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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR878.4685]
See Related Information on Extracorporeal shock wave device for treatment of chronic wounds. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES

Subpart E - Surgical Devices

Sec. 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.

(a) Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.

(4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.

(7) Physician labeling must include:

(i) Information on how the device operates and the typical course of treatment;

(ii) A detailed summary of the device's technical parameters;

(iii) Validated methods and instructions for reprocessing of any reusable components; and

(iv) Instructions for preventing hearing loss by use of hearing protection.

(8) Patient labeling must include:

(i) Relevant contraindications, warnings, precautions, adverse effects, and complications;

(ii) Information on how the device operates and the typical course of treatment;

(iii) The probable risks and benefits associated with the use of the device;

(iv) Post-procedure care instructions; and

(v) Alternative treatments.

[83 FR 9699, Mar. 7, 2018]

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