_______________________________
5條rules
#1唔準gel頭（城城任何一個部位都唔得
）#2要貼就只可以貼袋林
#3開市日要飲可樂
#4盤前唔好入
#5 Apple Watch問題一律建議買put
Gogogo不適用 呢隻係”全攻型“長持股，唔係連登仔嘅3日長持
check Reddit sens 熱度:https://www.topstonks.com/stocks/SENS
$SENS post 34 - Sens or Scam?
哥瑪先生monge
1001 回覆
6 Like
0 Dislike
_______________________________
5條rules
#1唔準gel頭（城城任何一個部位都唔得
）#2要貼就只可以貼袋林
#3開市日要飲可樂
#4盤前唔好入
#5 Apple Watch問題一律建議買put
Gogogo不適用 呢隻係”全攻型“長持股，唔係連登仔嘅3日長持
check Reddit sens 熱度:https://www.topstonks.com/stocks/SENS
Lm
開始每次睇到sens都會睇成scam
34係好number
究竟仲要留名幾多個post先會過fda
Lm
LM
其實有冇公佈過大約咩進度？
現價入唔入得過
現價入唔入得過
跌夠未呀 dllm
今日新低
癲
原來開左新PO
陰跌咗一排
現價all in
已穿
2.97
無底深淵
就黎跌到痴撚左線
https://www.qualio.com/blog/fda-medical-device-approval-process
Class 3 Devices
Class 3 medical devices are the most innovative and invasive devices, which potentially present the highest risks to patient health and safety. This class constitutes approximately 10% of devices and includes devices like cochlear implants, defibrillators, and implanted prostheses.
The majority of Class 3 devices follow the PMA pathway. PMA is the agency’s process of scientific and regulatory review and the most stringent type of application possible. The PMA pathway involves presenting adequate scientific evidence to demonstrate safety and efficacy.
While preparing a PMA application is generally significantly more intensive than a 510(k) app or self-registration, it’s surprisingly not much longer of a wait post-submission. According to a report from the agency, the average PMA application is approved 243 days post-submission. That’s just over eight months, or 66 days longer than the average time to approval for a 510(k) application.
Class 3 medical devices are being approved faster than ever before. The agency has worked in recent years to improve the PMA pathway and reduce the wait time while maintaining a focus on patient safety. Prior to 2010, the average wait for a PMA approval was 345 days or nearly 12 months. That’s a speed-to-market increase of 111 days, on average, in the past nine years. Currently, 92% of PMA applications are approved by the agency.
Class 3 Devices
Class 3 medical devices are the most innovative and invasive devices, which potentially present the highest risks to patient health and safety. This class constitutes approximately 10% of devices and includes devices like cochlear implants, defibrillators, and implanted prostheses.
The majority of Class 3 devices follow the PMA pathway. PMA is the agency’s process of scientific and regulatory review and the most stringent type of application possible. The PMA pathway involves presenting adequate scientific evidence to demonstrate safety and efficacy.
While preparing a PMA application is generally significantly more intensive than a 510(k) app or self-registration, it’s surprisingly not much longer of a wait post-submission. According to a report from the agency, the average PMA application is approved 243 days post-submission. That’s just over eight months, or 66 days longer than the average time to approval for a 510(k) application.
Class 3 medical devices are being approved faster than ever before. The agency has worked in recent years to improve the PMA pathway and reduce the wait time while maintaining a focus on patient safety. Prior to 2010, the average wait for a PMA approval was 345 days or nearly 12 months. That’s a speed-to-market increase of 111 days, on average, in the past nine years. Currently, 92% of PMA applications are approved by the agency.
又做乜撚啊 兩個星期跌25%
兩個星期跌25%