The new article describes in detail the content of the submission in terms of quality system information and also highlights the aspects related to the design control information. 






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. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed to ensure compliance thereto. At the same time, the document and provisions thereof are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations for the parties involved in operations with medical devices. Moreover, an alternative approach could be applied, provided such an approach complies with the respective regulatory requirements and has been agreed with the authority in advance. 

According to the guidance, the authority encourages medical device manufacturers to provide information in a structured way as this would simplify and streamline the review process. The FDA emphasizes the importance of ensuring that the information provided concerning the medical device in question and manufacturing facilities is comprehensive, accurate, and up-to-date. 

As it is stated by the FDA, the manufacturers shall explain where in [their] design and development process the device becomes subject to [their] design control program. 


Design and Development Planning 

According to the guidance, the submission should include the design and development plan(s), or a summary of the plan(s) covering the aspects related to the design inputs, outputs, review, verification, validation, transfer, changes, and history file. In particular, it should be described how the design input has been formed. Apart from this, it should be identified how the respective procedures are being reviewed, updated, and approved. 

As further explained by the FDA, design and development plans usually contain such elements and details as: 

  • The chronology of the development strategy (e.g., Gantt chart);
  • Outline the timing strategy (i.e., initiation, completion, and analysis);
  • Specification and justification of data needed prior to moving on to subsequent studies or activities referenced in the plan;
  • Specific deliverables for each stage;
  • Criteria for initiation, completion, and design review;
  • Critical milestones that must be completed before starting subsequent tasks;
  • Risk management activities. 

As prescribed by the applicable regulations, the analysis of the initial risk should be completed at the design validation stage, however, certain procedures related to the risk assessment should take place within the whole design process. 


Design Input and Output 

In terms of design input, the manufacturer should submit a copy of the respective written procedure describing the methods and processes applied. The elements to be addressed include, inter alia, the intended use of a medical device in question, its performance characteristics, the applicable safety requirements, and parameters, and also the aspects related to the toxicity, biocompatibility, and general compatibility with other products. Apart from the aforementioned aspects, it should also describe the approach applied concerning human factors and labeling. The authority also mentions that the list of key points provided in the guidance is not exhaustive, so it is important to consider the specific nature of the device in question and the risks associated thereto when deciding on the aspects to be highlighted. 

Concerning risks associated with the device, the authority mentions that all the potential risks should be duly identified to the maximum extent possible. At the same time, risk assessment activities should take place at all the stages of the development process since changes to the design could result in additional risks arising. 

Apart from the policy related to the design input, the appropriate policy should be provided to address the matters related to the design output. Such a policy should cover the aspects related to the design output acceptance criteria and describe the approach to be applied to ensure that all the aspects that are vitally important for the proper operations of a medical device are duly identified. The information to be provided in this section would be also used when assessing the design verification and design validation. 


Design Review, Verification, Validation, Transfer, and Changes 

According to the guidance, the manufacturer should also provide:

  1. A copy of the procedure(s) that define and control the design reviews for the device, describing the way the design review is undertaken. In particular, it should describe the procedures allowing the manufacturer to ensure that (a) design reviews are comprehensive and systematic; (b) all of the functions and people involved with the stage under design review are included in the design review; (c) an independent individual participates in all formal design reviews, and (d) any specialists that are needed participate in formal design reviews. Apart from this, the said policy should reflect the approach applied when documenting the respective matters. 
  2. A copy of the procedure(s) used to verify the device design for the device in question. Such a policy should contain the details regarding the procedure followed to ensure that the design outputs meet the design input requirements, and all the discrepancies are duly addressed. 
  3. A copy of the procedure(s) used to validate the device design for the device is subject to review. In this respect, the authority additionally emphasizes that in case the methods and approaches used could not be replicated in case of a full-scale manufacturing process, the manufacturer shall describe how they correspond to the ones that would be used. Apart from this, it is important to summarize how the clinical evaluations of the device ensure that the device meets user needs and the intended uses. In case the product in question contains computer software, the appropriate validation procedures should be described accordingly. As it was mentioned before, the risk analysis should cover all the stages of the design process. 
  4. A copy of the procedure(s) used to transfer the design output to manufacturing, should also contain a description of the way the final review and approval of the design should be performed. 
  5. A copy of the procedure(s) for controlling design change, describing the approach to be applied concerning changes to the initial design. In particular, the procedure(s) should explain how [the manufacturer] ensures that changes are validated or verified, reviewed, and approved before the design change is implemented. 

Apart from the aforementioned aspects, the manufacturer shall provide the details regarding the procedures for maintaining the contents of the Design History File (DHF). 

In summary, the present FDA guidance describes the approach to be applied to the design control information. The scope of the guidance covers the aspects related to the design input, output, verification, and validation.  







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