Medical Devices: Technological Innovation and Patient/Provider Perspectives, Hearing Before the Committee on Commerce, U.S. House of Representatives

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Michael Bilirakis
DIANE Publishing, Jun 1, 1997 - 86 pages
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Hearing on technological advances in the field of medical devices from the perspective of the Food & Drug Admin. (FDA), as well as from patients & providers. Witnesses: Michael Friedman, Bruce Burlington, & Susan Alpert, FDA; John F. Hansbrough, Dir. of the Regional Burn Center, UCSD Medical Center; C. Warren Olanow, Chairman, Dept. of Neurology, Mount Sinai Medical Center; Robert A. Schmidt, Dir. of Mammography, Univ. of Chicago Hospitals; Joseph M. Smith, Asst. Prof. of Medicine, Washington University School of Medicine; & Joy Vaas. Also includes prepared statement submitted by Nonprescription Drug Manufacturers Assoc .
 

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Page 10 - ... to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. (i) The term "cosmetic...
Page 10 - Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals...
Page 7 - I look forward to working with my colleagues on both sides of the aisle to reauthorize PDUFA and work for even more improvements in FDA's review processes for new drugs and biological products.
Page 14 - FDA's commitment to industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. We recognize that this can only be attained through a collaborative effort — between FDA and industry — grounded in mutual respect and responsibility. The protections afforded the American consumer, and the benefits provided the medical device industry, cannot be underestimated.
Page 4 - I thank the gentleman and without objection, of course, the opening statement of all members of the subcommittee will be made a part of the record. [The statements follow:] PREPARED STATEMENT OF HON.
Page 84 - ... state standards would render it difficult, if not impossible, to distribute OTC drugs on a nationwide basis. In 1991, a blue ribbon panel of FDA experts, chaired by former FDA Commissioner Charles C. Edwards, MD, unanimously included national uniformity for OTC drugs among their recommendations for FDA reform. The panel's recommendation followed the action of Congress to require national uniformity in the Nutrition Labeling and Education Act of 1990 and other modern statutes regulating nationally...
Page 83 - Three statements dealt with sources of information about OTCs. Eighty-seven percent said that reading package labels is one way they decide which OTC to take; 81% said a pharmacist is a good source of information; and 73% said advertising helps them learn what medicines are available for what problems. Findings such as these support the role of nonprescription medicines as an important and responsibly used tool for safe and effective self-care. B. FDA Regulation of Nonprescription Medicines FDA has...
Page 12 - State" includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa. ELECTRONIC PRODUCT RADIATION CONTROL PROGRAM SEC. 356. (a) The Secretary shall establish and carry out an electronic product radiation control program designed to protect the public health and safety from electronic product radiation. As a part of such program, he shall — (1) pursuant to section...
Page 12 - MQSA required the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accreditation bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance.
Page 83 - ... of the drug, along with labeling and other information. While historically FDA used the OTC Drug Review (and an earlier “switch regulation” process) to switch drugs from prescription to OTC status, in the past decade the agency and industry have relied increasingly on the NDA process for these switches (including the introduction of lower-dose OTC versions of prescription medicines). Recent switches accomplished through NDAs include the pain relievers ibuprofen, naproxen, and ketoprofen;...

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