FDA 510(k) Submission Process
Premarket Notification (510(k)) submissions for medical devices are reviewed via FDA’s middle for devices and Radiological health (CDRH), mainly by the office of Product evaluation and fine (OPEQ). There are 8 offices of fitness era (OHTs) inside OPEQ that are organized consistent with medical device specialties. 510(k) submissions are reviewed with the aid of OPEQ workforce, such as biomedical engineers, physicians, microbiologists, chemists, and other medical professionals.
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Log-in and Acknowledgement Procedure
A 510(k) submitter have to publish one electronic replica or eCopy of its 510(k) to CDRH’s or CBER’s file control center (DCC). The current mailing cope with for CDRH’s DCC and a link to CBER’s DCC’s mailing deal with are furnished on the eCopy application for medical device Submissions website.
while the DCC receives the 510(k) submission, it assigns the submission a unique manage range. This range is normally known as the “510(k) quantity,” or “k range.” The 510(k) quantity begins with the letter “k” accompanied by way of 6 digits. the primary digits designate the calendar year the submission was acquired; the ultimate four digits constitute the submission wide variety for the yr, starting with 0001 and increasing with every new submission.
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Acceptance Review
After the Acknowledgement Letter is despatched, the DCC routes the 510(k) to the ideal OHT, primarily based at the device type and medical distinctiveness this is indexed within the 510(k) submission.
Upon receipt within the office, the 510(k) is assigned to the right division, and then assigned to a Lead Reviewer. The Lead Reviewer conducts the recognition assessment using the perfect attractiveness tick list in FDA’s guidance titled Refuse to accept coverage for 510(k)s. within the recognition assessment, the Lead Reviewer determines whether the 510(k) submission meets the minimal threshold of acceptability and should be normal for important evaluation.
Read more – https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
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Substantive Review (including Substantive Interaction and Interactive Review)
- Interactive Review
- Additional Information (AI) Request
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510(k) Decision Letter
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Timeline of Communication with 510(k) Submitters
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