Table 2.

Types of PMA supplement review tracks

Supplement Review Track	Description
180-day track	Formally introduced in 1986
	Reviewed by FDA staff or, in some cases, expert panel
	Requires preclinical data and, in some cases, clinical data
	Intended for design and labeling changes affecting safety and efficacy, eg, approval of new acetabular shell to be used with ceramic liner in hip prosthesis
Special track	Formally introduced in 1986
	Reviewed by FDA staff
	Requires no specific new data
	Intended for labeling changes meant to enhance device safety, eg, revisions to patient and physician labeling or surgical technique manual
Panel track	Formally introduced in 1990
	Reviewed by subject matter expert panel
	Requires substantial new clinical data in most cases
	Intended for labeling changes expanding indications for use or removing contraindications, eg, expanded indications for intervertebral body fusion device for one- or two- level fusions
Real-time process	Formally introduced in 1997
	Reviewed by FDA staff
	Requires preclinical data
	Intended for minor changes in design, software, or labeling, eg, addition of a tamp extractor instrument to a total hip prosthesis system
30-day notice	Formally introduced in 1997
	Reviewed by FDA staff
	Requires no specific new data
	Intended for changes in manufacturing processes that may affect device safety and efficacy, eg, change in component supplier or sterilization testing procedure
135-day review	Formally introduced in 1997
	Reviewed by FDA staff
	Requires new information per FDA request
	Intended for 30-day notice applications requiring further review before clearance, eg, change in polishing process and equipment for total hip prosthesis system