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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+ September 24, 2018

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FDA Proposing to Amend Medical Device Premarket Regulations to Remove Paper and Multiple Copies and Replace them with Requirements for a Single Submission in Electronic Format

Category : FDA

FDA Proposing to Amend Medical Device Premarket Regulations to Remove Paper and Multiple Copies and Replace them with Requirements for a Single Submission in Electronic Format (proposed Rule) Executive Summary The US FDA has proposed to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic

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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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