2024-19722. Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression
Table 1—External Compression Device for Internal Jugular Vein Compression Risks and Mitigation Measures
Identified risks to health Mitigation measures Syncope due to excessive compression Non-clinical performance testing. Use error, interference with other equipment, or ineffective treatment leading to impact-related trauma or injury Human factors testing, and Labeling. Adverse tissue reaction Biocompatibility evaluation.
Document Information
- Effective Date:
- 9/3/2024
- Published:
- 09/03/2024
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final amendment; final order.
- Document Number:
- 2024-19722
- Dates:
- This order is effective September 3, 2024. The classification was applicable on February 26, 2021.
- Pages:
- 71159-71160 (2 pages)
- Docket Numbers:
- Docket No. FDA-2024-N-3946
- Topics:
- Medical devices
- PDF File:
- 2024-19722.pdf
- CFR: (1)
- 21 CFR 890