Tag Archive: 510(k)

Jan 11

FDA’s Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

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Jan 11

FDA's Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

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Nov 06

New Guidances from FDA for October 2012

FDA released four notable new guidances in October 2012, with a focus on guidances related to medical devices: Guidance: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R1) Guidance: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals Guidance: …

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Sep 07

De novo device reclassification: What have you done for me lately?

The recently passed FDA Safety and Innovation Act makes major changes to the de novo reclassification process for medical devices.  Namely, the new law mandates that a manufacturer can simply submit a request to the FDA for de novo classification without having a previously rejected 510(k) application. Medical devices are classified in a three-tiered classification …

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Jul 27

FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jul 20

FDASIA, Part 1: The “UFAs”

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part series, we will cover the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical Device Regulatory …

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Feb 20

New FDA Guidances – December 2011/January 2012

Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be found in this previous blog post) The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications …

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Aug 11

Divisive Devices or UFC 510(k): FDA Meets IOM

In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices.  This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by industry complaints about the review process, arguments over the safety of cleared devices, and a …

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Feb 22

A Brief Update on FDA’s Re-evaluation of the 510(k) Process

Change is in the air.  No, I’m not referring to the recent thaw here in Minnesota, but rather to the looming changes in the regulations governing medical devices in the U.S. First, a brief primer on the medical device approval process in the U.S.  Currently, all novel medical devices must be approved through a “de …

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Aug 23

CDRH Proposes Changes to the 510(k) Pathway

All for one, one for all, that is our device. – Alexandre Dumas The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look in the mirror in 2009.  With this period of introspection now complete, it has just …

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