News & Industry Updates

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances detailing when a new 510(k) is required for changes made to medical devices or their software. In August 2016, FDA released the two draft guidances, five years after the agency’s first attempt to replace its 1997 guidance on 510(k) changes. But the agency withdrew the 2011 draft guidance after Congress ordered it to rethink the policies discussed in that version, which industry complained would lead to a major increase in the number of changes that would require a new 510(k). According to FDA, the final versions of the guidances have been updated for clarity and to ensure they are interpreted consistently by agency staff and device manufacturers. While the guidances are largely in line with the 2016 draft versions, FDA has added some additional information to clarify the guidances’ scope. FDA says the

Medical device decontamination becomes necessary when medical devices become soiled and contaminated with microorganisms after being used. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes. The avoid infection, these devices must undergo a detailed, multi-step process to clean and then disinfect or sterilize them. CG Labs ensures the reprocessing of reusable medical devices in order to protect patient safety. Since 1998, C.G. Laboratories, Inc. has been a leader in the decontamination of medical devices. We offer medical device decontamination (including cadaver trays) or other products that have been contaminated and potentially exposed to pathogens. In our decontamination lab, used medical devices (including paperwork) are decontaminated so that everything returned to our customers is safe. The medical device can be rendered safe by the use of: Ethylene Oxide Decontamination Steam Decontamination Gamma Radiation Decontamination Liquids Decontamination Custom Decontamination In addition, we