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The FDA will periodically admit pilot programs to advice advance bendability and ability in 510(k) review. These pilot programs are advised to aid both industry and FDA agents in appliance assets effectively. This allows the FDA to absolute added accomplishment on the ysis of college accident devices, which helps abate absolute time to decision, and promotes bendability in 510(k) reviews. The programs do not adapt the approved beginning or abstracts requirements for the assurance of abundant equivalence.

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The Quality in 510(k) (“Quik”) Analysis Program provides an alternating adjustment to abide a premarket notification (510(k)) to the FDA appliance the eSubmitter software to architecture the submission. The FDA has articular a account of artefact codes that are acceptable for this pilot. These accent types are abstinent accident and are advised to be well-understood by the FDA. This agency the FDA believes these articles can be advised in an able abode while still advancement assurance and effectiveness. The ambition is for the FDA to accomplish a final accommodation aural 60 canicule of cancellation of a 510(k) for an acceptable device.

The purpose of the Quik Analysis Program pilot is to appraise the Quik Analysis Program and whether use of the FDA’s chargeless eSubmitter software will aftermath able submissions that can be advised added calmly to advice advance appropriate admission to safe, effective, and high-quality medical devices.

A accent charge accommodated all of the afterward belief to be acceptable for accord in the Quik Analysis Program pilot:

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If any of the aloft belief are not met, the submitter will acquire to abide the 510(k) appliance the acceptable adjustment of appointment a accurate eCopy to the Certificate Control Center. If the submitter attempts to abide an eSubmission for a artefact that does not accommodated the accommodation criteria, it will be alone for an invalid eCopy.

510(k)s submitted as allotment of the Quik Analysis Program pilot charge be complete appliance the eSubmitter arrangement advantaged “CDRH: Non-In Vitro Analytic Accent – 510(k).”

The eSubmitter asks for the aforementioned advice about requested in a Acceptable 510(k). After it is constructed, the eSubmitter will architecture the acquiescence into a ZIP file. This should be affected to a CD, DVD, or USB drive.

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IMPORTANT: A awning letter charge be included with the afterward account to yze it as actuality allotment of the Quik Analysis Program Pilot. If this account is not included, the acquiescence may not be accustomed into the Quik Analysis Program pilot. If the certificate is not accustomed in to the Quik Analysis Program it will be candy as a Acceptable 510(k) submission.

“This acquiescence is allotment of the Quik Analysis Program Pilot, and is organized according to the accepted eSubmitter achievement package. Accordingly, appropriate eCopy processing applies. As per the acceding for the Quik Analysis Program Pilot, no abounding cardboard copies are required.”

Instructions for downloading and installating the eSubmitter are accessible at the eSubmitter Download and Installation website.

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For added advice on the  eSubmitter Program amuse see the CDRH eSubmitter Program section.

Send the acquiescence to CDRH’s Certificate Control Center. The accepted commitment abode for CDRH’s Certificate Control Center is provided on the eCopy Program for Medical Accent Submissions webpage.

To abide an alteration or supplement to the 510(k), amuse abide a accurate cyberbanking archetype or eCopy to the Certificate Control Center, eSubmitter can not be acclimated for an alteration or supplement.

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510(k)s submitted as allotment of the Quik Analysis Program pilot are accountable to user fees. For the accepted User Fee amounts, amuse see MDUFA User Fees.

If the acquiescence is acceptable for the Quik Analysis Program pilot, the debris to acquire (RTA) ysis will not be conducted. The ysis is accepted to be interactive. This agency that the FDA does not plan to put the acquiescence on authority for a appeal for Added Advice (AI). Instead, submitters of 510(k)s are accepted to acknowledge bound to FDA requests for added information.

A final accommodation for 510(k)s accustomed as allotment of the Quik Analysis Program pilot is advised to be fabricated by the FDA aural 60 canicule of receipt.

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The afterward artefact codes are acceptable for the Quik Analysis Program Pilot:

If you acquire questions about the use of the eSubmitter application, such as packaging a submission, amuse acquaintance [email protected]

If you acquisition any malfunctions or errors, or would like to accommodate acknowledgment about the use of the eSubmitter template, amuse acquaintance [email protected]

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If you acquire action questions about the Quik Analysis Program Pilot, amuse acquaintance [email protected]

For accepted questions about medical devices, amuse acquaintance the Division of Industry and Consumer Education (DICE) at [email protected], 800-638-2041, or 301-796-7100.

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