The Food and Drug Administration (FDA) has published a guidance document dedicated to providing regulatory submissions for medical devices in the electronic format under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

Submissions in Electronic Format – Regulatory Background

In accordance with Section 745A(b) of the FD&C Act, certain submissions for medical devices should be filed in the electronic format as prescribed by the FDA. Such procedures should be applied for pre-submissions, submissions and any supplements thereto for medical devices under sections 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act. The initial guidance describing these types of submissions had been issued by the FDA earlier in October 2019 and the authority intends to issue its final version no later than twelve months after finishing the consultations period. In particular, the new regulation would establish:

  • New standards for submissions to be made in electronic format,
  • An implementation schedule, 
  • Conditions under which certain exclusions could be applied. 

The FDA states that “electronic submission templates … will serve as guided submission preparation tools for (the) industry to improve submission consistency and enhance efficiency in the review process.” It is also mentioned that certain types of submissions would be covered by separate guidance documents due to the different regulatory approaches to be applied. The FDA also reserves the right to publish updated guidance documents in order to improve and harmonize the existing submission process. 

The present FDA guidance on submissions for medical devices in electronic format does not establish any mandatory rules and requirements. Rather, it is only intended to provide medical device manufacturers and other parties involved in medical device operations with additional information regarding submissions under the Section 745A(b)(3) of the FD&C Act. Thus, an alternative approach could be used, providing that such an approach complies with the applicable requirements. The FDA guidance contains certain recommendations to be taken into account when preparing the submissions for medical devices under the aforementioned regulation. All references to such elements as “standards” or “criteria for waivers” are related to the mandatory requirements medical device manufactures and other parties shall follow.

Section 745A of the FD&C Act: Key Points

Section 745A, which introduces the submissions in electronic format, was initially added to the FD&C under the Food and Drug Administration Safety and Innovation Act (FDASIA) that entered into force on July 9, 2012. In particular, medical devices are regulated under section 745A(b), which was later supplemented by section 745A(b)(3). 

In accordance with the aforementioned regulation, the FDA is entitled to require all stakeholders to make submissions in electronic format. According to the same regulation, the FDA shall introduce the particular rules describing the way such submissions should be filed, including the timetable and exemptions. 

The FDA outlines the particular scope of submissions to be filed in the electronic format under section 745A(b). The scope includes, inter alia, the following types of submissions: 

  • Premarket notification submissions under section 510(k),
  • Requests related to the entirely new medical device (De Novo requests), related to Class III medical devices, filed under section 513(f)(2),
  • Premarket approval applications (PMA) under section 515(c), 515(d),
  • Modular PMAs under 515(c)(4),
  • Product development protocols (PDPs) under section 515(f),
  • Applications related to the investigational device exemption (IDE) field under section 520(g),
  • Applications related to the humanitarian device exemption (HDE) field under section 520(m),
  • Emergency Use Authorizations (EUAs) field under section 546, and others.

Upon the implementation of the electronic format, all submissions covered by the scope of the section 745A(b) should be submitted solely in electronic format. This rule should also be applied for all components of, and attachments to such submissions, and all amendments and supplements thereto. At the same time, the FDA explicitly states that the aforementioned rule should not be applied in case of Medical Device Reports submitted under 21 CFR Part 803. The electronic format should be also applied irrespective of the volume of the documents to be submitted. 

The FDA additionally emphasizes that all submissions will be received exclusively in electronic format, except the cases when such submissions are actually falling within the scope of some exclusions and exemptions. 

According to the FDA guidance on electronic format submissions for medical devices, in certain cases, the Agency is allowed to apply waivers related to the submission format requirements described herein. However, the document does not provide additional details regarding the particular way such waivers will be applied. 

Exemption From the Electronic Format Requirements

The guidance also describes specific types of submissions that are exempted from the electronic format requirements. In accordance with the initial regulatory provision, the authority is entitled to set forth special exemption rules itself. At the moment, the only exception already implemented by the FDA relates to the emergency use reports and adverse event reports. The authority encourages the parties involved to use the electronic format in spite of the fact it is not mandatory for such types of submissions. The authority also reserves the right to introduce additional exemptions. 

For some types of submissions, a special exemption should be applied only during the transition period, providing that the requirement on making submissions in electronic format will become mandatory as soon as the FDA will issue the appropriate guidelines and templates. As for now, the list of such “temporary” exclusions includes:

  • Master Access Files (MAFs),
  • 513(g) Requests for Information (513(g)s),
  • Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization requests and CLIA Waiver Applications (CW)

As was already mentioned before, the FDA will require filing the submissions of the aforementioned type in electronic format as soon as the appropriate templates will be available for the applicants.

Electronic Format Implementation Process

The FDA guidance also describes the way new requirements would be introduced by the regulating authority. In particular, the implementation process will include the following steps:

  1. Publication of draft guidance documents describing in detail certain specific aspects related to the new submission requirements.
  2. Indication of the public consultations period. 
  3. Publication of the final guidance on submissions for medical devices in electronic format. The final document will also contain an indication of the particular date the new approach should be implemented. 
  4. Revisions of the formats accompanied by the appropriate guidance documents. 

According to the FDA guidance, the particular implementation timelines for each type of submissions will be indicated in the appropriate guidance documents to be issued by the Agency. Upon the publication of the final guidance document, the requirements set forth herein would become mandatory for medical device manufacturers and other parties involved in operations with medical devices. 

Summarizing the information provided above, the FDA guidance on submissions in the electronic format under section 745A(b) describes the general rules regulating the way the new approach should be applied, the details regarding the availability of waivers and exemptions, and also the implementation process. 

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