I can see why this debate started - the September 2019 guidance for Abbreviated 510(k)s does not include any mention of the need to reference a predicate device (indeed, the word 'predicate' does not occur anywhere in the guidance!), although it does state:
"An Abbreviated 510(k) submission must include the required information identified in 21 CFR 807.87." You can be sure, however, that FDA will issue an RTA for any Abbreviated 510(k) that does not include a predicate device (see Section C.15.a. of the Abbreviated 510(k)
RTA checklist).
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 22-Oct-2020 07:14
From: Lee Leichter
Subject: Abbreviated 510(k) question
Predicates are required element of the 510(k) process and necessary to establish that the proposed product has the same intended use and classification so as to be considered for a 510(k). Otherwise, it is a PMA or needs to go through the De Novo classification process. "Abbreviated", along with Traditional and Special, are only the options available to provide the "supporting" data to FDA to make a Substantially Equivalent determination.
Lee Leichter
President
P/L Biomedical
10882 Stonington Avenue
Fort Myers, FL 33913 USA
Office: +1-239-244-1448
Cell: +1-239-994-6488
Email: leichter@plbiomedical.com
Original Message:
Sent: 10/20/2020 8:17:00 PM
From: Anonymous Member
Subject: Abbreviated 510(k) question
This message was posted by a user wishing to remain anonymous
We have an ongoing debate. One party in the debate believes that a predicate device is not required for an Abbreviated 510(k). The other party believes that a predicate device is required.
Both parties read the various guidance documents and regulations. The difference is in the interpretation of what the guidance says.
Any thoughts?
Thanks