Pre-market Safety Assessment
The main component of ALTRAZEAL is poly-2-hydroxyethylmethacrylate (pHEMA), the same component in soft contact lenses that has been used safely, with proven biocompatibility, for many years.
While pHEMA has proven to be safe in contact lenses, current regulations require that manufacturers conduct adequate safety testing of their finished devices through preclinical and clinical phases as part of the regulatory clearance process. Included in this assessment is biocompatibility testing, which is the assessment of medical devices and their component materials to determine if there are undesirable effects when used clinically.
ISO and FDA guidelines provide a general testing framework to aid manufacturers in the assessment of device biocompatibility. Within the general safety testing framework it remains the responsibility of ULURU as the manufacturer of ALTRAZEAL to select and justify the specific tests most appropriate for the establishment of product safety and compliance with ISO and FDA guidelines. ULURU is committed to the quality and safety of ALTRAZEAL and has preformed biocompatibility testing to provide a safe device for wound care.
Therefore, ULURU has conducted tests in accordance with ISO 10993-1 and FDA G95 Guidelines for Devices. As a result of these tests, ALTRAZEAL has proven to be non-toxic and safe. Additionally, ALTRAZEAL components and packaging are latex-free.1
- Data on file. ULURU, Inc.