Description
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological HealthOffice of Device Evaluation
Scope & Applicability
Product Classes
8Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
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.
Medical devices used for contraception and protection from STDs/HIV.; The guidance focuses on the surveillance and detention of condoms offered for import.; subject of surveillance and detention
cleared to remove tissue and fluid from the body
Radiofrequency devices in urology
General indication for use- Provide access to vasculature
General indication for use- Cut, coagulate soft tissue
General indication for use-Skin resurfacing
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
3Evidence of a new intended use based on communications
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.
Not Substantially Equivalent finding
Identified Hazards
Hazards
1risk from removal of large quantities of body fat
Related CFR Sections (1)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
Related Warning Letters (10)
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-07-15
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WHOOP, Inc.
- 2025-05-27
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
DRG Instruments GmbH
- 2025-03-25
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Rex Implants Inc.
- 2024-09-10
CGMP/QSR/Medical Devices/Adulterated
Optikem International, Inc.
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Shenzhen Moyeah Intelligent Life Technology Co.
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Adventure Innovations LLC
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Natures Pillows, Inc. and Top Dog Direct, LLC
- 2024-08-13
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Baylab USA, LLC
See Also (8)
- Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- 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)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes (Status: Final)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (Status: Final)