Monday, March 19, 2012
More Fundraising Changes Afoot?
I have chronicled in the past months several potential important changes to the laws and rules affecting small businesses raising investment capital. It seems as if there is a new proposal put forth every few months lately. One of the latest: In early March, the U.S. House of Representatives passed a bill to raise the upper limit on how much a company can raise without registration from the current $5 million to a new figure of $50 million. The bill must pass muster in the Senate and then be signed by the President to become law, of course. The SEC is doing its best to maintain its stranglehold over your activities, however, with Chairwoman Shapiro sending a letter to senators coming out strongly against the change.
Monday, March 05, 2012
FDA 101
If you are contemplating development of a physical or software product that is in any way used in medicine, you need to immediately determine whether the FDA considers your product to be a medical device. Many entrepreneurs naively wait too long to get this determination. You need to be aware that if yours is considered to be a medical device, even your product development process is subject to regulation, through the FDA's design controls.
The easiest and best way to determine if yours is considered a medical device is to call the FDA's Division of Small Manufacturers, International and Consumer Assistance at 800-638-2041 or 301-796-7100.
Be aware that the use of off-the-shelf software in medical applications is also subject to FDA regulation. You can learn more about this at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#8
If yours is considered a medical device, the way forward varies from quite easy to extremely difficult, depending on many factors. Be sure to consult with someone who thoroughly knows the process. I do not recommend that you try to figure it out by using the FDA website or googling various topics, as it is far too complex for that.
Be aware that the FDA also regulates devices used in veterinary medicine. You can learn more about this at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/default.htm
Oh, and one more thing: Any establishment involved in the production and distribution of medical devices must be registered with the FDA. More information about this is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm
The easiest and best way to determine if yours is considered a medical device is to call the FDA's Division of Small Manufacturers, International and Consumer Assistance at 800-638-2041 or 301-796-7100.
Be aware that the use of off-the-shelf software in medical applications is also subject to FDA regulation. You can learn more about this at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#8
If yours is considered a medical device, the way forward varies from quite easy to extremely difficult, depending on many factors. Be sure to consult with someone who thoroughly knows the process. I do not recommend that you try to figure it out by using the FDA website or googling various topics, as it is far too complex for that.
Be aware that the FDA also regulates devices used in veterinary medicine. You can learn more about this at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/default.htm
Oh, and one more thing: Any establishment involved in the production and distribution of medical devices must be registered with the FDA. More information about this is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm
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