No video

Breakthrough Device Designation Guidance Updated for 2023

  Рет қаралды 365

Medical Device Academy

Medical Device Academy

Күн бұрын

What has changed in the guidance?

Пікірлер: 2
@tifanychesser6286
@tifanychesser6286 8 ай бұрын
How often does the FDA update the guidances?
@MedicalDeviceAcademy
@MedicalDeviceAcademy 8 ай бұрын
The FDA now has a policy to review all guidance documents every 10 years to identify if there are guidance documents that need to be updated. Since there are guidance documents dating all the way back to the 1980s, they are currently playing catch-up. They are doing retrospective reviews of the following years in 2024: 1994, 2004, and 2014. They also publish a list of guidance documents that are planned for revision each year. The list is divided into 4 parts: 1) A-list final guidance, 2) B-list final guidance, 3) A-list draft guidance, and 4) B-list draft guidance. Sometimes the FDA decides not to update a guidance, because there is no urgent need. Other documents get updated as frequently as once per year. Pilot programs that are new fall into the category of needing updates frequently, such as the breakthrough program.
How do clinical trials work for a medical device in the USA?
27:26
Medical Device Academy
Рет қаралды 1,7 М.
What is Breakthrough Device Designation?
8:34
Medical Device Academy
Рет қаралды 393
КАКУЮ ДВЕРЬ ВЫБРАТЬ? 😂 #Shorts
00:45
НУБАСТЕР
Рет қаралды 3,5 МЛН
Underwater Challenge 😱
00:37
Topper Guild
Рет қаралды 41 МЛН
Мы сделали гигантские сухарики!  #большаяеда
00:44
What will he say ? 😱 #smarthome #cleaning #homecleaning #gadgets
01:00
Auditing design and development - A live demo
29:56
Medical Device Academy
Рет қаралды 87
SYS-002 Control of Records Webinar
37:54
Medical Device Academy
Рет қаралды 56
Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation
58:38
Friends of Cancer Research
Рет қаралды 923
Medical Device and IVD Global Market Entry Strategies | LSI Europe '22
38:20
LSI - Life Science Intelligence™
Рет қаралды 857
How to Qualify for FDA's Breakthrough Devices Program 2023
13:15
MedTech Crossroads
Рет қаралды 179
FDA Approval Pathways 101
1:29:00
Alliance for Health Policy
Рет қаралды 6 М.
Understanding the Difference Between FDA Approval and FDA Clearance
4:25
MedTech Crossroads
Рет қаралды 8 М.
When is the right time to have a design freeze for a medical device?
15:55
Medical Device Academy
Рет қаралды 62
КАКУЮ ДВЕРЬ ВЫБРАТЬ? 😂 #Shorts
00:45
НУБАСТЕР
Рет қаралды 3,5 МЛН