Medical Device Link . Literature Review: Biological Safety of Parylene C

typical acute biological-safety testing profile, as specified in FDA's can cost in the neighborhood of $6000 and require 90 days to conduct. Subchronic, chronic, and carcinogenicity testing can add several thousand more to the price tag, and there is no guarantee that a material will pass the tests or that the test results won't raise further questions. Some manufacturers are turning to biological-safety literature reviews as a way of predicting the outcome of safety tests, and of sparing themselves the effort of rediscovering already established information. The article that follows is an example of such a technical report on the surface coating parylene C. Biological-safety literature reviews are not a new concept. states that "some devices are made of materials that have been well characterized chemically and physically in the and have a long history of safe use. For the purposes of demonstrating the substantial equivalence of such devices to other marketed products, it may not be necessary to conduct all the tests suggested in the FDA matrix of this guidance." The implication is that a suitable literature survey may suffice to establish substantial equivalence. Investigational device exempion submissions may also require biological-safety reviews. The report of previous investigations must include prior animal and laboratory testing, including summaries and bibliographies. A 510(k) summary should also include a review of the biological-safety literature when such a review helps support the argument of substantial equivalence. "The summary of adverse safety and effectiveness data . . . should be based upon a reasonable search of all information known or otherwise available. . . . " Procedures for Obtaining FDA Approval to Export Unapproved Medical Devices requires a manufacturer applying for an export permit for an unapproved device to submit (1) a statement certifying that a search of Medlars and Dialog databases has been made