Tag: FDA Guidance

6
Apr

FDA Approved an IND for Zika Virus

U.S. Food and Drug Administration An IND Approved for Zika Virus The US FDA recently approved an investigational new drug application (IND)* for a test to screen blood donations for Zika virus.  The test is manufactured by Roche Molecular Systems, Inc. (Roche). *: The IND regulations 21 CFR Part 312 (downloadable in PDF here) provides procedures and requirements governing the use of

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16
Nov

FDA Guidance When Transferring Clinical Investigation Oversight

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board May 23, 2014 The Food and Drug Administration (FDA) issued a guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.” The guidance discusses regulatory responsibilities of institutional review boards (IRBs), clinical

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25
Jul

FDA Traditional 510k Guidance

FDA Guidance for Industry and Food and Drug Administration Staff The 510(k) Program Evaluating Substantial Equivalence in Premarket Notifications Issued: July 28, 2014 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled  “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” This guidance document describes FDA’s current review practices for premarket notification (510(k)) submissions by

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8
May

FDA Is Withdrawing the Following 47 Guidance Documents

FDA Withdrawal of Draft Guidance Documents Published Before December 31, 2013 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1419] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the withdrawal of 47 draft guidance documents that published before December 31, 2013, and have never been finalized. FDA is

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29
Jul

FDA Issued Final Guidance for The Traditional 510k Program

FDA Guidance for Industry  The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications Issued: July 28, 2014 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled  “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” This guidance document describes FDA’s current review practices for premarket notification (510(k)) submissions by describing in greater detail the

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15
Jul

FDA Draft Guidance Issued for Informed Consent Information Sheet Guidance for IRBs, CIs and Sponsors

FDA Draft Information Sheet Guidance on Informed Consent By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 24, 2014 July 2014 This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. This guidance is intended to provide information to

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14
Jul

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in 510ks

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics Draft Guidance for Industry and Food and Drug Administration Staff By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 24, 2014 July 15, 2014 Today, FDA issues an important guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket

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1
Jul

Types of Communication During the Review of Medical Device Submissions

Types of Communication During the Review of Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) Document issued on: April 4, 2014 During the review of a premarket submission, FDA’s practice has been to communicate with applicants through either a formal communication (such as a Major Deficiency Letter or

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24
Jun

Medical Device Adverse Event Reporting in EU, Health Canada and FDA

By Regulatory Doctor; LinkedIn; Google Plus; Twitter Here is a list of applicable guidances from EU Commission, Health Canada and US FDA.  The following will be helpful when you establish and maintain your adequate procedures for reporting medical device adverse events in EU, Canada and US. European Union (EU) EU MEDDEV 2.12/1 Rev 8, January 2013 Health Canada 2011 October Health Canada Mandatory

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27
May

IRB CIs and Sponsors Considerations When Transferring Clinical Investigation Oversight

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board May 23, 2014 The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.” The guidance announced in this document discusses

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