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.
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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.
Information on sterilization, biocompatibility, expiration date, etc. Include the trade or proprietary name, if any, and the common or usual name or classification name of the device. A statement that, as required by the risk analysis, all verification and validation activities were performed by the designated individual s and the results demonstrated 3154 the predetermined acceptance criteria were met; and A statement that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 Gorm In 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.
In cases where 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. If a recent Quality System inspection has resulted in the issuance fogm a violative inspection report, the manufacturer should be prepared to describe those corrective actions taken, if needed, that form the basis for the declaration of conformity.
This tda should include the following: Provide the classification of the device, appropriate panel e.
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. 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.