PMA Testing

• What is PMA Testing?

  Premarket Application (PMA) testing is the term used to describe the analytical techniques and studies needed to support safety and efficacy claims for a Class III medical device. According to the FDA, “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” Therefore, to support medical device claims and ensure patient safety, a variety of supporting data needs to be presented and approved by the FDA prior to marketing the device. This information includes data from clinical (studies in humans) and non-clinical studies such as toxicology, biocompatibility, material compatibility, and extractables and leachables studies.
  

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PMA Testing at EKG Labs

EKG Labs assists combination product and medical device companies seeking to provide data to support their PMA filing. Our regulatory and analytical knowledge enables us to develop custom non-clinical programs to demonstrate the safety and efficacy of a variety of novel Class III devices. Additionally, our expertise includes combination medical devices which incorporate a pharmaceutical component. Some of device classes we have experience with include:

• Intraocular Lenses and Implants
• Drug-Eluting Stents
• Bioabsorbables
• Wound Healing/Wound Care
• Cardiovascular
• Dental
• Drug Delivery
• Ophthalmology
• Orthopedic and Bone Healing
• Tissue Engineering
• Dermal Fillers
• Sinus Implants

PMA Testing – Analytical Services

In order to fully explore the safety and efficacy of a new medical device, it is critical to have a variety of analytical techniques to support product claims. EKG Labs’ state-of-the-art facility includes cutting-edge instrumentation operated by experienced chemical scientists who are adept at problem solving and working in a regulatory environment.

PMA Analytical Testing Services

• ISO 10993 Chemical Characterization
• Material Compatibility
• Extractables and Leachables
• Impurity Identification
• Method Development
• Method Validation
• Failure Analysis
• Compendial Testing

Analytical Techniques

• Chromatography – HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
• Spectroscopy – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
• Microscopy – SEM, TEM, AFM, STM, LSCM

PMA Testing – Device Material Expertise

Due to the diverse nature of Class III medical devices, a broad knowledge of material science is crucial when conducting a PMA testing program. At EKG Labs we have brought together a team of industry-leading scientists that understand the diverse interactions that can occur between various device materials and/or drug components. Our material expertise includes:

• Polymers: Plastic, Rubber, Elastomer, Coatings, Adhesives, etc.
• Metals: Alloys, Electroplated Material, Titanium, Stainless Steel, etc.
• Ceramics: Alumina, Aluminum Oxide, Zirconia Compounds, etc.
• Specialty and Composite Materials
• Pharmaceuticals: Drug Products and Drug Substances