nick-otto-articles

  1. FDA Proposes New Study To Test Device Labeling Standardization 9/17/2014

    The FDA is taking steps to further study the feasibility of standardizing device labeling using new formats currently under development.

  2. Congressional Leaders Question FDA Decision To Regulate LDTs 9/12/2014

    Congressional leaders this week grilled FDA officials on the agency’s legal authority to regulate lab-developed tests (LDTs), asking if new requirements would trigger additional costs to laboratories, and whether the FDA itself had the necessary resources to take on the task.

  3. Medical Devices Experience Fewest Recalls Since 2012 9/10/2014

    The medical device industry saw its lowest number of recalls since 2012, according to new research from Stericycle, an industry recall consultancy.

  4. FDA Green Lights First Device To Assess Risk For Acute Kidney Injury 9/9/2014

    The FDA recently allowed marketing for a first-of-its-kind device used in determining if certain critically ill, hospitalized patients have an imminent risk of developing acute kidney injury (AKI).

  5. FDA Finalizes 510(k) Requirements For HMMD Manufacturers 9/4/2014

    Manufacturers of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) should be ready to justify their performance characteristics in 510(k) or de novo submissions, according to recently finalized FDA guidance.

  6. FDA Releases FAQ Guidance On UDI System 9/2/2014

    The FDA released new guidance on the unique device identifier (UDI) system in the form of frequently asked questions (FAQs). The guidance summarizes key aspects of the agency’s UDI final rule, taking into consideration industry comments and questions.

  7. NIH Issues Final Genomic Data Sharing Policy 8/29/2014

    A new final policy from The National Institutes of Health (NIH) will give scientists of government-funded research six months to load any collected genomic data into a government-stablished database. The policy will apply to all researchers with NIH-funded grants who are conducting large-scale human and non-human projects that generate genomic data.

  8. FDA Guidance Advises Industry To Monitor Gender Equality In Clinical Trials 8/23/2014

    The FDA recently released final guidance advising device makers performing clinical trials to consider the gender distribution of study participants throughout various points of a study.

  9. China Food And Drug Administration Updates Clinical And Registration Requirements 8/22/2014

    The China Food and Drug Administration (CFDA) last month released revisions (in Chinese) to administrative measures that, on Oct. 1, will affect the way medical devices are registered in the country.

  10. Final Guidance Cuts Pre-Decisional IDE Review Process 8/22/2014

    The FDA’s recent final guidance encourages device makers to perform clinical studies using the agency’s Investigational Device Exemption (IDE) regulations, but nixes a proposed program aimed at speeding the clinical assessment process.