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Know about the FDA 510k Submission

Traditional, Special, and Abbreviated Premarket Notification 510(k)s may be filed to the FDA. Special and Abbreviated 510(k) Programs were formed by the FDA in 1998 to expedite the examination of specific kinds of FDA 510 k Submission. The New 510(k) Paradigm guideline has previously outlined these programs. Read https://www.bloglovin.com/@biotechresearchgroup/know-about-fda-510k-submission<br><br>

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Know about the FDA 510k Submission

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  1. Know about the FDA 510 k Submission Traditional, Special, and Abbreviated Premarket Notification 510(k)s may be filed to the FDA. Special and Abbreviated 510(k) Programs were formed by the FDA in 1998 to expedite the examination of specific kinds of FDA 510 k Submission. The New 510(k) Paradigm guideline has previously outlined these programs. There are now two independent guidance papers for the 510(k) process: the Special 510(k) Program and the Abbreviated 510(k) Program. 510(k) submissions that satisfy specified criteria may be submitted as Special 510(k) or Abbreviated 510(k) submissions. To get marketing permission for a device, the 510(k) Program may be employed in any situation. The form details There is no "form" to fill out for a Premarket Notification 510(k). Information needed by 21 CFR

  2. 807.87 is included in a 510(k) submission. Substantial Equivalence (SE) to a lawfully marketed device, often known as a predicate, is the basis for all FDA 510 k Submission. In all 510(k) submissions, the predicate device or devices are compared to the product or devices that will be marketed. Look for an Identifiable Predicate Your 510(k) submission should be based on a principal predicate device that is the most comparable to your product in terms of usage and technical attributes. You may be able to claim SE to more than one predicate in certain situations. Predicate devices should be recognized by their 510(k) numbers, according to our recommendation. For further information, see Finding and Using Predicate Devices Effectively. Find Helpful Documents There's a lot of information on the FDA's 510(k) review procedure included in the FDA's guideline document.

  3. Significant Equivalence in Premarket Notification: The FDA 510 k Submission Program's Evaluation [510(k)]. The Food and Drug Administration (FDA) publishes guidance papers to convey its suggestions to businesses. The Guidance Documents page has all of these documents. The FDA's examination of a 510(k) submission for a certain kind of device may be facilitated by device- specific guidance materials. At the beginning of the device planning process, we suggest consulting device- specific advice manuals. Additional consideration should be given to the Quality System regulation's design control requirements (21 CFR 820.30). Where to Send a 510 Form (k)? It is necessary to file a 510(k) in electronic form (eCopy). The FDA does not return a 510(k) submission or any copies thereof after it has been received by the FDA. It is important to keep a copy of your 510(k). CDRH's or CBER's Document Control Center should receive your medical device submission package (DCC).

  4. Source: https://www.bloglovin.com/@biotechresearchgroup/ know-about-fda-510k-submission

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