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The FDA will periodically initiate pilot programs to help improve consistency and efficiency in 510(k) review. These pilot programs are intended to aid both industry and FDA staff in using resources effectively. This allows the FDA to direct more effort on the review of higher risk devices, which helps reduce total time to decision, and promotes consistency in 510(k) reviews. The programs do not alter the statutory threshold or data requirements for the determination of substantial equivalence.

eSTAR Pilot Program

Quality in 510(k) Review Program Pilot

Voluntary eSTAR Pilot Program

The electronic Submission Template And Resource (eSTAR) is a PDF electronic submission template that guides premarket notification (510(k)) submitters through the process of preparing a comprehensive medical device 510(k) submission. This template contains:

• Automation (e.g., form construction, autofilling);
• Content and structure that is complementary to CDRH internal review templates;
• Integration of multiple resources (e.g., guidances, databases);
• Guided construction for each submission section; and
• Automatic verification (i.e., FDA does not intend to conduct a Refuse to Accept review)

The voluntary eSTAR pilot program aims to improve consistency and efficiency in how the medical device industry prepares 510(k)s and how the FDA reviews these submissions. The FDA will evaluate whether the use of FDA's free eSTAR produces well-organized submissions that can be reviewed more efficiently, in comparison to submissions prepared as eCopies or with the eSubmitter application, to help promote timely access to safe, effective, and high-quality medical devices.

The eSTAR Pilot Program began February 27, 2020. To date, the FDA has selected nine participants who provide a general representation of the medical device industry and meet the selection criteria outlined within the Federal Register Notice. The FDA is currently not accepting requests for participation into the eSTAR Pilot Program.

How is eSTAR different from eSubmitter?

eSTAR is designed and structured in a similar format as FDA's 510(k) reviewers' Smart template, and includes a collection of questions, text, logic, and prompts that guides a user through preparation of a 510(k) submission. In addition, the functionality and content of the eSTAR application are embedded within a PDF which will allow industry more flexibility when developing, viewing, and editing a 510(k).

How to prepare a 510(k) for the eSTAR Pilot Program

1. Download either the Non-In Vitro Diagnostic eSTAR PDF or the In Vitro Diagnostic eSTAR PDF template. Be sure to save the document on your computer by right clicking the link, (or pressing 'control' + clicking on a Mac) and choosing Save Link As/Download Linked File, before you open it in Adobe Acrobat and begin entering in data.
   Note: This template is only used for constructing, not submitting, your 510(k) submission. The directions at the end of the template provide instructions on how to submit
2. Read, understand, and follow the directions in the Introduction, Key, FAQ, and Version History sections of the eSTAR PDF template.
3. Fill in the template accordingly.

Definitions:

eCopy: An electronic version of a medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. For further information see eCopy Program for Medical Device Submissions.

eSubmitter: A freely available FDA software program that contains electronic submission templates.

Electronic Submission Template: A collection of questions, text, logic and prompts within a template that guides a user through preparation of a complete 510(k) submission.

Electronic Submission Template and Resource (eSTAR): A PDF electronic submission template used by medical device submitters to prepare a medical device submission.

How to submit a 510(k) for the eSTAR Pilot Program

If you are participating in the voluntary eSTAR pilot program, your submission should include:

• The eSTAR PDF with embedded attachments on a CD, DVD, or USB Drive (SD cards are not accepted).
• A printed cover letter to the Document Control Center (DCC). For the current mailing address for CDRH's Document Control Center, see eCopy Program for Medical Device Submissions.

For example, during this pilot, an acceptable submission package would consist of a printed cover letter accompanying a USB drive containing the eSTAR PDF.

Participants of the eSTAR pilot program do not need to be eCopy compliant. The eSTAR PDF does not need to be zipped and placed in a MISC FILES folder.

How to submit responses to requests for additional information

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Indicate the submission is a supplement in the first section of the eSTAR 'Application/Submission Type.' After you indicate a supplement, an additional section will appear to provide responses to requests for additional information.

