Specialty Coating Systems can play a vital role in helping medical device manufacturers go to market with their advanced technologies by offering specific regulatory support to its worldwide service customers.
Before going to market with a new drug or device in the United States, manufacturers must complete a submission to the U.S. Food and Drug Administration (FDA) that demonstrates the new product to be both safe and effective for its intended use. When completing a submission to the FDA, the manufacturer needs to address the safety of the finished product, including any surface treatment modifications such as Parylene coating.
For years, SCS has provided helpful resources to customers for their device submissions. SCS maintains Device and Drug Master Files with the FDA, which include the biocompatibility studies on SCS Parylenes per ISO 10993 Biological Evaluation of Medical Devices. These tests include cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity (acute), implantation and hemocompatibility. Also included in the files are additional test data and research describing the behavior of Parylene in a wide variety of applications related to medical markets
SCS’ Master Files are available for reference by SCS commercial coating customers. Once a customer completes an application to the FDA, authorization is given to the FDA examiner to refer to SCS’ files on behalf of the customer’s submission. SCS’ Master Files are maintained at the FDA, and their contents are viewable only by FDA examiners and authorized SCS personnel. SCS’ authorization allows the FDA to then review information in the files, while preserving proprietary information.
For markets outside of the United States, coating service customers who are applying for approval can be assisted when SCS provides a Summary Certificate of Biological Evaluation of Medical Devices. This third party statement lists the ISO 10993 tests completed and passed for the Parylene variant that will be provided in the coating service contract. When the customer presents this impartial certificate with their submission, governing bodies in these markets view it favorably, giving it ample consideration during their examination.
When seeking a partner for Parylene coating services, the availability of regulatory support can assist the approval process by answering key questions regarding the safety and reliability of Parylene conformal coatings on medical devices. For more information on SCS medical coatings or to answer any questions on the regulatory submission process, contact Sr. Medical Market Specialist Dick Molin at firstname.lastname@example.org or 317.244.1200, Ext. 271.