Volunteers sought for CDRH cloud submission pilot

Regulatory NewsRegulatory News | 08 October 2020 |  By 

Medical device firms can now apply to participate in a pilot US Food and Drug Administration (FDA) program for electronic delivery of medical device premarket submissions.
The pilot program, said FDA, provides a “voluntary alternate method” for developers to file premarket submissions to the Center for Devices and Radiological Health (CDRH) during the COVID-19 public health emergency. The pilot is intended to test the use of the Box cloud file sharing service, and to generate lessons learned that can be applied to the agency’s process for electronic delivery of premarket submissions.
Beginning 6 October, CDRH will accept up to 25 company-level participants for the program “who reflect the broad spectrum of applicants,” said the agency; selected applicants will each be allowed up to 5 premarket submissions. The pilot differs from the existing eSubmitter and eSTAR programs in that the new pilot program is a voluntary way to submit “what would otherwise be an eCopy,” according to the agency. The only difference from the usual eCopy format is that no physical media such as a DVD or flash drive is submitted and the eCopy is uploaded to Box; submission timelines will be unaffected.
FDA is interested in receiving feedback on how participants and others anticipate the pilot process will differ from mail submission of eCopies; what kind of information and feedback firms would find useful after a Box premarket submission; and what challenges FDA should anticipate when using Box for premarket submissions.
In December 2019, CDRH issued a final rule that shifted from requiring multiple paper copies of many submissions to a requirement for a single submission in electronic format. Submissions included in this shift away from paper included premarket notification submission (510k submissions), premarket application and supplements, humanitarian and investigational device exemption applications, and others. (RELATED: FDA finalizes rule to go from paper to electronic device submissions, Regulatory Focus 13 December 2019)
Firms are eligible to participate in the voluntary pilot program if they will be ready to submit a medical device premarket submission within 2 weeks of acceptance into the pilot; eSTAR submissions are not eligible for participation, clarified CDRH. Consultants may apply if their clients meet selection criteria and have not been separately selected to participate. Participants must also have or create a Box account and be able to upload files to the cloud sharing service.
Premarket submissions via Box are only available to participants in the pilot program, and CDRH may withdraw participants from participation in the program at its discretion for ineligibility. There are not separate user fees for participation in the pilot program apart from the otherwise applicable medical device user fees.
Firms interested in participating should submit a statement of interest to CDRH that includes a statement of agreement to participate and comply with eligibility conditions, a description of the planned premarket submission, and information about personnel numbers and annual revenue for the interested firm.


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