Transitional Device

Transitional devices are devices that were regulated by FDA as new drugs before May 28, 1976. Any Class III device that was approved by a New Drug Application (NDA) is now governed by the PMA regulations. The approval numbers for these devices begin with the letter N. These devices are identified in the CFR as Class III devices and state that an approval under section 515 of the Act (PMA) is required as of May 28, 1976 before this device may be commercially distributed. An example of such device is intraocular lenses (21 CFR 886.3600). Please note that some of the transitional devices have been subsequently down classified to Class II.

Some of the transitional devices were classified as:

• Gauze
• Adhesive Tape
• Tampons
• Dialysis Fluid
• Denture Cushions

Others remain in Class III

• Injectable Silicone
• Adsorbable Sutures (some reclassified into class II)
• Adsorbable Dusting Powders
• Injectable Teflon
• Soft Contact Lenses (reclassified into Class II)

Absorbable powder for lubricating a surgeon’s glove is a transitional device (42 FR 63472, Dec. 16, 1977). Before the enactment of the Amendments, an approved New Drug Application (NDA) was required for absorbable powder for lubricating a surgeon’s glove (then known as desiccant and lubricant powder for surgical gloves). On June 24, 1988, FDA codified the statutory class III classification of absorbable powder for lubricating a surgeon's glove (21 CFR § 878.4480) (53 FR 23875).

Exempted investigations: This part, with the exception of 812.119, does not apply to investigations of the following categories of devices:

(1) A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time.

(2) A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.