Description
FDA is issuing this guidance document to describe the technical and scientific information that FDA expects in a marketing application for a pen, jet, or related injector device that is intended to be used with a drug or biological product.
Scope & Applicability
Product Classes
5Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
recommend that you perform additional testing
A device platform where penetration depth is a potential EDDO.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Injectors intended for use with a wide range of legally marketed drugs
Stakeholders
5Entity responsible for submitting NDINs
Assist sponsors in the nonclinical evaluation
User role with specific access privileges
Way questions are framed is critical to collecting unbiased patient input
It may be a hardship for patients and/or caregivers to attend in-person; Individuals who may assist patients or provide observations when patients cannot self-report.; conducted with caregivers to obtain similar feedback
Regulatory Context
Attributes
5Regulatory standard for 510(k) clearance; demonstration required for 510(k) submission; regulatory standard for 510(k) clearance; Comparison of subject device parameters to predicate 510(k) submission numbers.
Specified in the product label based on stability studies
intended storage conditions throughout the proposed shelf-life
Property of a device that may be changed via established protocols
analysis of lubricity breach of sealing
Identified Hazards
Hazards
4safety features to prevent injury
Risks resulting from misinterpreted abbreviations, poor legibility, or look-alike packaging.
automated liquid handling systems can pose a risk of contamination within or between test runs
Deleterious effect on fluid path due to high jet stream velocity
Related CFR Sections (12)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR208.20§ 208.20 Content and format of a Medication Guide.
(a) A Medication Guide shall meet all of the following conditions:Read full regulation →
- 21CFR880.5860§ 880.5860 Piston syringe.
(a) Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is usedRead full regulation →
- 21CFR880.6920§ 880.6920 Syringe needle introducer.
(a) Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.Read full regulation →
- 21CFR880.5430§ 880.5430 Nonelectrically powered fluid injector.
(a) Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be useRead full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR890.5050§ 890.5050 Daily activity assist device.
(a) Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.Read full regulation →
- 21CFR880.5440§ 880.5440 Intravascular administration set.
(a) Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line fRead full regulation →
- 21CFR872.4465§ 872.4465 Gas-powered jet injector.
(a) Identification. A gas-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a cartridge containing pressurized carbon dioxide which provides the pressure to force the anesthetic out of the syringe.Read full regulation →
- 21CFR872.4475§ 872.4475 Spring-powered jet injector.
(a) Identification. A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.Read full regulation →
- 21CFR3.4§ 3.4 Designated agency component.
(a) To designate the agency component with primary jurisdiction for the premarket review and regulation of a combination product, the agency shall determine the primary mode of action of the product. Where the primary mode of action is that of:Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
Related Warning Letters (1)
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
See Also (8)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)