Evaluation of Automatic. Class III Designation. (De Novo). APPLICATION CORRESPONDENT (e.g., consultant, if different from above). FORM FDA (6 /05). For this reason, FDA is allowing an alternative to the traditional method of. CDRH Premarket Review Submission Cover Sheet FDA Form tion. k Cover Letter Webinar you will learn how to prepare a k Cover Letter and complete FDA Form including identification of recognized standards.
In cases frm the referenced k was submitted under a different name than that of the submitter of the Special kFDA recommends that a statement to this effect be included in the Special k and that the submitter maintain adequate information demonstrating his legal right to distribute the device. Please note that a labeling change from prescription use to over the counter use, or vice versa, is considered a change in intended use and, therefore, is not eligible for the Special k method.
It is recommended that submitters of Special k s highlight, or otherwise prominently identify, all changes in the proposed labeling that may result from modifications to their legally marketed device.
This summary should include the following: Information on sterilization, biocompatibility, expiration date, etc.
ComplianceOnline Dictionary – Special (k)- Content/Format
Include the trade or proprietary name, if any, and the common or usual name or classification name of the device. Fform the classification of the device, appropriate panel e.
35114 addition, it should be clearly stated in the Special k that the intended use of the modified device, as described in its labeling, has not changed as a result of the modification s. Truthful and Accuracy Statement Class III Certification and Summary if applicable The name of the legally marketed unmodified device and the k number under which it was cleared.
A Special k should be well organized and formatted in sections, with page numbering, and include the required elements:.