The FDA classification record describes disinfected fly larvae for debridement of specified non-healing necrotic skin and soft-tissue wounds. Read the definition and product-code information in the original record.
This is a category-level source. It does not establish that every seller using similar words is authorized, or that a specific product is suitable for a particular person.
Open FDA classificationFDA documents the transfer of regulatory responsibility for medical maggots and medicinal leeches from CDRH to CBER, effective December 30, 2024. Use that notice to understand the responsible center and the referenced records.
An administrative change does not, by itself, add a new clinical indication or establish a treatment benefit. Read the product-specific documentation when the question concerns a named item.
Open FDA notice1. Identity: write the exact product name and applicant or manufacturer. A general treatment name is not a unique identifier.
2. Identifier: copy the record number. This allows another reader to verify that you are discussing the same entry.
3. Date: distinguish the decision or document date from the date on which you accessed it. A recently accessed record may describe a much older decision.
4. Purpose: preserve the source’s actual indication or intended-use language. Do not replace a narrower purpose with a broader healing claim.
5. Limits: identify the jurisdiction, source type and questions that the record does not address. Keep current availability and professional assessment separate.
Describe an FDA record using its own terminology. A product-specific clearance, a classification and a manufacturer’s assertion should not all be shortened to “FDA approved.” When the source does not establish a statement, mark it as unresolved rather than adding an official-sounding label.
A clinician considering treatment also needs to assess evidence, the care setting, the patient and alternatives. A regulatory source cannot substitute for that process. Likewise, a positive study result does not establish every product’s legal status.
The two FDA sources above were consulted on 28 September 2026. This page is manually curated; it does not synchronize with FDA or certify current legal status. For a detailed reading path, see How to read an MDT regulatory record.
