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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Include the trade or proprietary name, if any, and the common or usual name or classification name of the device.
A concise summary of the design control activities. Provide the classification of the device, appropriate panel e. 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 33514 a result of the modification s.
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 that 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 CFR 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.
ComplianceOnline Dictionary – Special (k)- Content/Format
If a recent Quality System inspection has resulted in the issuance of 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.
A Special k should be well organized and formatted in sections, with page numbering, and include the required elements:. 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 ofrm 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.