Description
This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.
Scope & Applicability
Product Classes
3The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Classification name for the device
Subject of the 510(k) checklist for use with transurethral surgical instruments
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1support the use of the proposed cycle and the desired sterility assurance level
Related CFR Sections (2)
- 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 →
- 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)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (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)