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Edward M. Basile Document Search Results (6) Sort by:  | FDA Issues Two Draft Guidance Documents Related to Investigational Device Exemptions
Edward M. Basile, Laurie A. Clarke, Beverly H. Lorell, M.D., Jessica Ringel, Elaine H. Tseng, Lynette A. Zentgraft; King & Spalding LLP;
Legal Alert/Article November 18, 2011, previously published on November 17, 2011 On November 10, 2011, the Food and Drug Administration (FDA or the Agency) issued two draft guidance documents: Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Studies, Including Certain First in Human (FIH) Studies, and FDA Decisions for Investigational Device...
| | FDA Issues Draft Guidance on De Novo Classification Process
Edward M. Basile, Joanne H. Chan, Laurie A. Clarke, Elaine H. Tseng, Lynette A. Zentgraft; King & Spalding LLP;
Legal Alert/Article October 10, 2011, previously published on October 5, 2011 On October 3, 2011, FDA issued a draft guidance entitled, “De Novo Classification Process (Evaluation of Automatic Class III Designation).” In the guidance, FDA described the submission and review of petitions under the de novo classification process in section 513(f)(2) of the Federal...
| | FDA Issues Draft Guidance Regarding the Design of Pivotal Clinical Investigations of Medical Devices
Edward M. Basile, Laurie A. Clarke, Beverly H. Lorell, Elaine H. Tseng, Lynette A. Zentgraft; King & Spalding LLP;
Legal Alert/Article August 23, 2011, previously published on August 19, 2011 The Food and Drug Administration (FDA) issued a draft guidance on August 15 that sets forth the agency’s recommendations regarding the design of pivotal clinical investigations of medical devices. These recommendations are intended to help manufacturers and researchers design clinical...
| | FDA Issues Updated Draft Guidance on Device Modifications
Edward M. Basile, Mark S. Brown, Laurie A. Clarke, Marian Lee, Seth H. Lundy, Patrick Morrisey, Elaine H. Tseng, Lynette Zentgraft; King & Spalding LLP;
Legal Alert/Article August 12, 2011, previously published on August 9, 2011 On July 27, 2011, the U.S. Food and Drug Administration (FDA or “the Agency”) issued the much anticipated draft guidance addressing when modifications to cleared devices require new 510(k) premarket notifications. This new draft guidance, “510(k) Device Modifications: Deciding...
| | FDA Issues Draft Guidance on Mobile Medical Apps: Does the App Present a Risk to Patients if it Does Not Function as Intended?
Edward M. Basile, Laurie A. Clarke, Marian Lee, Beverly Lorell, MD, Jessica Ringel; King & Spalding LLP;
Legal Alert/Article July 27, 2011, previously published on July 25, 2011 On July 19, 2011, the U.S. Food and Drug Administration (FDA or the Agency) released a “Draft Guidance for Industry and Food and Drug Administration Staff” on “Mobile Medical Applications.” The draft announces FDA’s intention to regulate mobile applications (apps) that...
| | FDA Issues Draft Guidance for Clinical Investigators, Industry and FDA Staff: Financial Disclosure by Clinical Investigators
Edward M. Basile, Michelle Molloy Davalos, Beverly H. Lorell, M.D., Christina M. Markus, Kelly Nicole Reeves; King & Spalding LLP;
Legal Alert/Article June 2, 2011, previously published on June 1, 2011 The Food and Drug Administration (FDA) issued draft guidance on May 24 describing its current thinking on the disclosure of financial interests of clinical investigators updating the prior decade-old guidance issued on the subject. The new draft guidance is notable in that it provides more...
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