The American Orthotic & Prosthetic Association (AOPA) recently announced its intent to attend the upcoming 2012 FDA Compliance Workshop in Baltimore, Md, slated for February 24. AOPA urges other organizations to join the one-on-one seminar, which will examine the compliance policies that are required of the orthotic and prosthetic (O&P) industry by the US Food and Drug Administration (FDA), reports an AOPA press release. The seminar will take place at the Sheraton Inner Harbor Hotel.
The release adds that the FDA regulatory compliance awareness is essential in order to provide O&P manufacturers, suppliers, component manufacturers, and distributors with an understanding of FDA regulations that apply to the O&P industry.
The compliance training is designed to reinforce O&P organizations’ understanding of applicable FDA regulations as they relate to manufacturing and distribution practices, medical devices and device classification, forms, fees, and key contacts. The training is also meant to educate organizations in order to protect against severe penalties that they may suffer if they are in not in compliance, the AOPA release says.
A key point of interest that may be noted in the compliance workshop, AOPA adds, is whether FDA good manufacturing practices (GMP) applies to O&P Patient Care Facilities, particularly those with central fabrication companies.
For more information, click here.