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
2Subject of the guidance document; Subject of the reviewers guidance checklist
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
3Devices claiming this will not be reviewed by third parties
The standard for clearing a 510(k) device relative to a predicate.
Required data element for patient-centric and physician-centric devices
Identified Hazards
Hazards
1Risk due to heat generated during drilling through bone
Related CFR Sections (3)
- 21CFR888.3030§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a) Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that arRead full regulation →
- 21CFR888.3040§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a) Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straiRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
See Also (8)
- Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)
- Guidance for the Content of Premarket Notifications for Ureteral Stents (Status: Final)