The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical device circulation, announced proposed changes to communication procedures between medical device manufacturers and other parties involved. In the course of such changes, the agency proposed a new rule on the application decision announcements and published draft guidance dedicated to communications regarding combination products. 

New Rule On FDA Decision Announcements


The agency proposed a new rule describing the way the decisions regarding premarketing applications will be announced. The new rule consists of the subsequent step towards the improvement of communications in the course of the premarketing application review. In the course of these improvements, the agency previously announced amendments to the submission procedures which introduced a single electronic form instead of the former requirement to provide paper documents in multiple copies.   

The scope of the proposed rule in particular covers approvals and denials for premarketing approval applications (PMA) and humanitarian device exemption applications (HDE). The changes proposed are also intended to reduce costs of conducting the appropriate operations. According to the rule, approvals and denials will still be publicly announced. The right to file a review request also remains available for interested parties. Under the existing regulation, an interested party has a right to file a request to review the decision within 30 days from the date of publication of the decision. It is also allowed to request additional copies of the documents. 

The agency also announced that the information on safety and effectiveness, namely the summary on PMA safety and effectiveness (SSED) and HDE safety and probable benefit (SSPB) would also be publicly available according to the principles of transparency and access to data important for health. 

The agency also proposes to implement the following changes:

  • To discontinue publishing lists of approvals and declines in the Federal Register on a quarterly basis. The information will be published on the homepage of the agency instead. 
  • To update the contact information of the agency in the appropriate sections.
  • To amend the procedure of copy request processing. At the moment, the requests regarding providing an additional copy of approval or denial decisions processed by the Freedom of Information Staff while in accordance with current legislation such requests should be filed to the Division of Dockets Management. This leads to forward the requests to the appropriate department resulting in additional delays and expenses that could be avoided. Thus, the agency proposes to set a rule providing that requests of this type should be filed directly to the Freedom of Information Staff that would process them further. 

According to the position of the agency, the proposed rule of being adopted could potentially increase the effectiveness of the review procedures carried out by the FDA’s specialists.  This will allow them to focus on the more important issues rather than duplicating the same information in several sources that brings no additional value to the parties involved. At the same time, the proposed rule does not impose any additional obligations on any industry representatives. 

FDA Improves Communications on Combination Products


Another important document published recently by the FDA describes the new approach to communications with the manufacturers of combination products. The guidance describes the way the agency would provide feedback to applicants on technical and regulatory questions. According to the existing legislation, feedback could be provided either in the course of the pre-application process or during special meetings with the representatives of the FDA arranged to discuss the most complicated issues before submitting an application. 

The guidance is focused on combination products which, in accordance with the definition provided, are products comprising of the device itself as well as any drug or biological product. Each and every separate element of a combination product is called a “constituent part”. According to the definition, a combination product is:

  • A medicinal product consisting of two or more elements which are either a medical device, drug or a biological product. 
  • Two or more medicinal products packaged and supplied together and intended to be used jointly for a purpose. 
  • Any medical device, drug or biological product intended by the manufacturer to be used exclusively with another medical device, drug or biological product despite being supplied separately. 
  • Any investigational medical device, drug or biological product intended to be used with the particular investigational medical device, drug or biological product specified by the manufacturer.

If the manufacturer needs additional clarification regarding its device to define whether it is a combination product or a constituent part, the manufacturer should file the appropriate request to the Office of Combination Product (OCP). This is a special division of the FDA responsible for this particular type of medical devices. The OCP also provides responses to all questions related to combination products. 

In particular, the agency emphasizes the importance of the following aspects:

  • The questions filed to the agency should be clear and relevant,
  • The information accompanying the request should be sufficient for the agency to provide a response that is relevant and accurate,
  • All communications should be performed through the proper channel as indicated by the agency. 

The FDA announced that applicants that act in accordance with the principles described above would be more likely to receive a response in a timely and accurate manner. 

The agency also specifies the scope of information to be provided by the manufacturer in order to process their inquiries, namely:

  • The information allowing the identification of the product subject to review as a combination product,
  • The detailed description of all components of the product. 

Depending on the particular components, the information should include the chemical name of the drug, dosing information, and also the references to application numbers of the devices or other medicinal products if applicable. The guidance also provides extended information on the Combination Product Agreement Meetings (CPAM), the procedure introduced by the agency to simplify the negotiation process.

To file a request under the CPAM procedure, the manufacturer should provide the following information: 

  • Name of the product and its detailed description,
  • Information on all components of the products,
  • Summary of all interactions with the agency and current product development status,
  • Request to arrange a meeting with the representatives of the agency,
  • Description of proposals with the FDA,
  • Data necessary to support the application,
  • The list of participants from the manufacturer’s side. 

The guidance partially relates to the FDA staff too. The agency advises its personnel to engage specialists from other departments if it could reasonably improve the effectiveness of the assessment and the quality of feedback provided. 

It is also important to mention that the document described constitute draft guidance and have been published solely for the purpose of receiving feedback. Thus, this guidance creates no obligation to any party involved.

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.