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Archive for the ‘sterilization’ Category

Packagers: Get to Know Your 510(k)s

Tuesday, July 26th, 2011

FDA has issued draft guidance to help medical device manufacturers understand when a change to a previously cleared 510(k) device may require a new premarket notification submission. According to the agency, most packaging changes do not require a new 510(k). But there are some areas you should study closely. In the ...