FDA CDRH Defibrillator Draft 510(k) Guidance

FDA CDRH Office of Device Evaluation’s “Draft Guidance for Implantable Cardioverter-Defibrillators Version 4.2” June 19, 1994. Section II.B addresses this so for documentation requirements for 510(k) submissions for this type of medical device by simply referring to the general software submission guidance and the Off-the-shelf software Submission guidance. Earlier versions of this draft at additional more stringent requirements especially for avoiding the use of Off-the-shelf software for such devices so this version seems to allow more leeway in this regard. This is a lengthy guidance and since there is little related to software in it the actual document is not provided here but is available at the FDA website by doing a search of the good guidance practice documents in the Office of Device Evaluation.