CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR880.5210]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart F - General Hospital and Personal Use Therapeutic Devices

Sec. 880.5210 Intravascular catheter securement device.

(a) Identification. An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001]