Tuesday, June 8, 2010

FDA IVDMIA Rule, PMA, 510(k) Application and Clinical Submission

Often discussed today, is the delay by FDA on its final rule on In Vitro Multi-Variant Index Assays (IVDMIAs). The delay is mainly due to a request by the Office of Management and Budget. The delay will impact IVDMIA development, regulatory rigor and review, guidance, requirements and clinical submission via PMA, 501(k) and otherwise. In 2007, FDA released a draft guidance to the industry pertaining to governance, compliance, safety, effectiveness, substantial and certifiable equivalence. Since July 2007, numerous discussions, forums, conferences, working sessions with FDA and interested groups have taken place with best efforts to resolve FDA concerns pertaining to high risk to patient safety. The delay of course in the past 3 years have impacted companies that are application and clinical submission ready with go-to-market IVDMIA strategies and final image products and kits.

The delay, uncertainty and concern of FDA has slowed investor participation. Uncertain of regulatory rigor, requirements and thus timelines and costs, investors are shy to invest. ROI is uncertain. Approvals are uncertain. Pre- and post-market guided enforcements, surveillance and commitments by FDA involving IVDMIA are uncertain. Best efforts to release a final rule by FDA with interested parties in 2009-2010 are ongoing. Currently circulating since March 2010, is a "notice of proposed rulemaking" from FDA for IVDMIAs. The process allows a 60 day public comment, review and appeal period followed by a 30 day period for FDA, government response. Interested parties are hopeful for a final rule from FDA June 2010. Not likely. Maybe end of summer 2010, maybe end of year 2010. FDA's concerns are but not limited to:

  • high risk to patient safety
  • product effectiveness
  • product validity
  • clinical validation
  • clinical outcome determination
  • clinical diagnosis
  • clinical interpretation
  • product surveillance, pre- and post-market
  • regulatory enforcements, requirements and guidance
  • complicated, complex diagnostic array platforms
  • molecular and proteomic complexity
  • observation correlations between multivariate data and clinical outcome
  • IVDMIA considered a unique device, case by case
  • how to regulate IVDMIA devices to ensure a safe and effective intended use
  • patient reliance upon IVDMIAs with high risk diagnosis
  • patient reliance upon IVDMIAs and intended use to make health care decisions when FDA has not ensured that the IVDMIA has been clinically validated.

In the most current draft guidance, FDA emphasizes additional enforcement discretion. FDA considers IVDMIAs of high risk intended use since they include elements that are more complex than standard CLIA/LDTs and include unique interpretation functions that cannot be independently validated by clinicians. FDA seeks to identify and measure IVDMIAs as a discrete category of device. Companies must meet pre- and post-market device requirements under the Federal Food, Drug and Cosmetic Act and FDA regulations, including pre-market review requirements following Class II and Class III devices. Regulatory rigor and review, quality control, quality assurance, clinical interpretation of accurate, normal range determinations, false positive and false negative samples are a must. Quality process and management plans are a must. High quality sample and testing data is a must. For innovative development, application, 510(k), PMA clinical submission, FDA communication, quality data and monitored, project-lead and managed development contactus@danteresources.com, danteresources@yahoo.com.

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