What are the eSTAR Pilot Program MDUFA User Fees?

510(k)s submitted as part of the voluntary eSTAR pilot program are subject to user fees. For the current User Fee amounts, please see MDUFA User Fees.

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What is CDRH Review and the Review Timeline?

After the FDA receives an eSTAR-prepared 510(k) within the eStar Pilot Program, the FDA does not intend to conduct the RTA process. The remainder of the review will be conducted according to the FDA guidance 'The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]' and the procedures identified in 21 CFR 807 subpart E.

Whom do I contact if I have questions?

Please contact eSubPilot@fda.hhs.gov if you:

• Have questions regarding the pilot or eSTAR content
• Find any malfunctions or errors in the eSTAR template
• Would like to provide feedback about the use of eSTAR. You can also comment on the docket in the Federal Register.

If you have questions regarding 510(k)s, please contact 510K_Program@fda.hhs.gov.

For general questions about medical devices, please contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, 800-638-2041, or 301-796-7100.

Resources

• Non-In Vitro Diagnostic eSTAR PDF - Be sure to save the PDF on your computer, by right clicking the link (or pressing 'control' + clicking on a Mac) and choosing to Save Link As/Download Linked File, before you open it in Adobe Acrobat and begin entering in data.
• In Vitro Diagnostic eSTAR PDF - Be sure to save the PDF on your computer, by right clicking the link (or pressing 'control' + clicking on a Mac) and choosing to Save Link As/Download Linked File, before you open it in Adobe Acrobat and begin entering in data.

Quality in 510(k) Review Program Pilot

The Quality in 510(k) Review Program Pilot provides an alternate method to submit a premarket notification (510(k)) to the FDA using the eSubmitter software to format the submission for certain device types. The FDA has identified a list of product codes that are eligible for this pilot. These device types are moderate risk and are considered to be well-understood by the FDA. This means the FDA believes these products can be reviewed in an efficient manner while still maintaining safety and effectiveness through a substantial equivalence determination. The goal is for the FDA to make a final decision within 60 days of receipt of a 510(k) for an eligible device.

The purpose of the Quality in 510(k) Review Program pilot is to evaluate the Quality in 510(k) Review Program and whether use of the FDA's free eSubmitter software will produce well-organized submissions that can be reviewed more efficiently to help promote timely access to safe, effective, and high-quality medical devices.

What are the eligibility factors for the Quality in 510(k) Review Program Pilot?

A device must meet all of the following factors to be eligible for participation in the Quality in 510(k) Review Program pilot:

1. The device's primary product code is listed below.
2. The device is not a combination product (such as a drug-device or biologic-device combination).
3. The lead Center for the device is the FDA's Center for Devices and Radiological Health (CDRH).
4. The submission was constructed with the eSubmitter template 'CDRH: Non-In Vitro Diagnostic Device - 510(k).'

If any of the above factors are not met, the submitter will have to submit the 510(k) using the traditional method of submitting a valid eCopy to the Document Control Center. If the submitter attempts to submit a 510(k) using the eSubmitter application for a product that does not meet the eligibility factors, it will be rejected for an invalid eCopy.

How to prepare a 510(k) for the Quality in 510(k) Review Program Pilot?

510(k)s submitted as part of the Quality in 510(k) Review Program pilot must be constructed using the eSubmitter software entitled 'CDRH: Non-In Vitro Diagnostic Device - 510(k).' Submitters should not use 'In Vitro Diagnostic Device - 510(k)'.

eSubmitter asks for the same information typically requested in a Traditional 510(k). After it is constructed, the eSubmitter application will format the submission into a ZIP file (the eSubmission package). This should be copied to a CD, DVD, or USB drive.

