Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Prescription Device 21 CFR 801.109
- A device which, because of any potentiality for harmful effect, or the supervision of the method of its use, or the collateral measures necessary to its use is not safe unless under a practitioner licensed by law to direct use this device, and hence for which "adequate directions for use" cannot be written, is exempt from such provided:
- - It is in the possession of either a licensed practitioner or persons lawfully engaged in the manufacture of distribution of the product;
- - Its labeling bears an Rx statement, i.e., "Caution: Federal law restricts this device to sale by or on the order of a (Insert name of physician, dentist or other licensed practitioner;"
- - Its labeling bears information for use including, indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which the device can safely be used; and
- - All labeling other than labels and carton bears the date of issuance or date of the latest revision.
Retail Exemption 21 CFR 801.110
- A device which is delivered to the ultimate user by a licensed practitioner in the course of their practice or upon prescription are required only to bear the name and address of the practitioner, directions for use, and any required cautionary statements.
Commonly Know Directions 21 CFR 801.116
- A device is exempt from adequate directions for use if adequate directions for common uses are known to the ordinary individual.
In Vitro Diagnostics 21 CFR 801.119
- Are exempt from adequate directions for use provided that they meet those requirements found in 21 CFR 809.10(covered in the "In Vitro Diagnostic Product Labeling" section this chapter).
Medical Devices Used in Manufacturing 21 CFR 801.122
- Devices used for processing, repacking, or manufacturing of another drug or device are exempt from adequate directions for use if they bear the statement: "Caution: For manufacturing, processing, or repacking."
Medical Devices Used in Teaching, Research, or Law Enforcement 21 CFR 801.125
- Devices for use in teaching, law enforcement, research, and analysis are exempt if the device is shipped or sold to, or in the possession of, persons lawfully engaged in instruction in pharmacy, chemistry, or medicine (not involving clinical use), law enforcement, or chemical analysis or physical testing.
Expiration of Exemptions 21 CFR 801.127
- Exemptions from adequate directions for use are terminated:
- - If devices are shipped to individuals other than those who are listed as exempt, or
- - If the devices are used for other than the exempted purposes.