Resources

What is FDA 510k Pre Submission A FDA Pre Submission is a formal written request from a submitter for feedback from FDA that is provided in the form of either formal written response or, if the submitter chooses, formal written feedback followed by a meeting. Such a Pre Submission meeting can be in-person or by teleconference as the submitter prefers. A FDA Pre Submission provides the opportunity for a submitter to obtain FDA feedback prior to an intended premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND), In FDA Pre Submission face-to-face or teleconference meeting with [...]

Biocompatibility of Medical Devices Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best-designed products could produce unintended complications if the materials used, cause a biological reaction in the patient. An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with the biological system. It studies the interaction between the device and the various types of living tissues and cells that are exposed to the device when it comes into contact with patients. Almost all medical devices that come in contact with human tissue require biocompatibility [...]

Medical Device Shelf life Shelf-life is the length of time you can expect a product to look and act as expected and to stay safe for use. This length of time varies, depending on the type of product, how it is used, and how it is stored. Medical devices containing highly sophisticated electronics that are lasting longer than before, raising the bar for safety and liability. The concept of shelf-life/expiration date was created to help consumers realize when a product should be discarded. Expiration date of the medical device states the termination of shelf life. After expiration date medical device may no [...]

Medical Device Sterilization Most surgical and medical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. Such items include surgical instruments, biopsy forceps, and implanted medical devices. Sterilization is a process that effectively destroy all microorganisms from the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. [...]

Literature Search and Review Protocol Clinical Evaluation Report with incomplete documentation of the literature search and review will lead to a non-conformity. Because the MDCG document 2020-13 specifically requires notified bodies to verify the literature search documentation, this can result in unnecessary questions or even audit variations. A search methodology is used to carry out a literature search and review protocol and other data retrieval. The search protocol documents the planning of the search forward to its execution. The process for literature search and review is stated in Appendix A5 of the MEDDEV 2.7/1 guidance. Importance of Developing a [...]