FDA biocompatibility of a wound dressing, with subsequent risk assessment of a potential leachable


A worldwide manufacturer of wound care products, who required a biological evaluation and biocompatibility assessment.


The company markets adhesive and non-adhesive wound dressings that include a foam layer containing a polymeric antimicrobial agent. In order to meet the FDA requirements as a medical device, the dressing, which is defined as a surface device with permanent contact with breached or compromised skin, required a biological evaluation and biocompatibility assessment.

Project goals

Bibra was asked to evaluate the systemic subacute, subchronic and chronic toxicity as well as the genotoxicity and carcinogenicity of the foam layer by carrying out a toxicological risk assessment, in line with the principles of ISO, FDA and other expert guidance. Furthermore, bibra derived a Tolerable Intake (TI) as well as Tolerable Exposure (TE) and Allowable Limit (AL) figures for different patient subpopulations (neonates, young children and adults) for the potential antimicrobial leachable, following ISO 10993-17 guidance.


Bibra conducted a comprehensive literature review, and identified the key systemic toxicity and carcinogenicity studies. From these data, a TI was derived and, subsequently TEs and ALs were calculated for the patient subgroups. In addition, worst-case leachable exposures were estimated based on dressing sizes, application frequency and maximum values for the elution limit.

Margins of Exposure (MOEs) for the potential leachable were calculated, by comparing these conservative exposure estimates with the derived AL values, for each subgroup.

Project outcome

Bibra derived health-precautionary AL values using FDA and ISO 10993-17 guidance for three separate patient subgroups. For each patient group, the Margins of Safety were >1.0, demonstrating that the leachable would not pose any significant systemic health risks to patients. Furthermore, bibra justified that further animal testing on the wound dressing is not necessary, and the medical device has good ISO 10993 biocompatibility.

Bibra project team

Pete Watts


Medical Devices

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