Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff | Guideline Explorer

Description

Thisguidance documentaddresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance document is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of coating-related information across these product areas, as well as to promote the safe use of these devices in the clinical setting. Medical devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems are commonly used during minimally invasive diagnostic and therapeutic procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems. These devices often have hydrophilic and/or hydrophobic lubricious coatings (e.g., polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone) to reduce friction between devices, and between device(s) and blood vessels. It is commonly believed that these coatings may offer physicians greater maneuverability and may result in less trauma to blood vessels for patients.

Scope & Applicability

Product Classes

2

Class II Device

Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders

Class III Device

Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.

Stakeholders

1

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Attributes

1

Expiration Date

Property of a device that may be changed via established protocols

Identified Hazards

Hazards

2

Coating Damage

result of size mismatch or improper manipulation

Coating Separation

serious adverse events associated with hydrophilic and/or hydrophobic coatings separating; multifactorial cause of serious injuries

Related CFR Sections (4)

21CFR870.1330§ 870.1330 Catheter guide wire.
(a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.Read full regulation →
21CFR870.1200§ 870.1200 Diagnostic intravascular catheter.
(a) Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among otheRead full regulation →
21CFR801.18§ 801.18 Format of dates provided on a medical device label.
(a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month,Read full regulation →
21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

Related Warning Letters (2)

Medical Devices/Adulterated/Quality System Regulation (QSR)
iRhythm Technologies, Inc.
2023-06-06
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Tenderneeds Fertility LLC
2020-04-21