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  1. How to Study and Market Your Device

Electronic Delivery of Premarket Submissions Pilot

The FDA’s Center for Devices and Radiological Health (CDRH) is no longer seeking volunteers to participate in the Electronic Delivery of Premarket Submissions Pilot (referred to later as “Pilot”), which provides a voluntary alternate method to submit a premarket medical device submission to CDRH for 90 days during the COVID-19 public health emergency.1 2 Enrollment is now closed.

On this page:

What is the purpose of the Pilot?

The purpose of the Pilot is to:

  • Test CDRH’s capabilities to receive premarket submissions using Box (a cloud file sharing service)

What is the duration of the Pilot?

CDRH will begin accepting volunteers to participate in the Pilot beginning October 6, 2020. This Pilot is intended to last 90 days during the COVID-19 public health emergency.

How does Electronic Delivery of Premarket Submissions Pilot differ from eSubmitter and eStar?

eCopy, eSTAR, and eSubmitter provide different ways to create and/or submit an electronic submission; whereas, this Pilot provides a voluntary, alternate mechanism to submit what would otherwise be an eCopy.  The structure and format of the submission remains the same as described in the eCopy guidance but instead of mailing the eCopy on physical media (for example, CD, DVD, flash drive), the submission will be uploaded to Box.

Who is eligible to participate in the Pilot?

Eligibility to participate in this voluntary Electronic Delivery of Premarket Submissions Pilot Program is limited to those applicants who:

  • Intend to submit a premarket submission for a medical device in the form of an eCopy within 2 weeks of acceptance to the voluntary Electronic Delivery of Premarket Submissions Pilot Program.  For information on the submission types that can otherwise be submitted as an eCopy, and are eligible for this pilot, please see the eCopy Program for Medical Device Submissions (eSTAR submissions are not eligible for the Pilot);
  • Have the capability to upload files to Box (a cloud file sharing service), which will be used in the Electronic Delivery of Premarket Submissions Pilot. If you do not have a Box account, you will need to create one; and
  • Follow the procedures for requesting participation.

At its discretion, CDRH may withdraw a participant from the voluntary Electronic Delivery of Premarket Submissions Pilot Program if the participant is ineligible.

If you are not part of this Pilot, you cannot use Box to submit what would otherwise be a premarket eCopy.

How do I request to participate in the Pilot?

To be considered for the voluntary Pilot, submit a statement of interest to [email protected]. The statement of interest should include:

  • Statement of agreement to participate and comply with the eligibility conditions of the Pilot,
  • Description of the premarket submission(s) that will be submitted within two weeks of acceptance into the Pilot, and
  • Information on the size of the organization (specifically the number of personnel and the amount of revenue per year).

How will CDRH select and notify participants?

CDRH has selected and notified 25 participants, defined at the company or organization level, who meet the eligibility criteria and who reflect the broad spectrum of applicants to participate in the Pilot. Enrollment in the Pilot is now closed.

Is there a Medical Device User Fee for submitting a submission through the Pilot?

Premarket Applications submitted as part of the Pilot are subject to applicable user fees. There is not a separate User Fee for the Pilot.  For the current User Fee amounts, please see MDUFA User Fees.

Does the Pilot affect the FDA review timeline?

No. Participation in the Pilot will not impact the review and timeline.

Who do I contact with questions about the Pilot?

If you have questions about the Electronic Delivery of Premarket Submissions Pilot, the selection qualities, or the use of Box for cloud file sharing in this Pilot, email [email protected].

What feedback can I provide about use of Box?

FDA invites all interested parties, including pilot participants, to provide feedback on the use of Box to submit premarket submissions. Feedback may be submitted to Docket # FDA-2020-N-1850.  Please consider the following when providing your feedback:

  1. How do you anticipate this electronic submission process will compare to submitting eCopies by mail?
  2. What kind of information would you find helpful to be included in email communications upon submission of a premarket submission using Box?
  3. What types of challenges should the Agency be thinking about concerning the use of Box to submit premarket submissions?

1 Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. January 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration has been renewed for an additional 90 days  on April 21, 2020; July 23, 2020; and October 2, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-23June2020.aspx).
2 This Pilot is only intended to last for 90 days during the  COVID-19 public health emergency. This draft guidance refers to previously approved collections of information subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).  The collections of information in the following FDA regulations and guidance have been approved by OMB: 21 CFR part 807, subpart E (0910-0120); 21 CFR part 814, subparts A through E (0910-0231); 21 CFR 814, subpart H (0910-0332); 21 CFR 812 (0910-0078); the guidance document “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” (0910-0756); the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (0910-0844); “FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act” (0910-0705); the guidance document “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” (0910-0598); the guidance document " User Fees for 513(g) Requests for Information" AND "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff" (0910-0705).

This pilot refers to previously approved collections.

 

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