Author Archive for Food and Drug Adminstration (FDA): CDRHNew
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 4th, 2008 in Regulatory AffairsThe FDA is is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register…
Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff
Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 2nd, 2008 in Regulatory AffairsTopics: Medical Device User Fee and Modernizaton Act of 2002 (MDUFMA), Premarket Approval
Nature and Basis Statements of Conflicts(s) of Interest for December 15, 2006 Meeting
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 29th, 2006 in Regulatory AffairsTopics: Advisory Committee and Panel Meetings
Japan - U.S. “Harmonization By Doing” HBD Pilot Program Initiative
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 27th, 2006 in Regulatory Affairs?Harmonization by Doing,? commonly known as HBD, is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals. This process is a cooperative effort to move both Japan and..
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Fiscal Year 2005 Annual Report
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 27th, 2006 in Regulatory AffairsTopics: Annual Reports, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability; Extension of Comment Period
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 27th, 2006 in Regulatory AffairsThe FDA is extending the comment period on the draft guidance entitled “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.’
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability; Extension of Comment Period.
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 27th, 2006 in Regulatory AffairsThe FDA is extending the comment period on the draft guidance entitled “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.’
Federal Register: Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Availability; Extension of Comment Period.
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 27th, 2006 in Regulatory AffairsThe FDA is extending the comment period on the “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.’
Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers - Decorative, Non-corrective Contact Lenses
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 23rd, 2006 in Regulatory AffairsOn November 9, 2005, section 520(n) was added to the Federal Food, Drug, and Cosmetic Act (the Act) by Public Law 109-96 to establish that all contact lenses are devices under section 201(h) of the Act. Because all contact lenses are now regulated as…
Federal Register: Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers; Decorative, Non-Corrective Contact Lenses; Availability.
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 23rd, 2006 in Regulatory AffairsThis guidance document explains recently enacted legislation under which all contact lenses are deemed devices within the meaning of the Federal Food, Drug, and Cosmetic Act (the act). All contact lenses, including decorative, non-corrective contact…
Medical Devices Dispute Resolution Panel, December 15, 2006 - Notice of Meeting
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 23rd, 2006 in Regulatory AffairsThe committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Acorn Corp. related to the approvability of a premarket approval application for the CorCap Cardiac Support Device for patients with…
Medical Device Safety, Tips & Articles: Cables and Electrodes Can Burn Patients During MRI
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 21st, 2006 in Regulatory AffairsArticle reprinted from Nursing2006, Volume 36, Number 11, p. 18. PATIENTS UNDERGOING magnetic resonance imaging (MRI) while wearing ECG electrodes attached to cables have received second- and third-degree burns on skin under the electrodes. These burns…
Circulatory System Devices Panel Meeting, December 7-8, 2006 - Nature and Basis Statements of Conflict(s) of Interest
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 21st, 2006 in Regulatory AffairsTopics: Advisory Committee and Panel Meetings
Clinical Chemistry and Clinical Toxicology Devices Panel Meeting, December 6, 2006 - Notice of Meeting
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 21st, 2006 in Regulatory AffairsTopics: Advisory Committee and Panel Meetings
Federal Register: Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing.
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 20th, 2006 in Regulatory AffairsThe FDA is announcing a public hearing to solicit general views and information from interested persons on issues concerning the electronic submission of product information to the agency.
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Archive for Food and Drug Adminstration (FDA): CDRHNew.
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