that would overturn the Supreme Court’s decision in Reigel v. Medtronic, which protects manufacturers of FDA-approved medical devices from product liability lawsuits in state courts under certain conditions. According to lawmakers, the Supreme Court’s decision has denied victims any legal recourse against device manufacturers and has granted the blanket immunity for the life of their products. However, many in the medical device industry argue that the Court’s decision merely requires that FDA, not lay juries, should determine the safety and effectiveness of medical technology. Those opposed to the legislation claim that the bill will not improve patient protection, but will unnecessarily delay patient access to medical devices and will lead to higher health care costs. Additional information is available at www.medicalnewstoday.com.

FDA Cites Software Problems as Cause of Medical Device Malfunctions
In 2004, FDA established a forensic software department made up of mathematicians, computer scientists, and physicists who address medical device recalls related to software problems. The department recently announced that many device malfunctions are not the result of poor design, but are caused by errors in the software that controls the device. Last year, 23 of the life-threatening medical device recalls involved software problems. With the development of software that essentially replaces human intervention with devices, FDA’s tolerance for mistakes in software code is decreasing. Additional information is available at www.medicalnewstoday.com.

Synergo Combination Product Recommended for Approval
On June 25, 2008, FDA’s Gastroenterology and Urology Devices Panel unanimously recommended Medical Enterprises’ Synergo combination product for approval. The Synergo is intended to prevent bladder cancer recurrence after surgical removal of superficial tumors in patients with an intermediate risk of cancer recurrence. The product uses a radiofrequency antenna incorporated into a transurethral catheter to heat the bladder wall, while the chemotherapy agent mitomycin C is simultaneously circulated in the bladder. The penetration of the drug appears to be increased by the heat produced by the device. CDRH has been granted primary jurisdiction to regulate Synergo. Additional information is available at www.thegraysheet.com (paid subscription service).

HHS Amends Budget Request for FY 2009
On June 9, 2008, Health and Human Services ("HHS") Secretary Leavitt announced that the Administration is amending its fiscal year ("FY") 2009 budget request to include an additional $275 million for FDA. Secretary Leavitt called upon Congress to move quickly on this request and other pending Administrative legislation proposals that would strengthen FDA. This action supports FDA's current strategy to adapt to the demands of the global economy. Under the proposed budget amendment, FDA will be given the resources to improve import safety by establishing a presence in several regions around the world and by modernizing its information technology systems, among other things. Additional information is available at www.fda.gov.

Recommendations for Gender-Specific Cardiovascular Studies Under Development
FDA is working to develop recommendations for the inclusion of gender-specific device performance information in premarket applications and medical device labeling. These recommendations come in response to the historical underrepresentation of women in cardiovascular trials, barriers to enrolling women in such trials, and poorly designed trials that do not account for the unique characteristics of women. Based on a June 2, 2008, workshop discussing these issues, FDA concludes that further research is needed to define the appropriate number of women needed for individual product trials. The agency is motivated to address the underrepresentation of women in cardiovascular trials and expects to develop future guidance based on the June 2 meeting, as well as other information gathering efforts. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Staffer Stresses Link Between Human Factors and Adverse Events
According to a recently published article by Suzanne Rich, a senior project manager at CDRH, many medical device adverse events are caused by a poorly designed interface between the device and the user. Human factors, the science that focuses on understanding how people interact with technology, can be the key to a successful device design that minimizes adverse events. Using human factors science, manufacturers can effectively design devices according to the users' needs, abilities, limitations, and work environments. Manufacturers should consider three major areas when evaluating device-related adverse events from a human factors perspective: user characteristics, device design considerations, and the environment in which the device is used. Additional information is available at www.fda.gov.

Congress Seeks to Delay Medicare DME Bidding Program
On June 6, 2008, Senators Stabenow (D-Mich.) and Voinovich (R-Ohio) circulated a letter in the Senate seeking support for legislation to delay the Medicare competitive bidding program for durable medical equipment ("DME"), which is scheduled to begin on July 1, 2008. The program has been heavily criticized, in part because more than half of the suppliers who placed bids were disqualified because they were missing paperwork. The letter, which was signed by 132 lawmakers, calls for legislation that would delay the program by at least one year. Additional information is available at www.medicalnewstoday.com.

FDA Considers 510(k) Status for Balloon Catheters
On May 30, 2008, FDA issued a Federal Register Notice requesting comments regarding whether balloon-tipped percutaneous transluminal coronary angioplasty catheters should be moved from Class III to Class II. This shift would allow many balloon catheters to enter the U.S. market through the premarket notification (“510(k)”) pathway, rather than the more onerous premarket approval (“PMA”) pathway. Although FDA’s “tentative” preliminary assessment suggests such a move, the agency stressed that more complex balloon catheters, such as those with plaque-cutting or scoring elements, will remain Class III devices subject to PMA. FDA also released a draft guidance outlining special controls that catheters would be subject to under the proposed reclassification. Public comments are due to FDA by August 29, 2008, and can be submitted online at www.regulations.gov. Additional information is available at www.thegraysheet.com (paid subscription service).

Abiomed’s Impella 2.5 Receives 510(k) Clearance
On June 2, 2008, Abiomed, Inc., announced that FDA has cleared its Impella 2.5 Cardiac Assist Device through the premarket notification (“510(k)”) pathway. According to the company, this device could change the standard of care in the catheterization laboratory (“cath lab”) because it provides immediate, minimally invasive circulatory support for critical patients. The Impella 2.5 is cleared for use for partial circulatory support for periods up to six hours. Additional information is available at www.fdanews.com or www.devicelink.com.

FDA Issues Digital Mammography Draft Guidance
In the May 30, 2008, Federal Register Notice, FDA announced a proposed rule to reclassify full field digital mammography (“FFDM”) systems from Class III to Class II devices, subject to special controls. The agency also announced the availability of its draft guidance entitled Class II Special Controls Guidance Document: Full Field Digital Mammography System. The guidance explains the agency’s requirements for FFDM compliance with special controls for Class II devices. Public comments must be received by FDA by August 28, 2008, and can be submitted electronically at www.regulations.gov. Additional information is available at www.fda.gov.

FDA Proposes Breast Cancer Patient Registry
FDA has proposed the development of a patient registry to help device firms design better clinical trials to evaluate the use of thermal ablation as an alternative to more invasive surgery for treating breast cancer. FDA has requested comments regarding whether the new registry could facilitate the standardization of breast cancer trials across treatment alternatives. The agency is also planning to hold a workshop later in the year to evaluate the clinical trial issues that should be considered when studying thermal ablation devices for breast cancer treatment. Additional information is available at www.thegraysheet.com (paid subscription service).