UCM147126

UCM147126 - Contains Nonbinding Recommendations Guidance...

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Contains Nonbinding Recommendations Guidance for Industry and FDA Staff Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product Additional copies of this guidance are available at: http://www.fda.gov/oc/combination/default.htm or from: Office of Combination Products, HFG-3 15800 Crabbs Branch Way, Suite 200 Rockville, Maryland 20855 Phone: 301-427-1934 Fax: 301-427-1935 e-mail: [email protected] For questions regarding this document, contact Suzanne O’Shea at 301-827-1934 or by email at: [email protected] U.S. Department of Health and Human Services Food and Drug Administration Office of Combination Products
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Contains Nonbinding Recommendations TABLE OF CONTENTS I. Introduction . ................................................................................................................................ 1 II. What is a premarket review timeliness dispute?. ....................................................................... 2 III. What are the applicable time frames?. ...................................................................................... 3 IV. When should a timeliness dispute resolution request be presented? . ....................................... 4 V. What is the process for presenting a timeliness dispute resolution request to OCP? . ............... 5 VI. What information should be included in a timeliness dispute resolution request ? . ................ 6 VII. How will OCP respond to a request for resolution of a timeliness dispute?. .......................... 7 i
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Contains Nonbinding Recommendations Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product topic. FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this It does not create or confer any rights for or on any person and does not operate to bind You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. Introduction The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was enacted on October 26, 2002. Among other things, this act created the Office of Combination Products (OCP) within the Office of the Commissioner of Food and Drugs. One of OCP’s functions is to develop and implement policies and processes to streamline the review and regulation of drug- device, drug-biologic and device-biologic combination products as defined in 21 CFR 3.2(e). For example, OCP is responsible for overseeing the timeliness of, and coordinating reviews of combination products when more than one agency Center is involved. In addition, OCP is
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at UGA.

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UCM147126 - Contains Nonbinding Recommendations Guidance...

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