The CDRH 510(k) eSubmissions Pilot Program is a new voluntary route for submitting 510(k) applications that guides the user through constructing and submitting a 510(k) submission electronically, eliminating the need for a hard copy or a compact disc.
Pilot submissions will help refine the process by which CDRH gathers data and documents, and it will ensure that the software infrastructure functions work properly.
FDA is now accepting limited requests to participate in the CDRH 510(k) eSubmissions Pilot.
Eligibility
Participation in the CDRH 510(k) eSubmissions Pilot is voluntary and open to sponsors whose submissions are reviewed in the Office of Device Evaluation’s (ODE) Division of Cardiovascular Devices Cardiac Diagnostic Devices Branch or Peripheral Interventional Devices Branch. The type of devices that are covered in the Pilot include (this is not an exhaustive list):
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Blood pressure monitors
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Arrhythmia detectors
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Electrocardiograms
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Multiparameter monitors
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Diagnostic computers
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Diagnostic catheters
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Atherectomy catheters
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Embolic protection devices
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Angioplasty catheters
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Embolectomy catheters
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Guidewires, introducers, guide/support/infusion catheters
We encourage 510(k) sponsors of all device types, including those reviewed in other branches, to review the user interface and provide feedback via the Federal Register (FR) docket. We will evaluate participation in the pilot to determine the need to expand to include other device types.
The CDRH 510(k) eSubmissions Pilot is limited to unbundled, traditional 510(k) submissions for classified devices only. We are not accepting third party 510(k)s or Combination Products in the CDRH 510(k) eSubmissions Pilot at this time.
Duration
The FDA will accept requests for participation in the CDRH 510(k) eSubmissions Pilot through September 30, 2014, or as resources and the CDRH 510(k) eSubmissions Pilot needs allow. The FDA is limiting the CDRH 510(k) eSubmissions Pilot to approximately 50 – 100 submissions and may further limit the number of submissions from an individual firm.
Getting Started
Sponsors interested in volunteering to participate in the CDRH 510(k) eSubmissions Pilot should email the CDRH 510(k) eSubmissions Pilot staff at eSubpilot@fda.hhs.gov and include the name of the device and primary product code in the email. This email address is also for reporting issues and asking questions. FDA will only accept 510(k) eSubmissions from sponsors that first contact us at this email address and are accepted into the pilot.
Once sponsors are accepted into the pilot, they should follow the CDRH 510(k) eSubmissions Pilot User Guide for the process of submitting a 510(k) eSubmission.
Submit general comments regarding the CDRH 510(k) eSubmissions Pilot for CDRH Electronic Submission of Premarket Notification Submissions at http://www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville MD 20852. Identify comments with the docket number FDA-2014-N-0366 from the FEDERAL REGISTER notice.