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Experienced researchers and technicians are at your service when you partner with American Preclinical Services. You gain one-stop access to full biocompatibility, interventional, and surgical research and pathology services within a world-class facility. ISO 17025 accredited, AAALAC accredited, USDA licensed, and GLP compliant, American Preclinical Services offers you the bundled resources you require to achieve rigorous medical device testing in a single laboratory operation.

Share on Google+ August 6, 2018

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US FDA FY 2019 MDUFA User Fees

Category : FDA, Regulatory

On 08/01/2018, the US Food and Drug Administration (FDA) published the user fee amounts it will collect in FY2019 from the manufacturers of medical devices. Current Law User Fees: +$2.791 Million (Center: +$2.755 million / Field: +$0.036 million) The Devices Program request includes an increase of $2.8 million for user fees authorized under Food and Drug Administration Reauthorization Act of

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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 13, 2018

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APS Adds Capacity, Capabilities, and Competencies to its Research Campus

Category : APS Service Offerings

American Preclinical Services (APS) is proud to announce the addition of a new cath lab, 25,000 sq ft of new laboratory space, 11,000 sq ft of new large animal housing capacity and a new Director of Toxicology. Located within the APS research campus, the new laboratory space will include a 7,000 sq ft analytical lab, a 5,000 sq ft in-vitro

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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+ January 19, 2018

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APS Regulatory Update: FDA Delays UDI Enforcement for Class I and Unclassified Devices

Category : FDA, Regulatory

US FDA has pushed back enforcement of unique device identification (UDI) compliance deadlines for some low-risk (Class I and Unclassified) medical devices by at least two years.  Table 1 below provides the compliance dates. Table 1: Compliance Dates for Class I and Unclassified Devices   Type of Device FDA does not intend to enforce UDI labeling (21 CFR 801.20 &

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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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