CIMIT: October 2009 Regulatory Affairs Newsletter

October 2009 Regulatory Affairs NewsletterPrint this page

FDA Looking at Clinicaltrials.gov Compliance. FDA officials are paying attention to whether device firms are complying with requirements for publicly registering and reporting clinical trial results. At a recent conference, staff noted that the agency will be mindful of industry confusion over what must be reported and which trials must be registered, but said FDA will not allow egregious noncompliance. While the agency cannot sanction manufacturers for certain actions until applicable regulations are issued in September 2010, FDA staff say they will contact companies and request a meeting if firms publish or post clinical trial results but do not appropriately register the trial and report the results on Clinicaltrials.gov. Additional information is available at www.thegraysheet.com (paid subscription service).

Participants in UDI Pilot Concerned About Feasibility. FDA recently conducted a pilot program to evaluate the feasibility of using a unique identifier system (“UDI”) for medical devices, and companies that participated in the pilot have expressed anxieties about the data required for such a system and the lack of clarity with respect to key requirements. The companies are concerned that firms would have to provide large amounts of data to FDA for a UDI system and note that some of these data may not be available in company records. Additionally, the companies identified a variety of standards and definitions that FDA must clarify in order for firms to participate in a UDI system. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Issues New CAD Guidance. On October 21, 2009, FDA published two new draft guidance documents related to computer-aided detection (“CAD”) devices, which use specialized software to identify abnormalities in radiology images or data. The first document addresses 510(k) submissions for CAD devices, while the second guidance document provides suggestions for conducting clinical trials of the devices. Comments on the draft guidance are due by January 19, 2009, but the agency is also holding a meeting of the Radiological Devices Panel on the topic, on November 18, 2009, at which comments may be delivered as well. Additional information is available at www.thegraysheet.com (paid subscription service).

Shuren Seeking to Lead CDRH Permanently. Dr. Jeffrey Shuren, Acting Director of the Center for Devices and Radiological Health (“CDRH”) at FDA, has announced that he would like to become the permanent head of the agency’s device center. Shuren, a neurologist and attorney, served in FDA Commissioner Margaret Hamburg’s office before being appointed interim director of CDRH in August. Comments from Principal Deputy FDA Commissioner Joshua Sharfstein indicate the Commissioner’s office strongly supports Shuren, though FDA is considering other candidates as well. Additional information is available at www.thegraysheet.com (paid subscription service).

Committee Calls for More Oversight of Genetic Tests. The Department of Health & Human Services (“HHS”) needs to close gaps in regulation of direct-to-consumer genetic tests, according to the HHS Secretary’s Advisory Committee on Genetics, Health, and Society. The Committee recently endorsed a series of recommendations for HHS to consider, including increasing FDA oversight of promotional claims made by makers of the tests. The Committee plans to issue further recommendations by the end of the year and likely will suggest that HHS draft a proposed rule to enhance regulation of the tests. Additional information is available at www.thegraysheet.com (paid subscription service).

Compliance Monitoring Likely on the Upswing at FDA. FDA is trying to address regulatory non-compliance more quickly and aggressively, according to Tim Ulatowski, director of the Office of Compliance at FDA’s Center for Devices and Radiological Health. At a recent conference, Ulatowski reported on current activities of the Office of Compliance, noting that the Office is focused on addressing import safety issues and ensuring that all device firms register and list their facilities, as required by FDA regulations. The Office will also issue a host of warning letters in the coming weeks, which Ulatowski said will be “a notable action.” Additional information is available at www.thegraysheet.com (paid subscription service).

Industry Group Refuses to Support Reduced Health Reform Fee. The Medical Device Manufacturers Association (“MDMA”) has said it will oppose any fee on the device industry that is included in health reform legislation, after a recent bill proposed a fee of $40 billion over ten years to help fund reform. Though device industry group AdvaMed is purportedly in negotiations with key legislators to reduce the device-industry fee to $10 or $20 billion over ten years, MDMA’s board voted unanimously to oppose even a reduced fee. MDMA claims that any such fee would stifle innovation and open the industry up to increased fees and taxes in future years. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Calls for Postmarket Data on Spinal Devices. FDA issued an order on October 5, 2009 requiring 12 manufacturers to collect postmarket data on dynamic stabilization pedicle screw systems cleared through the 510(k) process. The agency believes existing clinical data may not support the devices’ cleared indication of providing support and stabilizing the spine after spinal fusion surgery. FDA is concerned the devices, which seek to improve upon standard spinal screw and rod systems, could potentially loosen or break over time. In addition to the postmarket data, the agency is now requiring that new 510(k) submissions for these devices include clinical data. Additional information is available at www.thegraysheet.com (paid subscription service).

OIG to Investigate FDA Consumer Complaint Process. The Office of the Inspector General (“OIG”) at the Department of Health and Human Services will review FDA’s consumer complaint system in the upcoming year, according to a work plan issued on October 1, 2009. The consumer complaint system allows the public to notify FDA of product safety concerns and can be used to support product recalls or FDA investigations of a company. The OIG plans to issue a report by the end of 2010 assessing whether the agency records and investigates consumer complaints in a timely fashion. Additional information is available at www.thegraysheet.com (paid subscription service).

Amendments to Repeal Device Industry Fee Fail. Efforts to strike a $4 billion annual device industry fee from current health reform proposals failed to win approval of the Senate Finance Committee last week. The fee was included in a health reform bill proposed by Committee chair Sen. Max Baucus (D-Mont.), to aid in funding health reform. Committee members proposed amendments to either eliminate the fee or have the fee expire in 2019, but both amendments were voted down during the Committee markup of the bill. The device industry remains opposed to the fee, which would total $40 billion over 10 years, but congressional staff believe the fee is proportionate to fees on other industries, given device industry revenues in recent years. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA to Take Task Force’s Advice. FDA soon will begin incorporating recommendations from a Task Force charged with strengthening the 510(k) premarket notification program for marketing of medical devices, according to a September 25, 2009 memo from agency leadership. In the memo, Donna Bea Tillman, the director of the Office of Device Evaluation at the Center for Devices and Radiological Health, asked staff to notify her of any 510(k) proposing a new indication for use for a type of device. Additionally, she noted that FDA will be updating guidance regarding when companies should submit a new 510(k) for a modified device. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Adopts Risk Communication Plan. FDA has adopted a new strategic plan for communicating to the public information about risks associated with products regulated by the agency. The plan builds on the work of an FDA advisory committee that was convened in 2008 and 2009 to assess the agency’s risk communication practices. The plan outlines goals for the upcoming year, which include methods for researching ideal risk communication methods and creating an internal database of such methods. The agency also intends to post information regarding product recalls on the Web. Additional information is available at www.thegraysheet.com (paid subscription service).