Description
Thisguideprovides: Criteria for Considering an Investigational Medical Laser Device as a Significant Risk Device
Scope & Applicability
Product Classes
3Higher power versions may be considered significant risk devices depending on emission and application.
Laser products generally considered significant risk devices.
Devices requiring full IDE submission
Stakeholders
3Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Entity responsible for submitting applications under section 524B
Governs top dose in clinical studies
Regulatory Context
Attributes
1Regulatory status for products similar to a predicate
Related CFR Sections (1)
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
Related Warning Letters (5)
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-12
Investigational Review Board (IRB)
Nobles Medical Technology II, Inc.
- 2023-04-04
CGMP/QSR/Medical Devices/Adulterated
Synovo Production, Inc.
- 2020-04-07
Investigational Device Exemptions (Clinical Investigator)
Kennedy, Philip R.
See Also (8)
- Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry (Status: Final)
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)
- Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff (Status: Final)
- Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Tonometers - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff (Status: Final)