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Hi,
I work for a medical device manufacturer regulated by the FDA. My question is regarding MDRs. We have access to the device for purposes of evaluating it, and therefore to include an MDR Evaluation Summary with the MDR (which FDA appears to require in such a case - see below).
The MDR Evaluation Summary appears to be required by the Instructions for Completing form 3500A:
H3: Device Evaluated by Manufacturer?:
Check the box marked not returned to mfr. if an evaluation could not be made because the device was not returned to, or made available to, the manufacturer. Check the box marked yes if an evaluation was made of the suspect or related medical device. If an evaluation was conducted, attach a summary of the evaluation and check the box marked evaluation summary attached. If an evaluation of a returned suspect or related medical device was not conducted, check the box marked no and attach a page to explain why not or provide the appropriate code from the codes manual10 in the space provided.
The MDR Evaluation is also mentioned in Part of CFR 803-Medical Device Reporting:
Sec. 803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me?
(e) If you are a manufacturer, you may maintain MDR event files as part of your complaint file, under part 820 of this chapter, if you prominently identify these records as MDR reportable events. We will not consider your submitted MDR report to comply with this part unless you evaluate an event in accordance with the quality system requirements described in part 820 of this chapter. You must document and maintain in your MDR event files an explanation of why you did not submit or could not obtain any information required by this part, as well as the results of your evaluation of each event.
My question is, what should be the content or elements of an MDR Evaluation Summary?
I work for a medical device manufacturer regulated by the FDA. My question is regarding MDRs. We have access to the device for purposes of evaluating it, and therefore to include an MDR Evaluation Summary with the MDR (which FDA appears to require in such a case - see below).
The MDR Evaluation Summary appears to be required by the Instructions for Completing form 3500A:
H3: Device Evaluated by Manufacturer?:
Check the box marked not returned to mfr. if an evaluation could not be made because the device was not returned to, or made available to, the manufacturer. Check the box marked yes if an evaluation was made of the suspect or related medical device. If an evaluation was conducted, attach a summary of the evaluation and check the box marked evaluation summary attached. If an evaluation of a returned suspect or related medical device was not conducted, check the box marked no and attach a page to explain why not or provide the appropriate code from the codes manual10 in the space provided.
The MDR Evaluation is also mentioned in Part of CFR 803-Medical Device Reporting:
Sec. 803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me?
(e) If you are a manufacturer, you may maintain MDR event files as part of your complaint file, under part 820 of this chapter, if you prominently identify these records as MDR reportable events. We will not consider your submitted MDR report to comply with this part unless you evaluate an event in accordance with the quality system requirements described in part 820 of this chapter. You must document and maintain in your MDR event files an explanation of why you did not submit or could not obtain any information required by this part, as well as the results of your evaluation of each event.
My question is, what should be the content or elements of an MDR Evaluation Summary?