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Question:  What are the classifications in Medical devices as per FDA?

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DOUBLE-DUMMY
A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active).
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The Supreme Court has asked the Union Government to submit details of the number of deaths and severe adverse effects (SAEs) caused to people during the clinical trials.

A bench headed by Justice R M Lodha issued the order on Monday while hearing a petition by ...

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FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids

In a safety communication notice issued by the U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of ...

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The EU guidelines below have been recommended for adoption or non-adoption by the TGA. These guidelines are open for comment on whether or not they should be adopted in Australia.

Submission of comments

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FDA warns consumers not to use Zi Xiu Tang Bee Pollen capsules

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AUDIENCE: Consumer, Dentistry, Emergency Medicine, Internal Medicine, Pharmacy, Pain Management, Surgery

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Opinion Poll

Which ISO Standards covers clinical investigation of medical devices for human subjects?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

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