U.S. Food and Drug Administration

FDA · United States · north america

Regulatory jurisdiction profileJurisdictional reference

Medical device clearednational regulator

First regulator in the world to clear medicinal leeches as a medical device — Hirudo medicinalis cleared under K040187 (June 21 2004).

Regulatory Profile

Agency type: national regulator
Region: north america
Country: United States
Leech status: medical device cleared
Last ASH review: 2026-05-25
Website: https://www.fda.gov

Relevant Regulation Codes

510(k) K040187 (Ricarimpex SAS, June 21 2004)
21 CFR Part 820 / QMSR (Quality Management System Regulation)
21 CFR Part 807 (Establishment Registration & Device Listing)
21 CFR Part 803 (Medical Device Reporting / MDR)
21 U.S.C. § 360c (Device classification — Unclassified Pre-Amendment, NRN product code)

Prescriber Requirements

Prescription device — order required from a licensed practitioner (MD, DO, DPM, DDS, NP, PA per state scope)
Application may be delegated to RN / LPN / wound-care nurse under physician supervision
No federal certification required for the applicator; institutional credentialing is hospital-policy driven

Supply Chain & GMP

Sole U.S.-cleared supplier historically Ricarimpex SAS (France); domestic distributors must register as initial importers under 21 CFR Part 807 and follow MDR adverse-event reporting. Cold-chain storage 4–10 °C in dechlorinated water with monthly water changes per manufacturer IFU.

Import/Export Rules

Import of live Hirudo medicinalis requires (i) FDA prior notice under 21 CFR Part 1, (ii) USDA / APHIS veterinary import permit (live invertebrate), and (iii) USFWS clearance under CITES Appendix II for Hirudo medicinalis / verbana. Each shipment must reference the K040187 510(k) number.

Reimbursement Context

Medicare Part A bundles leech therapy into the inpatient DRG (no separate procedure code). Medicare Part B has no dedicated HCPCS code — providers bill under CPT 97597/97602 (wound debridement) or unlisted procedure codes. Most commercial payers follow Medicare; coverage for venous-congestion salvage in reconstructive surgery is rarely denied when documented as medically necessary.

Key Regulatory Documents

ASH Editorial Notes

Important: leeches are classified as Unclassified Pre-Amendment under product code NRN — they were NOT given a 21 CFR 880.xxxx device-specific regulation number (the previously cited 880.5475 is incorrect; corrected per ASH FDA baseline 2026-05-21). They were the SECOND living organism FDA-cleared, after maggots (Jan 2004). K033704 is the maggot file, not the leech file.

Related Jurisdictions

Health Canada — Canada

Regulates Hirudo medicinalis under the Medical Devices Regulations as a Class II device; mirrors FDA risk classification with bilingual labelling requirements.

COFEPRIS — Mexico

Mexico's federal health-risk authority — leech therapy regulated as a medical device under General Health Law, with traditional-medicine carve-outs at state level.

MHRA — United Kingdom

Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).

ANSM — France

Home regulator of Ricarimpex SAS — the world's only leech manufacturer simultaneously CE-marked and FDA-cleared, operating under ANSM oversight since 1845.

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