Table 7.

Publication of Objective Regulatory Guidance Outcome = Approval Time

	(1)	(2)	(3)	(4)
Post-Guidance	−10.0515**	−8.3711†	(4.7666)	(4.9293)
ATE (Post-Guideance)			−6.0696*** (0.8577)
ATT (Post-Guideance)				−8.5193*** (3.0972)
Controls	X	X	X	X
Excluding first 2 Entrants		X
Pre-Post Analysis	X	X
Matched Analysis			X	X
N	64	51	192	192
R2	0.3401	0.3944

^†p<0.10

^*p<0.05,

^**p<0.01,

^***p<0.001

This table shows the covariate-controlled results of a regression model of the relationship between new device approval times and the publication of regulatory guidance for the four cases presented in Table 8.

All models include product code fixed effects and controls for whether a product was granted “priority” (expedited) review, application year, and a count of the applicant firm’s approved applications at the time of submission. Columns 1 and 2 present results from a pre-post analysis of guidance publication. Column 1 shows results for all devices in affected categories. Column 2 excludes the first entrants so as not to bias the results by including a group that is known to have longer approval times in the pre-guidance average.

Columns 3 & 4 presents results from a “nearest neighbor” matching analysis in which each device in a “treated” product code is matched to two other “untreated” devices based on observables including entry order, submission year, submissions in the product code at the time of a given application, and average approval times in the product code. Both the average treatment effect (ATE) and average treatment effect on the treated (ATT) from this analysis are presented.