DET LLC is developing novel biomaterial medical devices for applications in wound healing, diabetic ulcer management, disease diagnosis (e.g., lyme pathogens), etc.

A Medical Device means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body of human and which does not achieve any of its primary intended purposes through chemical action. Based on risk, medical device is classified as Class I, Class II, Class III or De Novo. High risk devices needs clinical data (PMA). Low risk devices generally do not need clinical data (e.g., 510(k) exemption) 

Key terms and Services Provided:

• Investigational Device Exemption (IDE)

• Center for Devices and Radiological Health (CDRH)

• ISO 10993 series of standards

• Biocompatibility of a medical device refers to the ability of the device to elicit the desired biological response without causing adverse effects in the body. Biocompatibility depends on the body’s responses to the device as well as the device’s responses to the physiological environment inside the human body. ISO 10993-1/  FDA Biocompatibility Guidance, June 16, 2016.

• Toxicological activity of a medical device – Leachable chemicals / manufacturing residuals – Response to surface geometry/chemistry – Potential degradation products – Interactions

• Biocompatibility Endpoints – Cytotoxicity – Sensitization – Irritation/Intracutaneous reactivity – Acute Systemic Toxicity – Pyrogenicity – Subchronic & Chronic Toxicity – Hemocompatibility – Genotoxicity – Neurotoxicity – Implantation – Carcinogenicity – Reproductive/Developmental Toxicity – Immunotoxicity – Biodegradation

• GLP (21 CFR Part 58) Animal studies are intended to demonstrate that the device under study is sufficiently safe for early human experience [e.g., to support an investigational device exemption (IDE) application] or to demonstrate device safety in support of a marketing application. • Safety – Clinical observations – Histopathology;  • Performance – Device condition following use – Device specific functional endpoints – Labeling claims need to be substantiated

• Q-subs: The FDA will review proposed biocompatibility evaluation strategies and animal study rationale, design and protocols