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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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Medical Device and FDA Regulations and Standards News
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FDA News
FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard
Mark Meer
Oct 14, 2020
Replies
0
Views
537
Oct 14, 2020
Mark Meer
M
FDA News
USFDA Proposes to End Temporary Extension of GUDID’s Grace Period
Marcelo
Dec 19, 2018
Replies
3
Views
704
Aug 6, 2019
ConA2019
FDA News
FDA's CDRH is silo-ing along product lines - CDRH Reorganization
Ronen E
May 1, 2019
Replies
4
Views
496
May 3, 2019
Ronen E
M
FDA News
USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements
Marcelo
Feb 8, 2019
Replies
0
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615
Feb 8, 2019
Marcelo
M
FDA News
USFDA – Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) – Letter to Health Care Providers
Marcelo
Feb 7, 2019
Replies
0
Views
493
Feb 7, 2019
Marcelo
M
FDA News
USFDA draft guidance – Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability
Marcelo
Feb 6, 2019
Replies
0
Views
415
Feb 6, 2019
Marcelo
M
FDA News
FDA Recognizes 138 Consensus Standards
Marcelo
Jan 29, 2019
Replies
0
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286
Jan 29, 2019
Marcelo
M
FDA News
USFDA – Safety and Performance Based Pathway Guidance
Marcelo
Jan 22, 2019
Replies
0
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457
Jan 22, 2019
Marcelo
M
FDA News
USFDA Digital Health Update – New actions and documents
Marcelo
Jan 8, 2019
Replies
0
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331
Jan 8, 2019
Marcelo
M
FDA News
Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation
Marcelo
Dec 21, 2018
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0
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377
Dec 21, 2018
Marcelo
M
FDA News
USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management
Marcelo
Dec 21, 2018
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0
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379
Dec 21, 2018
Marcelo
M
FDA News
Statement from USFDA on steps to strengthen the long-term safety oversight of the Essure device
Marcelo
Dec 21, 2018
Replies
0
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329
Dec 21, 2018
Marcelo
M
FDA News
USFDA – Reclassification of Electroconvulsive Therapy Devices
Marcelo
Dec 21, 2018
Replies
0
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258
Dec 21, 2018
Marcelo
M
FDA News
USFDA – Announcement of Safer Technologies Program (STeP)
Marcelo
Dec 19, 2018
Replies
0
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488
Dec 19, 2018
Marcelo
M
FDA News
USFDA – Breakthrough Devices Program final guidance
Marcelo
Dec 19, 2018
Replies
0
Views
307
Dec 19, 2018
Marcelo
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