Applied Silicone offers long-term implantable silicone products test data and regulatory documentation for medical device submissions to the FDA.
Applied Silicone Corp. officials announce the availability of material compendia detailing the physical, chemical, and biological testing of the raw material specific to each long-term implantable silicone product offered by the company. This valuable service provides the user with an extensive summary of the supporting documentation available, in electronic format, for regulatory review and submissions for Class II and Class III medical devices.
Material compendia allow device manufacturers to avoid redundant pre-clinical physical, chemical, and biocompatibility testing of the material for regulatory submissions, such as 510(k), IDEs, and PMA pre-market notifications. Each compendium is a highly organized summary of physical property data, chemical properties, and the biological testing conducted on each product. The documentation is supported with references to corresponding Master Access Files (MAF) that are registered with the U.S. FDA. For international medical device submissions, the compendium is customized to address the requirements set forth by regulatory bodies in the country of submission.
“Applied Silicone’s regulatory team has assembled comprehensive directories that are both product and customer specific,” states Annabelle Cortez, quality manager of Applied Silicone Corp. “An organized summary of material testing is an indispensable guide for regulatory reviewers.”