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
4Subject of the guidance document
Devices for which the guidance is intended
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
General manual surgical instruments exempt from 510(k)
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1Determines the information to be submitted based on risks associated with software failure.
Identified Hazards
Hazards
2Required safety feature identification in device description; Required for software safety requirements
A risk factor (EMC) considered when adding an adapter.
Related CFR Sections (10)
- 21CFR890.1925§ 890.1925 Isokinetic testing and evaluation system.
(a) Identification. An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.Read full regulation →
- 21CFR890.5360§ 890.5360 Measuring exercise equipment.
(a) Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide Read full regulation →
- 21CFR890.5380§ 890.5380 Powered exercise equipment.
(a) Identification. Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a powered treadmill, a powered bicycle, and powered parallel bars.Read full regulation →
- 21CFR890.5410§ 890.5410 Powered finger exerciser.
(a) Identification. A powered finger exerciser is a device intended for medical purposes to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand.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 →
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR807.93§ 807.93 Content and format of a 510(k) statement.
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR890.5350§ 890.5350 Exercise component.
(a) Identification. An exercise component is a device that is used in conjunction with other forms of exercise and that is intended for medical purposes, such as to redevelope muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include weights, dumbbells, strRead full regulation →
- 21CFR890.5370§ 890.5370 Nonmeasuring exercise equipment.
(a) Identification. Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise taRead full regulation →
Related Warning Letters (5)
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-03-25
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Exer Labs, Inc.
- 2024-06-04
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device, Misbranded
Trexo Robotics Holdings Inc.
- 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)
- The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff (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)
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (Status: Final)
- CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers (Status: Final)
- CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3)*) (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Testing Guidance for Male Condoms Made From New Material (Non-Latex) (Status: Final)
- Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Status: Final)