Medical device risk (re)classification: lessons from the FDA's 515 Program Initiative
BMJ Surg Interv Health Technol
.
2023 Sep 28;5(1):e000186.
doi: 10.1136/bmjsit-2023-000186.
eCollection 2023.
Authors
Maryam Mooghali
1
,
Vinay K Rathi
2
,
Kushal T Kadakia
3
,
Joseph S Ross
1
,
Sanket S Dhruva
4
Affiliations
1
Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
2
Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Boston, Massachusetts, USA.
3
Harvard Medical School, Boston, Massachusetts, USA.
4
Medicine, University of California San Francisco School of Medicine, San Francisco, California, USA.
PMID:
38033980
PMCID:
PMC10687393
DOI:
10.1136/bmjsit-2023-000186
No abstract available
Keywords:
Device Safety; Health Policy.
Publication types
Review