Medical Device Premarket Approval and Postmarket Inspections - Field Reporting Requirements

FIELD REPORTING REQUIREMENTS

1. PMA Preapproval Inspections — PAC Code 83001

   All Premarket Approval (PMA) preapproval inspection assignments should be completed by the due date specified in the assignment. All PMA Establishment Inspection Reports (EIRs) must be received by the Center for Devices and Radiological Health (CDRH) within 30 calendar days from the ending date of the inspection.

   Forward all PMA approval or non-approval recommendations to CDRH's Field Operations Branch (FOB) via e-mail at the address listed below. For non-approval recommendations, state the reasons why approval should not be granted. Districts must not wait for final completion of violative and non-violative inspection reports before notifying CDRH of their recommendation.

   Once the EIR is completed, the endorsement coversheet should be labeled as "PMA Preapproval Inspection," include the PMA number that was covered during the inspection, and the FDA Field Accomplishments and Compliance Tracking System (FACTS) assignment number. Send the EIR, any FDA 483, exhibits, attachments, and firm's responses by e-mail to the PMA preapproval coordinator at CDRHPMAPROGRAM@fda.hhs.gov. Ensure that the subject line of the e-mail utilizes one of the following nomenclatures:

   1. PMA Preapproval — EIR — Name of Manufacturer/Sterilizer Site — FEI Number
   2. PMA Preapproval — Firm's Response — Name of Manufacturer/Sterilizer Site — FEI Number

   Note: When an inspection is conducted that includes both a PMA preapproval inspection and another type of inspection covering commercially-marketed products (postmarket, routine, compliance follow up, etc.) and the recommendation is Official Action Indicated (OAI), the District may have direct reference to take administrative actions on the inspection covering the commercially-marketed products. However, CDRH would also need to review the inspection for the preapproval PMA device covered during the inspection before any direct reference action is taken on the commercial product so that consistent information is supplied to the firm for all products. If the documents related to the PMA preapproval inspection are placed in the Case Management System (CMS), an e-mail notification that includes the CMS number should be sent to CDRH's PMA preapproval coordinator at the e-mail address listed above.

2. PMA Postmarket Inspections — PAC Code 83001A

   All PMA postmarket inspection assignments should be completed by the due date specified in the assignment. The results of the postmarket inspection must be received by CDRH within 30 calendar days from the ending date of the inspection. A Notification of PMA Postmarket Inspection Form (Attachment A) should be completed for each inspection and returned to the PMA postmarket coordinator via e-mail.

   Action Indicated or Voluntary Action Indicated, forward the FACTS coversheet and EIR narrative to the PMA postmarket coordinator via e-mail to the address listed below.

   For domestic PMA postmarket inspections where CDRH review is requested or the District has classified the inspection as OAI, and all foreign PMA postmarket inspections, the endorsement coversheet should be labeled as "PMA Postmarket Inspection," include the PMA number that was covered during the inspection, and the FACTS assignment number. Send the EIR, any FDA 483, exhibits, attachments, the firm's responses, and any correspondence issued to the firm to the PMA postmarket coordinator at CDRHPMAPROGRAM@fda.hhs.gov. If the documents related to the PMA postmarket inspection are placed in CMS, an e-mail notification that includes the CMS number should be sent to CDRH's PMA postmarket coordinator. Ensure that the subject line of the e-mail utilizes one of the following nomenclatures:

   1. PMA Postmarket — EIR — Name of Manufacturer/Sterilizer Site — FEI Number
   2. PMA Postmarket — Firm's Response — Name of Manufacturer/Sterilizer Site — FEI Number

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