Similarly, for an in situ polymerizing and absorbable sealant, where the materials present will change over time, separate evaluations of the pre-polymerized, polymerized, and degrading sealant may be needed." FDA's Biocompatibility Guidance on Use of ISO 10993-1, Section IV. For example, if a metal stent has a polymer coating that may separate over time, then the results of a final device biocompatibility assessment may not fully reflect the longer-term clinical performance of the device, and biocompatibility evaluation of the stent with and without the coating may be needed. This is particularly important when the combination of device components could mask or complicate interpretation of a biocompatibility evaluation. However, sponsors should understand the biocompatibility of each device component and any interactions between components that could occur. Source: "This guidance considers the assessment of biocompatibility to be an evaluation of the medical device in its final finished form, including sterilization, if applicable.The FDA assesses the biocompatibility of the whole device and not just the component materials. It is the intention of the FDA to assess biocompatibility in a way that is least burdensome for both industry and FDA reviewers. How the FDA Assesses or Evaluates Biocompatibility Source: "When assessing new devices, the sponsor should specifically state if the device does not have any direct or indirect tissue contact, and no further biocompatibility information would be needed." FDA's Biocompatibility Guidance on Use of ISO 10993-1, I. If a device does not have any direct or indirect tissue contact, then the FDA does not need biocompatibility information in the submission. Similarly, medical devices such as implants or skin electrodes also should be assessed for biocompatibility." FDA's Biocompatibility Guidance on Use of ISO 10993-1, I. Source: "For example, masks or gloves intended for protective purposes by clinical practitioners should be assessed for biocompatibility.Source: "For the purposes of this document, the term 'human body' refers to either patient tissues or the clinical practitioner." FDA's Biocompatibility Guidance on Use of ISO 10993-1, I.Note that the term body can refer to a patient undergoing a medical procedure or any other person such as a medical practitioner. Source: FDA's Biocompatibility Guidance on Use of ISO 10993-1, I."Medical devices that come into direct contact or indirect contact with the human body" are evaluated "for the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body." Background on the FDA's Guidance on Biocompatibility.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |