Description
On February 11, 1980, *the Bureau of Radiological Health (BRH), now the Center for Devices and Radiological Health (CDRH)* wrote to all manufacturers and potential manufacturers of these lamps that the following warning statement is required in advertisements for high-intensity mercury vapor discharge lamps which are not self-extinguishing: "WARNING: This lamp can cause serious skin burns and eye inflammation from shortwave ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more than a few minutes unless adequate shielding or other safety precautions are used. Lamps that will automatically extinguish when the outer envelope is broken or punctured are commercially available."
Scope & Applicability
Product Classes
5Third Party Review Guidance for Phacofragmentation System Device; The primary device subject to this 510(k) guidance.
Biological indicators are regulated as class II medical devices
The primary device type discussed in the guidance.; Device type subject to the review checklist
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
3Standard for 510(k) clearance
Evidence of a new intended use based on communications
support the use of the proposed cycle and the desired sterility assurance level
Identified Hazards
Hazards
4Risk from heat generated by ultrasonic oscillation
Safety information required in the labeling
Risk of febrile reaction
Risk caused by excessive vacuum build up
Related CFR Sections (5)
- 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 →
- 21CFR1040.30§ 1040.30 High-intensity mercury vapor discharge lamps.
(a) Applicability. The provisions of this section apply to any high-intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and is manufactured or assembled after March 7, 1980, except as described in paragraph (d)(1)(ii) of this section.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 →
See Also (8)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (Status: Final)
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (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)