On November 30, 2023, the FDA announced in the Federal Register its intention to classify certain types of wound dressings that had remained unclassified as pre-amendment devices; i.e., devices that were in commercial distribution before enactment of the Medical Device Amendments of May 28, 1976.
The specific wound dressings the FDA is proposing to classify fall into the following three distinct categories:
- Solid wound dressings
- Wound dressings formulated as a gel, cream, or ointment
- Liquid wound washes, containing antimicrobials and/or other chemicals
Currently, these unclassified pre-amendment wound dressings require 510(k) clearance under the following product codes shown below. Also shown are the total number of 510(k)s cleared and the most recent 510(k) decision date for each of the existing pre-amendment product codes through December 1, 2023.
출처: Emergo by UL
FDA Announces Intent to Classify Certain Solid Wound Dressings | Emergo by UL
FDA Announces Intent to Classify Certain Solid Wound Dressings
On November 30, 2023, the FDA announced in the Federal Register its intention to classify certain types of wound dressings that had remained unclassified as pre-amendment devices; i.e., devices that were in commercial distribution before enactment of the M
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