Weekly Device Summaries for July 26-30, 2010

Industry Opposes Plan to Publicize Pre-Market Information.  In comments to the agency, the drug and device industry expressed strong opposition to FDA’s proposal to make public certain information before a drug or device has been marketed.  In a series of proposals issued in May, FDA suggested disclosing when firms submit clinical trial applications or marketing applications, as well as FDA actions on such applications.  The drug and device industry commented on these proposals, noting that such disclosure would eliminate competitive advantages, putting small companies and innovation at risk.  FDA is considering the comments and then will decide whether to implement the proposals.  

Workshop Addresses Regulation of Lab-Developed Tests.  FDA held a two day workshop last week to discuss a regulatory scheme for laboratory-developed tests.  The tests have previously not been regulated by FDA, though the agency has always contended that it has the authority to do so.  Recently, FDA has expressed an intent to exercise oversight of the tests and held the workshop to gather public and stakeholder input on the issue.  Agency staff said at the workshop that FDA will pursue a risk-based scheme for regulating the tests, but workshop attendees noted that determining which tests are high-risk and which are low-risk will be difficult.  

FDA Retracts Pediatric Data Rule.  After considerable opposition, FDA has withdrawn a direct-to-final rule that would have required industry to submit data to the agency about pediatric use of their devices. The rule would have required device firms to provide, in premarket submissions, data on pediatric populations suffering from the disease targeted by the device. The rule was published in April and scheduled to take effect in August, but FDA received numerous comments from industry, contending that the agency was overstepping its authority.  FDA will now consider the April rule merely a proposed rule which, after receiving public comments, the agency will finalize in the near future. 

Weekly Device Summaries for July 19 -23, 2010

Preventive Screenings May Increase Due to Health Reform.  Utilization of preventive services, including screening tests, may increase under new regulations issued this month by the Department of Health and Human Services.  The regulations implement provisions of the health reform law, which require insurance companies to cover certain preventive services without a co-pay or deductible contribution from the patient.  As a result of the regulations, more patients may seek to undergo screening tests such as colonoscopies or mammograms, as well as routine tests for diabetes, cholesterol levels, and blood pressure.

FDA Developing Luer Lock Standard.  In a recent letter to device manufacturers and hospitals, FDA said the agency is aiding in the development of an international standard for luer lock connectors.  According to FDA, the connectors—which link together medical products such as intravenous (“IV”) tubing and bags of IV solution—can cause serious injury or death if used incorrectly.  Specifically, similar-looking connectors have been used to link two mismatched items, such as a feeding tube and an IV solution.  If FDA decides to adopt the standard once finalized, the agency will issue guidance to aid manufacturers in complying with the standard. 

FDA and CMS Publish Data-Sharing Memo.  Recently, FDA and the Centers for Medicare and Medicaid Services (“CMS”) signed a memorandum in which the two agencies agree to share data related to marketing and reimbursement reviews of medical devices.  The memo, which is the first step toward parallel review of new devices by the two agencies, was released to the public last week.  In the memo, the agencies agree to protect trade secrets and confidential commercial information, an issue of concern to the device industry.  Additionally, the agencies agree to hold a meeting within a month to discuss procedures for implementing the memo.

Weekly Device Summaries for July 12 -16, 2010

FDA Grappling with Regulation of Cytogenetic Tests.  FDA is seeking to regulate cytogenetic tests, which are used to detect changes in the number of a person’s genomic copies, potentially predicting diseases or genetic disorders.  The agency held a workshop on June 30, 2010 to seek feedback on the optimal oversight for the tests, which have previously not been regulated by FDA.  To date, the tests have mostly been used for laboratory research, but FDA noted at the meeting that device firms have expressed interest in bringing cytogenetic tests to market.  As a result, FDA is struggling to develop a regulatory strategy for the tests, which yield a large amount of genetic data and results that may be difficult to interpret.

Industry Weighs in on Home-Use Device Initiative.  In April, FDA introduced an initiative aimed at improving the safety of medical devices intended for use in the home.  Recently, the device industry submitted comments on the initiative, recommending that FDA rely on existing standards to avoid creating new, conflicting requirements for home-use devices.  Specifically, industry trade group AdvaMed suggested that FDA officially recognize an existing international standard for home-use devices, noting that it addresses the unique challenges raised by home use.  Individual device firms supported AdvaMed’s proposal, commenting that the standard also addresses user error and other human factors that can affect home use of devices.

FDA Reaches Out to Diabetes Test Makers.  FDA has issued a letter to firms that make hemoglobin A1c (HbA1c) assays, encouraging companies to meet with FDA to discuss marketing their tests for diabetes diagnosis.  Currently, HbA1c tests are only cleared for monitoring glucose control in diabetic patients, but recent guidelines from the American Diabetes Association indicate the tests can also be used to diagnose the disease.  Though FDA notes in its letter that a new clearance would be needed before existing tests could be marketed for this use, the agency encouraged dialogue on the issue.  Additional information is available at www.thegraysheet.com (paid subscription service) and http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm218389.htm.

Weekly Device Summaries for July 5 -9, 2010

Government Explores Ways to Speed Innovation.  A new government initiative seeking to encourage development of innovative medical devices held its first meeting on June 24, 2010.  The Council on Medical Device Innovation includes representatives from several government agencies, including FDA, the Department of Defense, and the Centers for Medicare and Medicaid Services (“CMS”).  At the meeting, the Council discussed ways in which government agencies could collaborate to facilitate development of devices for unmet public health needs.  One suggestion involved Medicare reimbursement for devices currently under review by both FDA and CMS.  A second idea involved limited approval of new devices for use in military hospitals, prior to full marketing approval from FDA.

Industry Requests Reform of Humanitarian Device Program.  Improved incentives are needed for firms to develop devices for rare diseases, according to industry speakers at a recent hearing.  Currently, such devices can be marketed under FDA’s Humanitarian Device Exemption (“HDE”) program, but industry groups say that reforms are needed to make the program more attractive to device firms.  Specifically, tax credits and a period of market exclusivity for HDE devices could entice companies to invest in HDE devices.  Additionally, flexibility on the part of FDA’s data requirements for the devices would provide an added incentive. 

Court Ruling Applauded by Diagnostic Firms.  On June 28, 2010, the Supreme Court ruled that a strict test should not be the sole criterion for determining patent eligibility for certain innovative processes.  The ruling was lauded by makers of diagnostic tests, who feared that the test, if allowed to stand, would preclude patenting of certain processes used in diagnostic medicine.  The Court did not provide guidance, however, as to what other thresholds may need to be met for a process to be patentable.  Instead, the Court indicated that the lower court responsible for reviewing patent cases should develop guidelines on the patentability of process claims.

Additional information on these topics is available at www.thegraysheet.com (paid subscription service).