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De Novo Guidance

De Novo Guidance

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Published by: FDA Lawyers Blog on Oct 12, 2011
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Draft Guidance for Industry andFood and Drug AdministrationStaff 
 De Novo
Classification Process(Evaluation of Automatic Class IIIDesignation)
 DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
 
Document issued on: October 3, 2011
 
You should submit comments and suggestions regarding this draft document within 90 daysof publication in the
Federal Register 
of the notice announcing the availability of the draftguidance. Submit written comments to the Division of Dockets Management (HFA-305),Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submitelectronic comments tohttp://www.regulations.gov.Identify all comments with the docketnumber listed in the notice of availability that publishes in the
Federal Register 
.For questions regarding this document, contact Melissa Burns, 301-796-5616,melissa.burns@fda.hhs.govor CBER’s Office of Communication, Outreach and Developmentat 1-800-835-4709 or 301-827-1800.
When final, this document will supersede “New Section 513(f)(2) -Evaluation of Automatic Class III Designation, Guidance for Industry andCDRH Staff” dated February 19, 1998.
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological HealthOffice of Device EvaluationOffice of In Vitro Diagnostic DeviceEvaluation and SafetyCenter for Biologics Evaluation and Research
 
 
Preface
Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request todsmica@fda.hhs.govto receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1760) to identify theguidance you are requesting.Or contact:Office of Communication, Outreach and Development, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448Internet:http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htmTel: 800-835-4709 or 301-827-1800E-mail: ocod@fda.hhs.gov
 
Contains Nonbinding Recommendations
 Draft - Not for Implementation
Draft Guidance for Industry andFood and Drug Administration Staff 
 
 De Novo
Classification Process (Evaluationof Automatic Class III Designation)
This draft guidance, when finalized, will represent the Food and Drug Administration's(FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 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.
1.
 
Introduction
The purpose of this document is to provide guidance on the process for the submission andreview of petitions under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (theFD&C Act), also known as the
de novo
classification process. This process provides a routeto market for medical devices that are low to moderate risk, but that have been classified inclass III because FDA has found them to be “not substantially equivalent” (NSE) to legallymarketed predicate devices.FDA's guidance documents, including this guidance, do not establish legally enforceableresponsibilities. Instead, guidances describe the Agency's current thinking on a topic andshould be viewed only as recommendations, unless specific regulatory or statutoryrequirements are cited. The use of the word
should 
in Agency guidances means thatsomething is suggested or recommended, but not required.Throughout this guidance document, the terms “we,” “us” and “our” refer to FDA staff fromthe Center for Devices and Radiological Health (CDRH) or the Center for BiologicsEvaluation and Research (CBER) involved in the review and decision-making aspects of the
de novo
classification process. “You” and “your” refers to the submitter of a
de novo
petitionand/or related materials.
2.
 
Background
A device may be classified in class III and require premarket approval via several differentregulatory vehicles. In accordance with section 513(a)(1)(C) of the FD&C Act, FDA may3

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