Description
The Food and Drug Administration (FDA) is issuing this guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths.
Scope & Applicability
Product Classes
5Primary device category covered by the guidance; Devices subject to reclassification and labeling recommendations
Primary device category covered by the guidance; Devices requiring technical characteristics on package labels
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Class II devices assigned the product code NAY
The primary device category covered by this guidance.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
4Technical characteristic used to identify staple specifications
Key performance parameter for determining staple compatibility.
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Technical characteristic identifying open and closed dimensions
Identified Hazards
Hazards
5Commonly reported problem in adverse event reports
Commonly reported problem in adverse event reports
Device malfunction that requires mitigation instructions in labeling.
Risk associated with firing over an obstruction.
Risk specifically associated with the crossing of staple lines.
Related CFR Sections (4)
- 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 →
- 21CFR878.4740§ 878.4740 Surgical stapler.
(a) Surgical stapler for external use.Read full regulation →
- 21CFR878.4750§ 878.4750 Implantable staple.
(a) Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.Read full regulation →
- 21CFR876.1500§ 876.1500 Endoscope and accessories.
(a) Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optRead full regulation →
Related Warning Letters (2)
- 2023-06-06
Medical Devices/Adulterated/Quality System Regulation (QSR)
iRhythm Technologies, Inc.
- 2020-04-21
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Tenderneeds Fertility LLC
See Also (8)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Status: Final)
- Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] (Status: Final)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- CPG Sec. 335.300 Hypnotherapy Devices - Self-Hypnotic Tape Recordings (Status: Final)