FDA Registered Biocompatibility Testing Services in the USA

Current Situation:

On February 20, 2024, the U.S. Food and Drug Administration (FDA) reminded medical device sponsors and manufacturers to carefully evaluate third-party performance testing entities and independently verify all test results before submitting them to the FDA. Medical device companies are responsible for ensuring that the third parties generating the data are qualified and that all information submitted to the FDA is accurate and truthful.

In recent years, the FDA has discovered an increasing number of entities contracted by device companies ("third-party testing laboratories") producing falsified, duplicated, or unreliable testing data, raising concerns about the integrity of the data in the entire dossier.

The FDA also noted a rise in the number of applications with unreliable data submitted by many Indian laboratories. This troubling trend has led to the FDA's inability to determine substantial equivalence and authorize the marketing of devices containing such data. If a device cannot obtain authorization, sponsors and manufacturers are directly affected. Negative decisions reduce the opportunity for patients and healthcare providers to access new devices and may disrupt supply chains. Therefore, device companies must take action to prevent this situation.

China's JJR Laboratory, an FDA-authorized and recognized Chinese laboratory, has launched ISO 10993 biocompatibility projects to provide high-standard, reliable biocompatibility testing services for clients in the medical device industry:

Experience in Biocompatibility:

- Surface-contacting Medical Devices:

  - Skin Contact: Adhesive tapes, compression bandages, monitors, various electrodes, external prostheses, heating pads

  - Mucosal Contact: Endotracheal tubes, dental fillers, contact lenses, catheters, enteral medical devices, orthodontic materials

- Externally Communicating Medical Devices:

  - Indirect Blood Path: Infusion sets, adapters, extension sets, and blood input sets

  - Tissue/Bone/Dentin: Laparoscopes, arthroscopes, drainage systems, dental adhesives, skin staples, dental fillings

- Circulating Blood: Blood catheters, oxygenators, dialyzers and their accessories, blood adsorbers, immunoadsorbers, temporary pacemakers

- Implanted Medical Devices:

  - Bone/Tissue: Bone screws, bone plates, artificial joints, cardiac pacemakers, drug delivery devices, breast implants, artificial tendons, ligation clips

  - Blood: Pacemaker electrodes, heart valves, artificial blood vessels, drug delivery catheters, ventricular assist devices, artificial arteriovenous shunts

  - *The above medical devices include but are not limited to these examples*

JJR Laboratory Biocompatibility Testing Services:

ISO 10993-3 Genotoxicity:

- Ames Assay/2 Extracts

- Ames Assay with Confirmation/2 Extracts

- Chromosomal Aberration with CHO cells with Confirmation/2 Extracts

- Mouse Lymphoma Forward Mutation Assay with Confirmation/2 Extracts

- Mouse Micronucleus Assay/Blood/Flow/2 Extracts/Double Dosing

ISO 10993-4 Hemocompatibility:

- ASTM Hemolysis Complete (Direct and Indirect Contact)

- Modified ASTM Hemolysis (Direct Contact Only)

- Modified ASTM Hemolysis (Indirect Contact Only)

- In-vivo Dog Thromboresistance in 2 Non-Heparinized Animals (Direct Contact)

- In-vivo Dog Thromboresistance in 2 Animals (Direct Contact) – Heparinized Animals

- In-vivo Sheep Thromboresistance in 2 Non-heparinized Animals (Direct Contact)

- In-vivo Sheep Thromboresistance in 2 Heparinized Animals (Direct Contact)

ISO 10993-5 Cytotoxicity:

- NRU @ 1 Concentration

- NRU @ 4 Concentrations

- NRU Direct @ 1 Concentration

- NRU Direct @ 4 Concentrations

- MTT @ 1 Concentration

- MTT @ 4 Concentrations

- MTT Direct @ 1 Concentrations

- MTT Direct @ 4 Concentrations

- L929 MEM Elution Cytotoxicity

- Agar Diffusion Cytotoxicity

- L929 Cytotoxicity/Direct Contact

ISO 10993-6 Implantation:

