The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the eCopy Program for medical device submission. The present document constitutes an updated version of the same guidance issued by the FDA earlier in December 2019

It is important to mention that due to its legal nature, the document does not introduce new rules and requirements to be followed but instead provides additional clarification and recommendations. The Agency also states that an alternative approach could be applied, providing it complies with applicable regulatory requirements and has been approved by the authority in advance. 

Regulatory Background

The present FDA guidance describes in detail aspects related to the eCopy Program for medical device submissions. In particular, the document describes the way the aforementioned program is being implemented by the regulating authority.

According to Section 745A(b) of the Food, Drugs, and Cosmetics (FD&C) Act, medical device submissions should be accompanied by an electronic copy (eCopy). The Agency states that such an approach could potentially facilitate the review of such submissions since the electronic version thereof would be immediately available for the regulating authority. 

The present document outlines the standards an eCopy should comply with in order to meet the admissibility criteria. Under the general rule, an eCopy is required in all cases for all submissions unless there is an exemption to be applied. Should a submission be submitted by the applicant without the admissible eCopy, the review of the submission would be placed on hold until the applicant provides the appropriate eCopy complaint with the applicable regulatory requirements. During the hold period, the review timeline should not be calculated. 

The FDA also states that the updated regulation “Medical Device Submissions: Amended Premarket Regulations that Require Multiple Copies and Specify Paper Copies to Be Required in Electronic Format” also contains the requirements related to the submission of eCopies. In particular, the aforementioned regulation repeals the requirement to submit paper copies. The Agency expects that this will reduce the regulatory burden for applicants interested in placing medical devices on the US market, and also facilitate the future transition to communications in electronic format only. 

Key aspects to be considered by the applicants with regard to submissions for medical devices and eCopies:

1. It is no longer necessary to submit paper copies of the submissions, but

2. A paper copy of the signed cover letter and one valid eCopy of the submission are still required. 

According to the applicable legislation, the Agency as a regulating authority in the sphere of medical devices is fully responsible for the implementation of eCopies for medical device submission, including all aspects related to the applicable standards, criteria for waivers, and exemptions. 

Thus, the present FDA guidance describes the current thinking of the Agency with regard to eCopies and regulatory requirements applicable thereto. However, as mentioned before, all information provided in the guidance should be treated as recommendations. 

The Agency additionally emphasizes that the eCopy Program described herein does not impact the actual amount and scope of data to be included in a submission. Hence, it covers only the aspects related to the use of the electronic format. 

eCopy: Concept in Detail

According to the present FDA guidance, an electronic copy (eCopy) is an electronic version of … medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. As mentioned before, an eCopy should be accompanied by a paper copy of the signed cover letter with either a wet or valid digital signature. 

The same approach could be applied to all the premarket submissions. It important to distinguish between an eCopy and an eSubmission – the latter stands for the package generated by an electronic submission template, and also contains the documents intended for computer processing. Such documents contain additional information regarding the structure of the submission and its version history. As stated by the FDA, an eCopy can be considered a static representation of the submission, while an eSubmission can be considered a dynamic representation of the submission. 

According to the present FDA guidance, an eCopy is required for the following submission types:

  • Premarket notification submissions (510(k)s), including third party 510(k)s
  • Evaluation of automatic class III designation petitions (de novos)
  • Premarket approval applications (PMAs), including Transitional PMAs;
  • Modular PMAs
  • Product development protocols (PDPs)
  • Investigational device exemption (IDE) submissions
  • Humanitarian device exemption (HDEs) submissions
  • Emergency Use Authorizations (EUAs)
  • Certain investigational new drug applications (INDs)
  • Certain biologics license applications (BLAs)
  • Q-submissions[1] 

An eCopy should cover all the elements of the submission, including supplementary documents and reports. The authority also mentions that an eCopy should be provided irrespective of the number of pages. Hence, an eCopy should be submitted even if the submission itself comprises a single document. At the same time, the FDA states that the submission package should not exceed 1 GB in order to avoid potential issues.

Additional Rules

The present FDA guidance also outlines certain additional rules to be considered by the medical device manufacturers and other parties involved. For instance, the scope of the submission provided as an eCopy should cover only the information mailed to the regulating authority. It should not include information communicated via phone. At the same time, the responses to the Interactive Review requests should be submitted as eCopies.

The FDA additionally describes the exemptions and waivers to be applied with regard to eCopy submission requirements. In accordance with the present guidance, certain types of submissions are exempted from the eCopy submission requirement due to the urgent nature of such submissions. These requests include all EUAs, as well as three specific types of IDE submissions: compassionate use submissions, emergency use reports, and adverse event reports. However, the FDA encourages all parties involved to submit eCopies for the types of submissions that fall within the scope of the aforementioned exemption since it could potentially accelerate the review process. Either way, an eCopy submitted should comply with the applicable regulatory requirements. 

With regard to waivers, the FDA states that the eCopy submission requirements do not create an unneeded burden for all the parties involved due to the availability of the software required. Consequently, the FDA does not consider the implementation of any waivers to be appropriate. 

Aside from the types of submissions listed above, the eCopy Program applies for:

–   Master Access Files (MAFs);

–   513(g) Requests for Information (513(g)s); and

–   CLIA Waiver (CW) and CLIA Request (CR). 

According to the present FDA guidance, submission of eCopies for such submissions is voluntary. 

I summary, the FDA guidance on the eCopy Program highlights the most important aspects associated thereto, including the types of submissions to be accompanied by the eCopies, as well as the applicable regulatory requirements. The regulating authority states that the implementation of the eCopy Program could potentially facilitate the review of the submissions.

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