Avoid These Headaches During Regulatory Submissions

Our technical consulting group at Nelson Laboratories acts as a bridge between medical device companies and regulatory bodies, putting us in a good position to understand both sides and what they need from each other. This also creates an opportunity for us to recognize the typical deficiencies, mishaps, or errors that are identified by regulatory agencies during the submission process and to provide our expertise to medical device manufacturers about how to structure and document their submission paperwork to avoid some of these common mistakes. Oftentimes we receive feedback from FDA or a notified body that a submission is not fully substantiated with either testing data or evaluation information for a given medical device and intended use. When digging further into the submission paperwork and information available on the specific device, it frequently turns out that the data is actually there, but it was not well documented or is scattered throughout numerous files, making it more difficult for the reviewer to understand every piece of the puzzle. For instance, it is always recommended to perform a biological evaluation plan (BEP) for a given submission. A BEP provides a general description of the device and its intended use as well as evaluates the biocompatibility risks associated with that device in its intended application. In addition, it may review completed testing and published literature to propose a testing plan, if further mitigation of risk is needed from a bi...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news