The US FDA Has Updated Its Guidance On Identifying And Responding To Deficiencies (FDA Deficiency Guidance)

The US FDA recently revised the guidance document for identifying and responding to deficiencies in accordance with the Least Burdensome Provisions. Under the same title, one more document was issued on November 2, 2000. FDA guidance documents do not pose obligations; rather, they provide clarification regarding the applicable regulatory requirements.  

This FDA guidance document will be helpful for the agency staff to develop requests for additional information needed to make a decision on a medical device marketing application. Here the term “deficiency’ is used for the requests for additional information for medical device marketing applications. FDA guidance recommends the most efficient format for industry to respond to such deficiencies. As an FDA 510(k) consultant, we advise industry people to respond to questions or request additional information in a way that will enable them to be satisfactorily answered.  

The objective behind the FDA deficiency guidance describes the approach the authority will apply when requesting the additional information for marketing approval.  

This particular guidance document describes the way appropriate responses should be provided for additional requests by medical device manufacturers. For this purpose, document provide examples of deficiency and responses to be provided, it also describes how the authority will describe the deficiencies. The information about deficiencies communicated to the applicants in two ways  

• The course of interactive review  
• Deficiency letter issued by the authority. 

Most of the time authority communicate through email or phone to avoid the delays. 

Key points to consider while writing deficiency letter in marketing application  

• The information related to marketing authorization decision should be included only. 

• The least burdensome or very minimum amount of information required to fully address the indicated problem should be requested in deficiency letter. 
• Uncertainty in making benefit risk determination for PMAs and De Novo should be considered  

In a nutshell, the FDA guidance documents provide an overview approach which is to be applied to the deficiencies in the context of least burdensome approach.  it is advisable to the applicants to provide complete response to all deficiencies within indicated timeframe asked by the authority.  in the process of response to the query or additional information our team will stand beside you. Just email us your query or you can whatsapp us your requirements we will answer you shortly. 

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 References : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-responding-deficiencies-accordance-least-burdensome-provision