Hello Will,
FDA has done this a few times before when re-classifying devices which are related to more specific indications, related to type of technology, evolution of technology, or a specific device type. The wording is a bit confusing, a bit of legal jargon in there, which in my experience goes back to the indications for use/intended use as it relates to the regulation. A first issue is Product Code FRO is one of those "kitchen sink codes" where there were so many different product types under this one Product Code. They have been parsing out some of the codes to make them more specific. The wording about 'accept a new 510(k)' has to do with the current product's 510(k) clearance and how it relates to the new re-classification and how it meets the Special Controls which are defined. Probably the most significant issue for new products in the future which would be under a new Product Code would/could potentially not be able to use a predicate device which was cleared under Product Code FRO.
So your statement is a bit correct, only devices cleared under the new classification/Product Code could be used as predicates for future devices. Also importantly, if you have an existing device cleared under the existing Product Code FRO - whatever the new Special Controls are defined, such as biocompatibility testing, shelf life, labelling, or even clinical data these would need to be on file or available for the existing devices. The last sentence can happen if there are Special Controls for information being added such as labelling for which the company does not update, then they are not compliant.
If there is some concern about your device, where it falls under the re-classification, it might be beneficial to have a Q-Submission meeting with the division to understand any impact to performance or clinical testing which you may have.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 12-Jan-2024 09:59
From: William Coulston
Subject: Reclassification of FRO Medical Devices
Colleagues,
I am hoping to get your opinion on the upcoming reclassification of General and Plastic Surgery Devices specifically, classification of certain solid wound dressings; wound dressings formulated as a gel, creams, or ointment; and liquid wound washes. See Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Proposed Rules for the proposed rule.
It seems to state that CDRH will require previously cleared devices to submit new 510(k) and only those newly cleared devices will be used as predicates in the future. Here is a cut/paste from the section of the proposed rule:
" Devices proposed to be classified into class II that have prior 510(k) clearance: FDA proposes that it would accept a new 510(k) and would issue a new clearance letter, as appropriate, indicating substantial equivalence and compliance with the special controls. These devices could serve as predicates for new devices." Later it says, " FDA proposes that if a manufacturer markets such a device 6 months after the effective date of the rule, when finalized, and that device does not comply with the special controls, then FDA would consider taking action against such a manufacturer under its usual enforcement policies."
Am I reading too much into this? What approach would you take to rebut this effort?
Curious to see what y'all think.
Warmest Regards,
will
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William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
Rochal Technologies
San Antonio TX
United States
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