IMPORTANT: A cover letter must be included with the following statement to distinguish it as being part of the Quality in 510(k) Review Program Pilot. If this statement is not included, the submission may not be accepted into the Quality in 510(k) Review Program pilot. If the document is not accepted in to the Quality in 510(k) Review Program, it will be processed as a Traditional 510(k) submission.

'This submission is part of the Quality in 510(k) Review Program Pilot, and is organized according to the standard eSubmitter output package. Accordingly, special eCopy processing applies. As per the agreement for the Quality in 510(k) Review Program Pilot, no full paper copies are required.'

Instructions for downloading and installing the eSubmitter application are available at the eSubmitter Download and Installation website.

For further information on the eSubmitter Program, please see the CDRH eSubmitter Program section.

eSubmitter Icons

Expert View: Download gct semiconductor soc driver. If you click the Expert button in the top left of the eSubmitter application, you can view the structure of the information requested.

Folder icon: In Expert view, you can see whether a page is complete or incomplete by the presence of a check or question mark on each folder, respectively. eSubmitter will only allow you to package a submission when all folders have a check mark.

Yellow light bulbs: Help text is present for most of the questions in eSubmitter, and can be viewed by clicking the yellow light bulbs associated with each question.

Blue dots: Questions with a blue dot need to be answered before you will be allowed to package it into a ZIP file at the end.

How to submit a 510(k) to the Quality in 510(k) Review Program Pilot?

Send the submission to CDRH's Document Control Center. The current mailing address for CDRH's Document Control Center is provided on the eCopy Program for Medical Device Submissions webpage.

Note: Differences between eCopy and eSubmission

• An eSubmission package contains PDF attachments and XML file types. The XML files are intended for CDRH IT systems to process the application. Reviewers will not see these XML files.
• The parts of the eCopy guidance that describe the structure of a 510(k) submission will not apply to the Quality in 510(k) Review Program Pilot.
• An eSubmission is organized according to the layout of the information intake, which places administrative documents (e.g., Form 3674, the 510(k) Summary, the Truthful and Accurate statement) at the end of the submission because their applicability is determined based on the answers to questions in the body (e.g., Form 3674 is only required if the applicant indicates clinical data are included).
• Electronic signatures are used in the submission (e.g., on the Truthful and Accurate statement), rather than physical signatures.

To submit an amendment or supplement to the 510(k), please submit a valid electronic copy or eCopy to the Document Control Center, eSubmitter can not be used for an amendment or supplement.

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What are the Quality in 510(k) Review MDUFA User Fees?

510(k)s submitted as part of the Quality in 510(k) Review Program pilot are subject to user fees. For the current User Fee amounts, please see MDUFA User Fees.

What is CDRH Review and the Review Timeline?

If the submission is eligible for the Quality in 510(k) Review Program pilot, the refuse to accept (RTA) review will not be conducted. The review is expected to be interactive. This means that the FDA does not plan to put the submission on hold for a request for Additional Information (AI). Instead, submitters are expected to respond quickly to FDA requests for additional information.

A final decision for 510(k)s received as part of the Quality in 510(k) Review Program pilot is intended to be made by the FDA within 60 days of receipt.

Note: If the 510(k) is found to be ineligible for the Quality in 510(k) Review Program pilot, the FDA will email the official contact of the 510(k) to inform them of this decision and the reason why a review cannot be completed within 60 days. Then the 510(k) will be reviewed according to standard procedures using the traditional 90-day timeframe.

The following product codes are eligible for the Quality in 510(k) Review Program Pilot:

Whom do I contact if I have questions?

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If you have questions about the use of the eSubmitter application, such as packaging a submission, please contact esubmitter@fda.hhs.gov.

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If you find any malfunctions or errors, or would like to provide feedback about the use of eSubmitter, please contact eSubPilot@fda.hhs.gov.

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If you have questions regarding eSubmitter, options, or the Quick Review Program pilot, please contact 510K_Program@fda.hhs.gov.

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For general questions about medical devices, please contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, 800-638-2041, or 301-796-7100.