FDA Medical Device Approval: Things You Didn't Learn in Medical School or Residency

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Article
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Thu, 09/19/2019 - 14:15
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FDA Medical Device Approval: Things You Didn't Learn in Medical School or Residency
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Buch B

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036080407.pdf
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Barbara Buch, MD

Dr. Buch is Deputy Director with the Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland.

Issue
The American Journal of Orthopedics - 36(8)
Publications
The American Journal of Orthopedics
MDedge Surgery
Topics
Practice Management
Business of Medicine
Orthopedics
Page Number
407-412
Legacy Keywords
FDA, food and drug administration, medical device, approval, food and drug administration, off-label use, on-label use, regulatory, Health and Human Services, HHS, Center for Devices and Radiological Health, market, clearance, legal, marketing, medical device reporting, MDR, premarket approval, PMA, 510k, clearance, investigational device exemptions, IDE, investigational new drug application, IND, health care, ajo, american journal of orthopedics
Sections
Clinical Review
Author(s)
Buch B
Author(s)
Buch B
Author and Disclosure Information

Barbara Buch, MD

Dr. Buch is Deputy Director with the Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland.

Author and Disclosure Information

Barbara Buch, MD

Dr. Buch is Deputy Director with the Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland.

Article PDF
036080407.pdf
Article PDF
036080407.pdf

Issue
The American Journal of Orthopedics - 36(8)
Issue
The American Journal of Orthopedics - 36(8)
Page Number
407-412
Page Number
407-412
Publications
The American Journal of Orthopedics
MDedge Surgery
Publications
The American Journal of Orthopedics
MDedge Surgery
Topics
Practice Management
Business of Medicine
Orthopedics
Article Type
Article
Display Headline
FDA Medical Device Approval: Things You Didn't Learn in Medical School or Residency
Display Headline
FDA Medical Device Approval: Things You Didn't Learn in Medical School or Residency
Legacy Keywords
FDA, food and drug administration, medical device, approval, food and drug administration, off-label use, on-label use, regulatory, Health and Human Services, HHS, Center for Devices and Radiological Health, market, clearance, legal, marketing, medical device reporting, MDR, premarket approval, PMA, 510k, clearance, investigational device exemptions, IDE, investigational new drug application, IND, health care, ajo, american journal of orthopedics
Legacy Keywords
FDA, food and drug administration, medical device, approval, food and drug administration, off-label use, on-label use, regulatory, Health and Human Services, HHS, Center for Devices and Radiological Health, market, clearance, legal, marketing, medical device reporting, MDR, premarket approval, PMA, 510k, clearance, investigational device exemptions, IDE, investigational new drug application, IND, health care, ajo, american journal of orthopedics
Sections
Clinical Review
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