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Posted 12 December 2013 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) is preparing to potentially expand a rarely used program intended to help the agency conduct inspections of medical device manufacturers.
The program, known as the Medical Device Inspection Program (MDIP), allows manufacturers of low-risk (Class I and II) medical devices to be inspected for compliance with good manufacturing practices (GMPs) by state-not federal-regulators.
Per Section 510(h) of the Federal Food, Drug and Cosmetic Act (FD&C Act), establishments that manufacture devices are subject to inspection, and higher-risk devices (Class II and III) are subject to inspections every two years. However, FDA can contract out its responsibility to states, which it does on occasion.
As of 2012, only one state, Texas, was under contract with FDA to conduct the inspections. Using $78,000 in funding, it conducted 20 inspections, according to FDA.
According to FDA's inspection manual, it has also contracted with California and Colorado in past years.
The theoretical benefit of the program is that it allows companies with low-risk products to obtain faster inspections, allowing their products to reach the market more quickly.
Now, in a little-noticed solicitation posted to FDA's Federal Business Opportunities (FBO) website, FDA says it's looking to potentially expand the program further.
FDA said that shortly after the start of the new year, it will award contracts to state agencies to inspect medical devices.
"The state agencies must have the authority and capability required to gain access to private commercial establishments in order to conduct regulatory inspections in accordance with the Federal Food, Drug and Cosmetic Act," FDA wrote. "It is anticipated that awards will be made for a 12-month base contract period and two option years."
The contract solicitation is expected to be posted on 8 January 2014, FDA said.
FDA Contract Notice
Tags: State, medical device
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