Scope & Applicability
Product Classes
6Devices including wristlets, anklets, vests, and body holders intended for medical purposes
Classification regulation revised alongside protective restraints
Considered Tier 2 devices requiring focussed scientific review
General manual surgical instruments exempt from 510(k)
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Common name for devices in Class I, Panel 80; The guidance covers premarket notification submissions for protective restraints.; The device type covered by this guidance document
Stakeholders
6Entity responsible for submitting NDINs
discussed potential liver toxicity of ximelagatran in September 2004
Nurses, aides, and technicians who typically use the device.
Entity responsible for submitting NDINs
Must comply with registration if meeting facility/responsible person definitions
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
3Evidence of a new intended use based on communications
Durability of the device and attached labels must be specified.
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
4Injury and death risk associated with protective restraints
Pictorial and written warnings about misapplication hazards
Prevalence of injuries may vary between institutions.
Identified risk to health for surgical masks.
Related CFR Sections (5)
- 21CFR890.3910§ 890.3910 Wheelchair accessory.
(a) Identification. A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapRead full regulation →
- 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 →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR801.4§ 801.4 Meaning of intended uses.
The words intended uses or words of similar import in §§ 801.5 , 801.119 , 801.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the designRead full regulation →
- 21CFR880.6760§ 880.6760 Protective restraint.
(a) Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examinaRead 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)
- 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)
- 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)
- 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)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)