Medical Device Link.

In April, the Association of Medical Diagnostic Manufacturers (AMDM; Washington, DC) held its 36th annual meeting in North Bethesda, MD. The two-day meeting covered various topics related to current issues affecting the IVD industry. Such topics included discussions on compliance, quality systems, new guidance documents, evolving trends, legislative and regulatory actions, and international regulatory requirements.

One of the speakers at the meeting, Richard Naples, vice president, corporate regulatory affairs at Becton, Dickinson and Co. (Franklin Lakes, NJ), gave a presentation on “Legislative and Policy Landscape under the New Congress and New Administration: What Does This Mean for FDA/OIVD.” He discussed the current climate at FDA and the numerous issues that the agency’s leadership has on its plate, including electronic health records, healthcare reform, import safety, cancer awareness, personalized medicine, and 510(k) reform.

Naples also discussed the latest advocacy activities in the IVD industry, in particular the push to modernize IVD regulations. He outlined the proposal that AdvaMed (Washington, DC) has submitted to FDA for modernizing the regulations, which includes the following principles:

• All clinical laboratories should be subject to the Clinical Laboratory Improvement Act (CLIA) requirements and quality standards.

• FDA should oversee the safety and effectiveness of all IVD tests no matter where they are made because they have the same risk-benefit profile for patients.

• FDA should focus its oversight of IVD tests primarily on the risk of harm associated with how the test result is used to treat patients.

• Patient access to specialized test categories (i.e., rare diseases and/or rare usage) should not be disadvantaged.

• FDA and CMS/CLIA should harmonize premarket and postmarket requirements for IVD tests, and maximize utilization of existing resources for the oversight of LDTs.

• The Medicare payment system must support timely and adequate reimbursement for all new IVDs.

According to Naples, one of the core concepts in AdvaMed’s proposal is that FDA should exempt well-established analytes on well-characterized platforms in which the risk is mitigated by the labs and other regulatory controls. The criteria for such an exemption include the following:

• Clinical uses of the test results are well established.

• Analytical performance characteristics are well established.

• The use and quality control of the IVD test systems are regulated by CMS under CLIA regulations.

• Changes in the performance characteristics that could affect safety and effectiveness will either be prevented, detected, or not cause serious injury.

• Device malfunctions or anticipated use errors would not present a high public health risk or lead to a high degree of morbidity or mortality.

• The device does not have a history of adverse events associated with failures to meet its performance specifications or otherwise perform as intended.

• The device conforms to any special controls specified in an FDA guidance document to provide additional assurance of safety and effectiveness.

Another speaker, Bradley M. Thompson, an attorney at Epstein Becker & Green (Washington, DC), gave a presentation on “FDA Regulation of Laboratory Developed Tests (LDT).” In his presentation, he delivered his case that FDA should regulate all diagnostics, including LDTs, and that the red herrings for not doing so are not valid.

The first red herring is that FDA does not have the resources to regulate LDTs. “The resources question does not have anything to do with differentiating between IVD kits and LDTs,” said Thompson. “At the most, it means FDA cannot regulate all tests and should focus on the riskiest IVDs. There is no evidence that LDTs are lower risk since there are no equivalent data sets.”

The second red herring is that FDA regulation will discourage innovation. “Innovation can come from nearly any sector, and the LDT policy is not directed at giving more latitude to those involved in innovation,” said Thompson. “The LDT policy is both overinclusive and underinclusive when it comes to innovation. It is underinclusive because there is plenty of innovation being done by IVD manufacturers, which needs to be encouraged. And it is over inclusive because many of the LDTs being developed are not at all innovative.”

The third red herring is that CLIA regulation is enough. The Federal Food, Drug, and Cosmetic Act provides the following: mechanisms for external review or approval, quality system regulation, mechanisms for postmarket reporting, and mechanisms for recalls of problematic tests. CLIA however has none of these elements.

Next year’s annual meeting will be held April 22-23, 2010. Additional information about AMDM can be accessed via its Website at www.amdm.org.