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
6Third Party Review Guidance for Phacofragmentation System Device; The primary device subject to this 510(k) guidance.
Metered Dose Inhalers (MDI); Guidance focuses on in vitro testing for these specific drug delivery systems.
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators
Biological indicators are regulated as class II medical devices
multifunctional handpieces would convert the device to a combination device
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
1Allowed value for reporter qualification
Regulatory Context
Attributes
3support the use of the proposed cycle and the desired sterility assurance level
Specifications that are directly associated with the intended use of the device.
Regulatory 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.
Identified Hazards
Hazards
2Risk from heat generated by ultrasonic oscillation
Safety information required in the labeling
Related CFR Sections (4)
- 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 →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR886.4670§ 886.4670 Phacofragmentation system.
(a) Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.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 →
Related Warning Letters (9)
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
- 2023-10-31
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Samm Solutions, Inc., d.b.a. BTS Research
- 2022-08-09
Bioresearch Monitoring Program
Valley Biosystems
- 2022-02-22
Good Laboratory Practice (GLP)
Toxikon Corporation/Labcorp Bedford LLC
- 2020-05-05
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
University of Kentucky
- 2020-04-07
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Steiner Biotechnology, LLC
See Also (8)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (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)
- Testing Guidance for Male Condoms Made From New Material (Non-Latex) (Status: Final)
- Third Party Review Guidance For Vitreous Aspiration and Cutting Device Premarket Notification (510(k)) (Status: Final)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- 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)