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Because recalls usually involve situations that present risks to health, modifications intended to correct the cause of a recall usually will satisfy this criterion. The above approach will not be used if sufficient information to assess the modification is not readily available from a firm during the recall process such as when extensive testing is needed. It is our job to keep up with the changes that FDA makes to the k process. Approach The attached chart summarizes the decision process that CDRH will use to determine whether the review of a proposed correction will be conducted solely through the recall process or with the k process. You will have to determine the best method to case study on csr ppt substantial equivalence of your device to FDA.

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If, however, ODE determines that the modification could not significantly affect safety or effectiveness, no k submission will be required and OC's case officer will process the recall accordingly.

The device that we match your device to is called a predicate device. The purpose of the abbreviated review will be to ensure that the k submission is administratively complete, and that it includes only the modification s already found acceptable by CDRH as part of the recall process.

  • Because recalls usually involve situations that present risks to health, modifications intended to correct the cause of a recall usually will satisfy this criterion.

During the recall process, ODE with input from other offices, if appropriate will attempt to assess whether the modification appears to be an adequate correction, and whether the modified device will be "substantially equivalent. Effective Date This memorandum is effective immediately. We review the predicate together and then set a plan in motion for your new device.

There has to be guidance documents from FDA for the specific medical device that is to be cleared. If the correction just restores the device to its original specifications e. It is our job to keep up with the changes that FDA makes to the k process.

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There are specific guidelines for this k clearance. The following procedures will be used to assess a proposed correction that requires a k submission. Abbreviated k: You will have to determine the best method to prove substantial equivalence of your device to FDA.

A special control has been established by FDA for this device and consensus standards.

FDA (k) Cover Letter Contents

In this case, no k issue is involved and OC's case officer will process the recall accordingly. The guidance was the subject of review at two Center "poststaff" meetings at which input and comments were received from all Center offices, as well as meetings of OC's and ODE's senior staff.

Approach The attached chart summarizes the decision process that CDRH will use to determine whether the review of a proposed correction will be conducted solely through the recall process or with the k process.

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The above approach will not be used if sufficient information to assess the modification is not readily available from a firm during the recall process such as when extensive testing is needed. We have a list of the documents that are needed for your specific device.

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If the correction appeared to be appropriate, the Center exercised enforcement discretion and allowed the firm to implement the correction for units of the device that were already distributed. When the guidance is available, ODE will refer to it in making this decision.

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A device is substantially equivalent if, in comparison cdrh cover letter a predicate it: However, the original IDE clinical investigation remains approved and may continue. In general, ODE will attempt to assess the correction during the recall process, and will not repeat this assessment when reviewing the k submission.

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This is the method to prove to FDA that your new device is at least as safe and effective as the predicate device. You will have to determine which k is correct for your device with FDA. This guidance is not intended to apply to: