Remember ...the joke was that the rabbit
died....?
Now, women are no longer bound to the advice of a doctor- they can accurately discover if they are pregnant.
Now, women are no longer bound to the advice of a doctor- they can accurately discover if they are pregnant.
Compliance Consultants has submitted both quantitative,
semi-quantitative in vitro diagnostic assay and qualitative
test strips.
The FDA has a policy - do not allow a medical device to change the practice of medicine. This is illustrated by the old practice that a woman had to go to a doctor to be told she was pregnant, and was forbidden by medical convention to conduct this analysis at home in her own privacy. Physicians argued a women needed the physician's advice.
This pregnancy test was not by a limitation of science and was not a safety issue -but by a limitation of medical convention. It was political. Nothing has changed.
The FDA has a policy do not allow a medical device to change the practice of medicine this is illustrated by the old practice that a woman had to go to a doctor to be told she was pregnant and was incapable of conducting this analysis at home in her own privacy said she could not interpret the results correctly.
Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices http://www.fda.gov/MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/ucm262292.htm
In Vitro tests, Regulation Number: 864.542520, Product Code:JPA
The FDA has a policy - do not allow a medical device to change the practice of medicine. This is illustrated by the old practice that a woman had to go to a doctor to be told she was pregnant, and was forbidden by medical convention to conduct this analysis at home in her own privacy. Physicians argued a women needed the physician's advice.
This pregnancy test was not by a limitation of science and was not a safety issue -but by a limitation of medical convention. It was political. Nothing has changed.
The FDA has a policy do not allow a medical device to change the practice of medicine this is illustrated by the old practice that a woman had to go to a doctor to be told she was pregnant and was incapable of conducting this analysis at home in her own privacy said she could not interpret the results correctly.
Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices http://www.fda.gov/MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/ucm262292.htm
In Vitro tests, Regulation Number: 864.542520, Product Code:JPA
