Life is a Journey..how to make the best of it!

BayBiotech.NET ISO 10993 describes a set of standards for evaluating the biocompatibility of a medical device prior to a clinical study. Based on these guidelines, agency’s modified guidelines entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," describes a FDA-modified matrix that designates the type of testing needed for various medical devices. Main criteria to consider when selecting the appropriate tests for biological evaluation of a medical device are the chemical characteristics of device materials and the nature, degree, frequency and duration of its exposure to the body. In general, the main type of tests include: acute, sub-chronic and chronic toxicity; irritation to skin, eyes and mucosal surfaces; sensitization; hemocompatibility; genotoxicity; carcinogenicity; and, effects on reproduction including developmental developmental effects. However, depending on varying characteristic

BayBiotech.NET The eCTD submission requires construction of XML based backbone for the submission with strict guidelines for file name size, pdf style and hypertexting format. Although the XML based backbone is a choice for submission as it gives an advantage by making the submission independent of operating system environment, but also imposes some issues for a successful submission. In order to avoid the pitfalls and delay in response of obtaining RTF (refuse-to-file) along with the expertise in preparing high quality .pdfs for submission and expertise in XML is also required. On analyzing the various tools available in the market, my recommendation will be to use caution in using such tools without double checking the submissions and having an independent quality check of your own as such tools are still at prelim phases of development and as a sponsor you may not wish to bet your million dollar investment on a RTF. A good quality .pdf, an accurate XML coding as well as strict