PMA Testing

Premarket Application (PMA) testing is a series of FDA-required analytical techniques and studies to support pre-launch safety and efficacy claims for Class III medical devices. Infinity Laboratories provides comprehensive assays and robust data to support your Class III medical device filing and help safely deliver your product to market.

Expertise in Diverse Medical Device Materials

Class III medical devices can be composed of a diverse range of materials. The Infinity team has the experience needed to understand how your medical device works and the cutting-edge technologies necessary to perform testing on medical device materials, including: 

  • Polymers - Diverse Medical Device Materials
    Plastic, rubber, elastomer, coatings, adhesives
  • Metals - Diverse Medical Device Materials
    Alloys, electroplated material, titanium, stainless steel
  • Ceramics - Diverse Medical Device Materials
    Alumina, aluminum oxide, zirconia compounds
  • Specialty and composite materials - Diverse Medical Device Materials
    Specialty and composite materials

Medical Device Method Development & Validation

Infinity accelerates the path to market by developing and validating the appropriate tests for Class III medical device filings. Method validation services are performed under GMP and GLP conditions and follow ICH and USP guidelines for specificity, accuracy, and precision.

PMA Testing Services

Infinity provides the flexibility and service of a local lab with solutions of a national network. Our PMA testing is always conducted under the regulations of appropriate standard bodies, which include the United States, European, and Japanese pharmacopeias and ISO.

Chemical Characterization

Standard: ISO 10993

Chemical characterization of medical device materials, including polymers, metals, ceramics, and composites, to provide ISO 10993 biocompatibility data for regulatory filings. Additionally, tests characterize ancillary chemicals associated with device production, such as plasticizers, fillers, additives, cleaning agents, and release agents.

Medical Device Extractables & Leachables

Standard: ISO 10993 Chemical Characterization Testing

Set of methods to characterize complex chemical interactions in medical device materials (polymers, metals, ceramics, and composites) to characterize extractables and leachables properly.

Failure Analysis

Standard: Product Dependent

Conducted when the medical device does not meet performance criteria to find the root cause of the failure. Since failure can be caused by ingredients, contaminants, storage, and numerous other factors, failure analysis encompasses a diverse range of tests.

Impurity Identification

Standard: USP <232>, USP <233>

Detects and identifies unknown materials in medical devices under FDA and ICH recommendations.

Material Compatibility Studies

Standard: Product dependent

Seeks to understand whether or not the different component materials in a medical device, including a drug component, can negatively interact with each other and impact the performance or safety of the overall device.

Get in Touch

Want to learn more about our PMA testing services? Connect with one of our team members today.