The article provides an overview of the regulatory framework related to the quality system information and highlights the most important aspects associated thereto. 






The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the quality system information for certain premarket application reviews. The scope of the guidance covers such application pathways as PMA, PMA Supplement, PDP, HDE, and Modular Review Submission. The document is non-binding and is intended to provide additional clarifications regarding the existing regulatory framework, and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, the authority mentions that an alternative approach could be applied, provided such an approach complies with the respective legislation and has been agreed with the authority in advance. 


Regulatory Background 

According to section 515(c)(1)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act, and 21 CFR Sec. 814.20., medical device premarket applications should contain certain components including, inter alia, a complete description of the methods, facilities and controls that are reasonably necessary for the authority to assess compliance with the good manufacturing practice requirements in the course of the manufacturing process. The present guidance is intended to assist medical device manufacturers in maintaining compliance with the respective regulatory requirements related to Quality systems (QS). As explained by the FDA, the appropriate information will be reviewed by the Office of Compliance, while the other elements of the application will be reviewed by the Office of Device Evaluation. The recommendations provided in the guidance should be considered to ensure the information included in the submission is provided in the appropriate format, as this will accelerate and streamline the review process. 

According to the guidance, the medical device manufacturer shall submit copies of written procedures or other documents whereby the elements related to the QS regulation are addressed. The authority also mentions that these procedures are to be developed and implemented to ensure compliance with the respective regulatory requirements. At the same time, the authority encourages medical device manufacturers to submit information related to the Quality System, even if such information falls outside the scope of information that is mandatory to be provided – this will reduce the need for additional requests the authority may send, should it find the information provided is not sufficient to complete the assessment. Apart from this, the authority also mentions that the completeness of the information provided during the initial stage would also impact the time needed for the authority to complete an on-site inspection. 

As was mentioned before, an alternative approach could still be applied, provided such an approach is in line with the general requirements and has been agreed with the authority before submission. In the course of preliminary negotiations, the authority will be able to point out the most important aspects to be considered, as well as the matters that could potentially raise concerns. The authority also emphasizes that during a pre-approval inspection, FDA may assess any of the requirements of the Quality System regulation, not just the ones referenced below. 

The Least Burdensome Approach 

According to the guidance, when developing the regulatory approach to be applied, the authority considers the regulatory burden medical device manufacturers would be subject to when taking actions to ensure compliance with the respective requirements. Hence, the approach described in the guidance is expected to be the least burdensome. However, medical device manufacturers may submit their suggestions related to the regulatory procedures and processes. 


QS Information: Structure and Format 

The authority further describes the way the information related to the quality system should be submitted to the FDA for review. In particular, the document addresses the following aspects:

  1. Format. According to the guidance, all the information related to the Quality System should be submitted at once. At the same time, the authority also mentions that if the design control information and the manufacturing information are submitted separately, as allowed in programs such as the PMA modular review process and the Product Development Protocol (PDP) process, this general information should be submitted with both submission; this will allow the reviewers ready access to this basic information with each submission under review and avoid possible delays in trying to reference this information for each submission. The authority also mentions that the applicants participating in a modular review may submit information in module(s) containing all the information which is necessary to complete the assessment of the safety- and performance-related matters. The documents containing QS-related information should be properly numbered to simplify navigation. It is also important to mention that in the case of several manufacturing sites involved, QS information should be provided for each of them separately. 
  2. Cover Letter. Each time submitting information related to the Quality System, an applicant should also provide the cover letter containing the details the authority will need to proceed with the application in the most efficient way. These details should include the information necessary to identify the applicant (e.g., contact details or reference numbers), details of contact persons, and also the indication of a specific date when the manufacturing site will be ready for inspection. The authority will use the said information when preparing for the on-site inspection.  
  3. What to Send. According to the guidance, the initial submission should include:
    1. A copy of [the] cover letter, as described above in item 2;
    2. A description of the device, including pictures, and where possible, the proprietary name, common name, model number(s), product code, and intended use; 
    3. A description of how the device works; and 
    4. The documentation is described in subpart B of this guidance document.

The authority also mentions that in case the aforementioned information is being resubmitted, an applicant should ensure the changes do not result in a PMA amendment required. 

In summary, the present FDA guidance highlights the most important aspects associated with the Quality System information and the way it should be submitted when applying for marketing approval. The document outlines the scope of information the authority expects to receive and also describes the particular way this information should be provided.







How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.