Life is a Journey..how to make the best of it!

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al

BayBiotech.NET STED is a harmonized submission format for regulatory submissions developed by the Global Harmonization Task Force (GHTF). GHTF is a voluntary partnership of government and industry representatives from the United States and four other member states: Australia, Canada, the European Union, and Japan. Main objective of the GHTF is to promote international harmonization of medical device regulation through the preparation and distribution of guidelines such as the proposed STED format. CDRH has implemented a voluntary pilot premarket review program intended to assess the feasibility of the STED format and content for certain PMA applications and 510(k) submissions and encourages medical device manufacturers to participate in the STED Pilot Program. The participation in the program will benefit the manufacturers especially those seeking international regulatory approval/clearance for their devices. To find out more about the program as well as the eligibility of you