Tag: Investigational device exemption

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Recent Related Articles to Investigational device exemption

FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Added to Collection on: 2022-03-09 04:28:39

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Pharmaceutical industry
Health sciences
Health
Clinical research
Medical research
Medical statistics
Clinical trials
Clinical data management
Verification and validation
Validation
Clinical endpoint
Investigational device exemption
CyberActa Inc.
John Giantsidis

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FDA seeks input on new medical device cybersecurity guidance | Modern Healthcare

Added to Collection on: 2022-04-07 18:44:24

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Health sciences
Pharmaceutical industry
Food and Drug Administration
Health
Life Sciences
Medical devices
Medical device
Malware
Cyberwarfare
Computer security
Investigational device exemption
Clinical trial

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Endologix reports positive results from percutaneous bypass trial - MassDevice

Added to Collection on: 2022-06-23 16:23:31

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Investigational device exemption
Pharmaceutical industry
IDE
Food and Drug Administration
Health care
Medicine
Health sciences
Endologix

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A Step Forward: FDA Issues Three Draft Guidance Documents As Part of Efforts to ...

Added to Collection on: 2023-09-19 18:04:34

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Food and Drug Administration
Medical device
Federal Food, Drug, and Cosmetic Act
FDA Center for Devices and Radiological Health
Investigational device exemption
Title 21 CFR Part 11

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Microbot Medical is a step closer to an FDA IDE submission - MassDevice

Added to Collection on: 2023-12-07 16:33:55

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Pharmaceutical industry
Investigational device exemption
Clinical trial
Interventional radiology
Good laboratory practice
Microbot Medical

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Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints - Yahoo Finance

Added to Collection on: 2024-03-20 06:10:31

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Sleep disorders
Obstructive sleep apnea
Sleep apnea
Apnea–hypopnea index
Hypopnea
Ahi
Transoral robotic surgery
Polysomnography
Forward-looking statement
Apnea
Food and Drug Administration
Investigational device exemption
Nyxoah SA
United States
OSA company
Brussels

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Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints | Placera

Added to Collection on: 2024-03-19 20:09:01

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Sleep disorders
Obstructive sleep apnea
Sleep apnea
Forward-looking statement
Apnea–hypopnea index
Transoral robotic surgery
Polysomnography
Hypopnea
Ahi
Food and Drug Administration
Investigational device exemption
Nyxoah SA
United States
Apnea
Brussels

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FDA Promotes Clinical Trial Innovation

Added to Collection on: 2024-05-20 18:30:30

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Clinical research
Food and Drug Administration
Design of experiments
Drug discovery
Clinical trials
Investigational device exemption
Phases of clinical research
Drug development
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Investigator's brochure
Breakthrough therapy

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A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Added to Collection on: 2024-10-01 19:19:16

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Regulation of medical devices
Food and Drug Administration
Clinical research
Pharmaceuticals policy
Clinical trials
Postmarketing surveillance
Medical device
Medicines and Healthcare products Regulatory Agency
Biosimilar
Regulation (EU) 2017/745
Investigational device exemption
FDA Center for Devices and Radiological Health

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Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

Added to Collection on: 2024-11-06 08:28:02

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Food and Drug Administration
Pharmaceuticals policy
Food law
Federal Food, Drug, and Cosmetic Act
Medical device
FDA Center for Devices and Radiological Health
Investigational device exemption

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