Upon receipt in the Office, the k is assigned to the appropriate Division, and then assigned to a Lead Reviewer.
In the Acceptance Review , the Lead Reviewer determines whether the k submission meets the minimum threshold of acceptability and should be accepted for substantive review.
Within 15 days of the receipt of the submission, the submitter will receive an electronic notification of the Acceptance Review result, which will:. A k not accepted for review is placed on RTA Hold. The submitter has calendar days to fully address the deficiencies cited in the RTA Hold.
If this is not done, the k is considered withdrawn and deleted from our review system. If the k is deleted, the k submitter will need to submit a new, complete k to pursue FDA marketing clearance for that device. During Substantive Review , the Lead Reviewer conducts a comprehensive review of the k submission and communicates with the submitter through a Substantive Interaction , which should occur within 60 calendar days of receipt of the k submission.
The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as:. During Interactive Review , the Lead Reviewer may request additional information from the submitter, who may either send the information to the Lead Reviewer directly or to the DCC.
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In this one read more Get smart about the USA in 1 hour If you are thinking about entering the US market for the first time, understanding the FDA regulatory requirements can be overwhelming. Information read more. Have questions on what Emergo can do for you? With an understanding of the FDA pathways, you can better manage finances until you start generating revenue. The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a k application, or submit a Premarket Approval PMA application.
Bringing a medical device to market is not a fast process. Studies reveal it takes three to seven years in total from concept to approval, compared to an average of 12 years for drugs. The most effective way to predict speed-to-market is to evaluate the level of risk associated with your medical device and determine if it is a Class 1, 2, or 3 device. There are three possible pathways to market approval:.
Most Class 1 devices are exempt from the k clearance pathway, per the agency. The majority of devices that are already approved for sale fall under Class 1 and present the lowest risk to patients.
Class 1 devices include non-invasive items such as tongue depressors, oxygen masks, and electric toothbrushes. While a small percentage of Class 1 devices require a k submission, the majority can be self-registered with the agency.
This is a three-step process, explained in-depth on the FDA website.
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