Regulatory strategies for early device development and approval-Reference-Cited by-同舟云学术

Regulatory strategies for early device development and approval

Published:2022-04-29 Issue:6 Volume:99 Page:1784-1788
ISSN:1522-1946
Container-title:Catheterization and Cardiovascular Interventions
language:en
Short-container-title:Cathet Cardio Intervent

Author:

Holmes David R.¹^ORCID,Geoffrion Rick²,Hunt Jon³,Hance Robert ”Chip”⁴,Leon Martin B.⁵,Mack Michael J.⁶,Kaplan Aaron V.⁷

Affiliation:

1. Mayo Clinic Rochester Minnesota USA

2. Cyrano Therapeutics Delray Beach Florida USA

3. HeartBeam Inc Santa Clara California USA

4. Regatta Medical Bannockburn Illinois USA

5. Department of Medicine, Columbia University Medical Center and Center for Interventional Vascular Therapy Columbia University New York New York USA

6. Department of Cardiovascular Surgery Baylor Health Care System, and Baylor Scott and White The Heart Hospital—Plano Research Center Plano Texas USA

7. Dartmouth‐Hitchcock Medical Center Lebanon New Hampshire USA

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/ccd.30151

Reference17 articles.

1. Food and Drug Administration Center for Biologics and Research. Investigational device exemptions (IDEs) for early feasibility medical device clinical studies including certain first in human (FIH) studies: guidance for industry and Food and Drug Administration staff. October 1 2013.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-device-exemptions-ides-early-feasibility-medical-device-clinical-studies-including

2. 21st Century Cures Act Pub.L.114‐255.2016. https://www.congress.gov/bill/114th‐congress/house‐bill/34

3. Med Device OnlineMedical device innovation consortium releases first‐of‐its‐kind patient preference framework. May 13 2015

4. US Food and Drug Administration. Program for parallel review of medical devices. October 24 2016.https://www.federalregister.gov/documents/2016/10/24/2016‐25659/program‐for‐parallel‐review‐of‐medical‐devices

5. US Food and Drug Administration Drug. 21st Century Cures Act. Accessed March 29 2018.https://www.fda.gov/regulatory‐information/selected‐amendments‐fdc‐act/21st‐century‐cures‐act

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1. From bench to bedside: A narrative review and institutional experience with experimental models for vascular device design and translation;Seminars in Vascular Surgery;2022-12