The new article provides the details regarding certain specific aspects associated with the quality system information to be provided by the medical device manufacturer applying for marketing approval. 






The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the quality system information for certain premarket applications reviews. The document provides an overview of the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to achieve and sustain compliance thereto. At the same time, provisions of the document are non-binding in their legal nature. The authority additionally emphasizes that an alternative approach could be applied, provided such an approach is in line with the current legislation and has been agreed with the authority in advance. The scope of the guidance covers, inter alia, the aspects related to the least burdensome approach, design control, and manufacturing information. 


Final Acceptance Activities 

According to the guidance, the applicant should also provide a copy of the procedure(s) for final acceptance activities. Such a procedure should specify the particular criteria to be used for releasing the final device. These criteria should be based on valid scientific methods to ensure the accuracy and reliability of the results. It should be described how the final devices should be placed in quarantine before being released by the aforementioned criteria. In general, the policy should describe the measures intended to ensure that any device would not be made available for customers until:

  • Device Master Record requirements for release are met;
  • Review of associated release data and documentation;
  • Authorized for release by the signature of a designated person(s);
  • The date the final release is authorized is recorded.

Nonconforming Products 

The document also states that a policy regarding nonconforming products should be provided by the applicant. However, the authority mentions that such aspects could be also covered by the Corrective and Preventive Action (CAPA) procedure(s) – in such a case, it would be sufficient to provide the respective references. According to the guidance, such a procedure should cover identification, documentation, evaluation, segregation, and disposition of non-conforming products. The evaluation process described in the procedure should describe the grounds for commencing an investigation, and also the way the responsible person should be notified. It should be clearly stated how the evaluation of nonconforming products is related to the CAPA system. Furthermore, the procedure should also outline the documentation required to justify the use of such devices. 


Corrective and Preventive Action

The applicant should provide, inter alia, the procedure(s) related to the corrective and preventive action system developed and implemented by the manufacturer to ensure the public health protection and safety of the products it is responsible for. In particular, the document should describe the way safety corrective and preventive actions should be taken in the context of the overall risk management program, including the aspects related to the nonconforming products. Apart from this, the said policy should describe the approach concerning data collection and analysis. To ensure the effectiveness of the corrective and preventive actions, the following matters should be addressed:

  • Method for determining verification or validation;
  • Implementation planning to include recording changes in methods and procedures;
  • Method for disseminating information on the quality problem or nonconforming product to those responsible. 

As further explained by the FDA, the policy should outline the scope of information to be provided to the senior management for review in the context of corrective and preventive actions. The policy should also describe the way the changes to the design introduced in the context of CAPA interact with the general design control system; as well as the record-keeping requirements covering the matters to be documented as set forth under the applicable legislation. 


Complain Files 

Another important aspect to be covered by the policies the applicant shall submit is the procedure for handling complaints and Medical Device Reporting. These aspects could be also addressed in the CAPA policy – in such a case, the appropriate references should be provided. According to the guidance, the said policy should:

  • Outline the specific criteria to be used when determining whether an investigation is to be conducted based on the complaint received;
  • Prescribe a procedure of providing a written justification in case it will be determined that an investigation is not required (the authority additionally emphasizes that such a justification should contain the name of a person responsible for the decision taken);
  • Describe the process of MDR filing by the applicable regulatory requirements; 
  • Indicate the connection between the complaint handling procedures and the CAPA system.  



In the case the device in question is subject to servicing, the appropriate procedure should be also provided by the applicant. According to the guidance, the procedure should explain how information from servicing reports is coordinated with [the] complaint handling system to ensure that MDRs are filed with FDA when appropriate, and integrated into [the] CAPA system. 

In summary, the present FDA guidance describes the written policies and procedures to be submitted by a party applying for marketing approval about a medical device it is responsible for. The document also outlines the scope of information to be included in the said procedures, and the aspects to be addressed to ensure compliance with the applicable regulatory requirements. As was mentioned before, the authority employs the least burdensome approach reducing the scope of information and documentation to be submitted by the applicant to the minimum extent reasonably necessary for the FDA to complete the review of the premarket application. 







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