- Muscle Implantation (various durations)

- Subcutaneous Implantation (various durations)

- Bone Implantation (various durations)

- Brain Implantation (various durations)

- Muscle Implantation (Bioabsorbable Material) with detailed histopathology

ISO 10993-10 Sensitization:

- Kligman Maximization/2 Extracts

- Kligman Maximization/Direct

- Buehler Sensitization/Direct Contact

ISO 10993-11 Pyrogenicity:

- Material Mediated Rabbit Pyrogen

- Material Mediated Rabbit Pyrogen/Direct

ISO 10993-11 Acute Systemic Toxicity:

- Acute Systemic Injection/2 Extracts

- Acute Systemic Injection/Direct

ISO 10993-11 Sub-Acute Systemic Toxicity:

- 1Abridged 28 Day Sub-Acute Systemic Toxicity by Implantation in Rat

- Fully compliant 28 Day Sub-Acute Systemic Toxicity by Implantation in Rat

- 1Abridged 14 Day Repeat Dose Sub Acute Systemic Toxicity by IV & IP in Rat (if product cannot be implanted)

- Fully compliant 14 Day Sub-Acute Systemic Toxicity by IV & IP in Rat

ISO 10993-11 Sub-Chronic Systemic Toxicity:

- 1Abridged 90 Day Sub-Chronic Systemic Toxicity by Implantation in Rat

- Fully compliant 90 Day Sub-Chronic Systemic Toxicity by Implantation in Rat

- 1Abridged 28 Day Repeat Dose Sub-Chronic Systemic Toxicity by IV & IP in Rat (if product cannot be implanted)

- Fully compliant 28 Day Sub-Chronic Systemic Toxicity by IV & IP in Rat

ISO 10993-11 Chronic Systemic Toxicity:

- 1Abridged 26 Week Chronic Systemic Toxicity by Implantation in Rat

- Fully compliant 26 Week Chronic Systemic Toxicity by Implantation in Rat

ISO 10993-12 Sample Preparation:

- Determination of Extractability

ISO 10993-23 Irritation/Intracutaneous Reactivity:

- Intracutaneous Injection/2 Extracts

- Intracutaneous Injection/Direct

- Intracutaneous Injection/Direct with Histopathology

- Primary Skin Irritation/Direct Contact

- Primary Skin Irritation/2 Extracts

- Primary Ocular Irritation/Direct

- Primary Ocular Irritation/2 Extracts

- 21 Day Ocular Irritation Study in Rabbits

- Primary Buccal Irritation/Direct

- Primary Buccal Irritation/2 Extracts

- Vaginal Irritation/Direct Contact

- Vaginal Irritation/2 Extracts

- Penile Irritation/Direct Contact

- Penile Irritation/2 Extracts

- Rectal Irritation/Direct Contact

- Rectal Irritation/2 Extracts

- Primary Bladder Irritation/Direct

- Primary Bladder Irritation/2 Extracts

ASTM F2888-18:

- ASTM Partial Thromboplastin Time (PTT) Assay (Direct Contact)

- ASTM Partial Thromboplastin Time (PTT) Assay (Direct Contact) with Predicate

- Complement Activation with C3a & SC5b-9 Cell Lines (Direct Contact)

- Complement Activation with SC5b-9 Cell Line Only (Direct Contact)

- Beta Thromboglobulin Test (BTG) (Direct Contact)

ASTM F2382-19:

- ASTM Platelet and Leukocyte Count (Direct Contact)

- ASTM Platelet and Leukocyte Count (Direct Contact) with Predicate

JJR Biocompatibility Service Content:

- Provide sample submission guidance and assist with customs clearance

- Develop clinical trial protocols and plans

- Arrange testing of products in collaboration with local laboratories/hospitals

- Collect, organize, analyze clinical trial data, and compile clinical reports

- Issue FDA-compliant biocompatibility reports signed by the laboratory PI

- Provide traceable sample records and original data

Contact us for detailed biocompatibility testing services and ensure compliance with FDA requirements for your medical devices.