The FDA releases its final recommendations on legal exemptions for customized medical devices.
The FDA yesterday released its final recommendations for legal exemptions for customized medical devices that deviate from already-approved systems by being tailored to the special needs of up to 5 patients.
Examples of such devices might include implantable devices like artificial discs or surgical screws for very tall people or infants that are otherwise unavailable in the correct size.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1mZB5vt
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