Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

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The FDA has issued a final guidance document for industry on “Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.” The FDA also is soliciting comments on a number of draft guidance documents, including the following:

• Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications; to be considered by the agency in developing the final guidance, comments should be submitted by December 30, 2009.
• The Scope of the Prohibition Against Marketing a Tobacco Product in Combination With Another Article or Product Regulated Under the Federal Food, Drug, and Cosmetic Act;  comments are due January 4, 2010.
• Mammography Quality Standards Act Final Regulations; comments will be accepted until January 7, 2010.