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Category Archives: Medical Device testing

Share on Google+ July 18, 2018

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E&L Chemical Characterization & Hexane Extracts: GC vs. LCUVMS Analysis

Category : Analytical, Chemical Characterization, Extractable/Leachable, Medical Device testing

As a contract laboratory providing extractables and leachables (E&L) services we are often asked about the time and cost required to perform chemical characterization of a medical device. Per FDA definition and guidance: Latest Guidance on Device Classification “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.” Herein lies the

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Share on Google+ March 12, 2018

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Medical Device Innovation: Dealing with Challenges

Category : Medical Device testing

Event Date and Time Thursday, April 12th, 2018 4:30 PM – 7:30 PM CST Location American Preclinical Services 9055 Evergreen Boulevard Coon Rapids, MN 55433  Description Cost: FREE         Join APS and Medical Alley for a night of networking and discussions surrounding medical device innovation. Three industry professionals will provide insights into dealing with challenges seen during

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Share on Google+ October 30, 2017

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FDA Finalizes 510(k) Guidances on When to Submit a New 510(k)

Category : FDA, Medical Device testing, Regulatory

On October 25, 2017, the FDA released two final guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes and complements the broader guidance document.  These guidance documents

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Share on Google+ September 4, 2017

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FDA Announces the Medical Device User Fee Rates for Fiscal Year 2018

Category : FDA, Medical Device testing

On 29 August 2017, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2018.  The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees are for certain medical

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Share on Google+ July 10, 2017

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Pathology Matters, part 2 of a 3 part series: Assessing Histopathology Results

Category : Histopathology, Interventional Medicine, Medical Device testing

Part 1 of this series described the preclinical study types relying heavily on histopathology data: device safety, biocompatibility, and systemic toxicity. Here we focus on strategies for histopathology data assessment. Preclinical study histopathology data can generally be divided into three types: Qualitative Quantitative Semiquantitative Qualitative histopathology uses description to document tissue changes and is more applicable to studies where the

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Share on Google+ June 12, 2017

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Pathology Matters, part 1 of a 3 part series: Preclinical Studies and Histopathology

Category : Histopathology, Interventional Medicine, ISO, Medical Device testing

The histopathology evaluation in preclinical studies is performed to support the study objectives. The study type, tissues examined, and intended data use all determine what pathology analysis is needed. Here we review the preclinical studies that rely heavily on histopathology data. Histopathology is a key component of these preclinical study types: Device safety studies Biocompatibility studies Systemic toxicity studies These

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