Table 1

Characteristics of novel high-risk therapeutic device types receiving initial FDA premarket approval with subsequent intraclass competition, 2001–2021

No of device types (%)
All40 (100.0)
 Cardiovascular20 (50.0)
 Orthopedic5 (12.5)
 Ophthalmic4 (10.0)
 Genitourinary3 (7.5)
 Neurological3 (7.5)
 All other5 (12.5)
 Yes31 (77.5)
 No9 (22.5)
 Yes17 (42.5)
 No23 (57.5)
Initial approval year
 2001–200925 (62.5)
 2010–201815 (37.5)
Expedited review*
 First-in-class18 (45.0)
 Second-in-class or third-in-class7 (11.9)
Approved for pediatric use†
 Yes2 (5.0)
 No38 (95.0)
Median (IQR)
No of competing manufacturers2.0 (2.0–3.25)
FDA review time (months)
 First-in-class14.2 (9.1–22.1)
 Second-in-class10.6 (7.6–17.1)
 Third-in-class‡13.9 (11.0–16.0)
Time to competitor device FDA approval (months)
 Second-in-class25.6 (5.9–78.6)
 Third-in-class‡56.2 (33.1–86.1)
  • *The FDA granted expedited review for medical devices with the potential to significantly improve the prevention, diagnosis or treatment of serious conditions through several pathways during the study period, including the Innovation Pathway (2011–2014), Priority Review Program (2012–2016), Expedited Access Pathway (2015–2016) and Breakthrough Devices Program (2016–present).

  • †Proportion determined based on original FDA-approved indication; additional indications may be approved via supplemental applications.

  • ‡Among device types with at least 2 approved competitor devices (n=20).

  • FDA, Food and Drug Administration.