About Toxicological Data Assessment Consulting, LLC

Toxicological Data Assessment Consulting, LLC (TDAC) is a dedicated small business providing comprehensive support for toxicological risk assessment of medical devices. Our services also include preparation of biological evaluation plans and reports, extractables testing study design, laboratory oversight, analytical data review, and consulting assistance for regulatory submissions.

TDAC has extensive regulatory expertise encompassing a range of standards and guidelines, such as ISO 10993-1 through 10993-18; EU 2017/745, EU 722/2012, ISO 21726, ISO 14971, ISO 22442, ISO 19227, ICH M7, Q3B, Q3C, Q3D, and Q3E; ISO 7405, ISO 18562, ISO 16000-6, USP 1663 and 1664; FDA Draft Chemical Characterization Guidelines; ASTM F1980-07; SCHEER phthalate guidelines; EMA 169430; and FDA device-specific guidelines.

Toxicological Risk Assessment (TRA) experience:  With a track record spanning 28 years, TDAC has authored more than 245 TRAs and peer reviewed over 189 reports. TDAC’s principal toxicologist has been consistently successful in obtaining 510(k) clearances from US FDA, CE mark approvals under EU MDR, and medical device approvals from Japan PMDA and China. Additionally, TDAC has conducted toxicological risk evaluations of medical device manufacturing changes, nonconformances, and contamination incidents. TDAC has extensive experience in toxicological literature research. For example, in a previous role TDAC’s principal toxicologist contributed toxicity profiles for 85 to 90% of chemicals assessed by a staff of 10 toxicologists.

TDAC has experience preparing TRAs for various medical devices, including drug product delivery systems and container closure systems (CCS), catheters, cardiac valves, pumps, and stents, hemodialysis devices, in situ curing bone cements, in situ polymerizing cyanoacrylates, transdermal patches, intraosseous needles, breast implants, wound dressings, tissue scaffolds, craniomaxillofacial reconstruction implants, orthopedic and dental implants, surgical instruments, bioresorbable sutures, 3-D printed bone scaffolds, humidified breathing circuits, respiratory inhalers and nebulizers, gas delivery systems, CPAP devices, and breathing tubes.

Analytical Consulting:  With over 40 years of expertise in analytical chemistry, TDAC specializes in mass spectral data interpretation and extractables study design, execution, and data evaluation. TDAC collaborates with Contract Research Organizations (CROs) to rectify compound misidentifications, reassess mass spectra, and conduct independent NIST library searches. In total, TDAC has prepared over 300 proposals for extractable/leachable (E/L) testing of medical devices and drug product shelf life studies.

Biocompatibility Support:  TDAC has authored or peer reviewed more than 60 biological evaluation plans (BEPs) and biological evaluation reports (BERs) submitted to regulatory bodies such as US FDA, EU notified bodies, and Japan PMDA. TDAC’s expertise includes biocompatibility assessments for new product development, supplier material changes, manufacturing process changes, and CAPA remediation projects.

Regulatory Support:  TDAC has successfully addressed a variety of regulatory deficiency comments from FDA, EU notified bodies, and Japan PMDA. TDAC has performed root cause analysis of biological test failures and developed justifications that demonstrate negligible risk to patient safety. Additionally, TDAC has collaborated with CROs to present supporting data for precision, accuracy, and reliability of analytical methods, which successfully resolved regulatory concerns regarding analytical data quality.

Professional Organizations and Committees:  TDAC actively engages in professional organizations and committees to stay at the forefront of industry developments and contribute to the advancement of toxicological risk assessment. Our affiliations include:

Board Certified Diplomate of the American Board of Toxicology (DABT); certification valid until 2030

Association for the Advancement of Medical Instrumentation (AAMI)

• Workgroup 11:  Allowable Limits for Leachables (ISO 10993-17, ISO 10993-7)
• Workgroup 14:  Material Characterization (ISO 10993-18, ISO 10993-19)
• AR-Workgroup 03:  Respiratory Devices and Related Equipment (ISO 18562)

Society of Toxicology (SOT)

• Subcommittee for In Silico Quantitative Structure Activity Relationship (QSAR)
• Subcommittee for medical devices

American College of Toxicology (ACT)

If you are interested in our services, please refer to the GET STARTED menu.