Medical Device Premarket Approval and Postmarket Inspections - Part V: Regulatory / Administrative Follow-Up

REGULATORY / ADMINISTRATIVE FOLLOW-UP

Refer to Part V of CP 7382.845, "Inspection of Medical Device Manufacturers," for a discussion of the specific criteria for determining Situation I and Situation II compliance decisions for PMA preapproval and PMA postmarket inspections.

1. PMA Preapproval Inspections

   FDA expects that the PMA device manufacturer's facility will be in compliance with the requirements of the device Quality System (QS) regulation. The manufacturer should have procedures in place to assure that specifications for the device, components, packaging, and labeling accurately reflect the design, and that the manufacturing process will consistently produce devices that meet the approved design. In cases where QS deficiencies are identified, any follow-up correspondence related to the deficiencies identified during the PMA preapproval inspection of the PMA devices will be issued by CDRH.

   1. Compliance Decision

      1. Situation I

         In cases where it has been determined that the QS deficiencies meet the criteria of Situation I, as outlined in Part V of CP 7382.845, "Inspection of Medical Device Manufacturers," FDA has the authority to withhold approval of the PMA application for that particular device. Therefore, the District should recommend withholding approval when the inspection identifies QS deficiencies that meet the criteria for Situation I, even though the District is not prepared to seek regulatory action because the deficiencies do not extend to other devices manufactured in the facility. Some significant QS deviation examples from Part V include, but are not limited to:

         • Total failure to define, document, or implement a quality system or one of the seven subsystems, such as failing to complete any required validations of full-scale production processes for the specific device covered by the pending original PMA application, or no procedures that address corrective and preventive actions.
         • A deficiency in one or more elements of the subsystems. The QSIT Guide can be utilized to provide guidance in determining what are considered to be "major" problems if not adequately addressed.
         • The existence of products that clearly do not comply with the manufacturer's specifications and/or the Quality System regulation, and which were not adequately addressed by the Corrective and Preventive Action Subsystem (CAPA) program.
         • Non-correction of major deficiencies from previous inspections.

         If the criteria of Situation I is met, CDRH will issue a PMA Official Action Indicated (OAI) Letter to the device manufacturer outlining the deficiencies identified during the inspection. The PMA will remain on hold and approval of the application will be pending resolution of QS deficiencies and often a re-inspection.

         When the PMA preapproval inspection is conducted in conjunction with another type of inspection that involves commercially-marketed devices, and the deviations extend beyond the scope of the PMA device to other devices manufactured in the facility, then the PMA application may be withheld and regulatory and/or administrative actions may be taken against the commercially-marketed devices to assure that the deviations are corrected. If legal action is not immediately warranted, a Warning Letter may be issued for only the commercially-marketed devices. Issuance of all Warning Letters should follow Chapter 4 of the Regulatory Procedures Manual (RPM). A separate PMA OAI letter may also be issued to the firm outlining the deviations related to the PMA devices. In such cases, a copy of the Warning Letter should be sent to the PMA preapproval coordinator in support of the District's recommendation to delay or withhold approval or the PMA application. It is important that before any Warning Letter is issued that CDRH also performs a QS Review of the EIR for the PMA aspect in order to ensure a uniform and consistent message between these two communications to the medical device manufacturer.

      2. Situation II

         In cases where it has been determined that the inspection meets the criteria of Situation II, as outlined in Part V of CP 7382.845, "Inspection of Medical Device Manufacturers," and deviations have been identified, CDRH will issue a PMA Voluntary Action Indicated (VAI) letter to the device manufacturer outlining the deficiencies noted during the inspection.

         Note: Districts should not recommend withholding the PMA application for inspections that meet the criteria of Situation II.

2. PMA Postmarket Inspections

   The determinations for Situation I or Situation II and any regulatory/administrative follow-up actions for PMA postmarket inspections should follow the guidelines discussed in Part V of CP 7382.845, "Inspection of Medical Device Manufacturers."

   1. Quality System Regulatory/Administrative Follow-Up

      Refer to Part V of CP 7382.845, "Inspection of Medical Device Manufacturers," for a discussion of regulatory and administrative follow-up actions for QS deficiencies.

   2. MDR Regulatory/Administrative Follow-Up

      Refer to Part V and Attachment C of CP 7382.845, "Inspection of Medical Device Manufacturers," for a discussion of MDR requirements and regulatory and administrative follow-up actions for MDR deficiencies.

   3. Tracking Regulatory/Administrative Follow-Up

      Refer to Part V and Attachment D of CP 7382.845, "Inspection of Medical Device Manufacturers," for a discussion of tracking requirements and regulatory and administrative follow-up actions for tracking deficiencies.

   4. Corrections and Removals Regulatory/Administrative Follow-Up

      Refer to Part V and Attachment E of CP 7382.845, "Inspection of Medical Device Manufacturers," for a discussion of corrections and removals requirements and regulatory and administrative follow-up actions for corrections and removals deficiencies.

   5. Registration and Listing Regulatory/Administrative Follow-Up

      Refer to Part V of CP 7382.845, "Inspection of Medical Device Manufacturers," for a discussion of regulatory and administrative follow-up actions for registration and listing deficiencies.

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