Regulation and Compliance
For years, the IVD industry, clinical laboratories, and patient groups have debated the appropriate regulatory scheme for laboratory-developed tests (LDTs). More recently, FDA has ventured into the debate. For example, in addition to taking some enforcement measures, FDA issued the in vitro diagnostic multivariate index assay (IVDMIA) draft guidance and the revised analyte specific reagent (ASR) guidance, both of which strive to help draw the dividing line between LDTs and IVDs. FDA's...
          Photo by iStockphoto Senators Arlen Specter (D-PA) and Ron Wyden (D-OR) introduced legislation that will improve access to lifesaving diagnostic tests for patients who might otherwise be denied. The Patient Access to Critical Lab Tests Act (S. 1220) will eliminate the complicated Medicare billing regulations that discourage hospitals from ordering laboratory tests needed to clarify complicated diagnoses and identify effective methods of treatment....
          Senate Finance Committee Chairman Max Baucus (D–MT) and Senate Budget Committee Chairman Kent Conrad (D–ND) introduced legislation to improve the quality of healthcare by ensuring doctors and patients have the best possible research and information on the effectiveness of different healthcare treatments.   “Doctors and patients don't have enough information on which treatments work best for which patients, and that increases waste,...
                Thomas Dzierozynski is senior partner at Avarent LLC (Libertyville, IL). He can be reached at thomas.dzierozynski @avarent.com. Thomas Ciesliga is an associate at Avarent LLC (Libertyville, IL). He can be reached at thomas.ciesliga @avarent.com. While a validation master plan (VMP) may not be specifically required by FDA, its use has become common practice in the medical device and diagnostic...
              The Joint Committee on Traceability in Laboratory Medicine (JCTLM) has listed more than 200 higher-order certified reference materials (CRMs) and more than 120 reference-measurement procedures used in laboratory medicine. CRMs and reference-measurement procedures for disease signatures and pharmacogenomic markers must be developed, and the JCTLM and its member organizations have begun to act. An “Ask the Industry” meeting in July...
            The Safe Medical Devices Act of 1990 converted the FDA notification process for medical devices entering the market into an FDA clearance requirement. The result was a backlog of devices awaiting FDA action. The scientific community and the medical device industry were displeased and voiced their concerns to Congress.   1997 FDAMA   It took several years, but Congress ultimately implemented changes designed to reduce 510(k)...
            In a proposed decision memo, CMS stated that it believes the available evidence does not demonstrate that pharmacogenomic testing to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries. The agency proposed that pharmacogenomic testing for determining warfarin response is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.   CMS agrees with most professional societies' recommendations...
  This editor's page features comments by Glen P. Freiberg, president of RCQ Consulting (San Diego) and a member of IVD Technology's editorial advisory board, on the 21st Century Cancer Access to Lifesaving Early Detection, Research, and Treatment (ALERT) Act:   The ALERT Act is intended as a comprehensive approach to cancer prevention, detection, research, and treatment. Historically, it has been a challenge to obligate insurers to allow coverage for preventive tests, so the...
      Calleja AdvaMed (Washington, DC) submitted a proposal to FDA at the end of March for modernizing premarket oversight of IVDs. The proposal, titled “Risk-Based Regulation of Diagnostics,” sets forth a risk-based “tier triage” model for regulating all diagnostic tests, regardless of origin.   The proposal was developed over the course of roughly two years, said Khatera Calleja, associate vice president, technology and regulatory affairs...
      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...