FDA Regulatory Consulting and Training Services

20
May

Movie for Chasing the Dragon – Opioid Addiction

Opioid Addiction Chasing the Dragon: The Life of an Opiate Addict The following movie is for awareness purposes regarding Opioid Addiction in the US.  In the US, it has been a growing epidemic of prescription drug and heroin abuse. The US FBI and DEA have released a movie entitled “Chasing the Dragon: The Life of an Opiate Addict“, a documentary

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11
May

AHRQ Hospital Survey Report on Patient Safety Culture

Agency for Healthcare Research and Quality (AHRQ) User Comparative Database Report Many hospitals revealed their interest in comparing their results on patient safety culture to other hospitals using the AHRQ hospital survey on Patient Safety Culture. The AHRQ issues 2016 Hospital Comparative Database Report in 87 pages (downloadable in PDF below). 2016 Hospital Comparative Database Report (“Report”) The latest edition of

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26
Apr

21 CFR 820.70 Production and Process Controls

21 CFR PART 820 QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls 820.70 Production and process controls (a) General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control

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22
Apr

FDA Ban on Electrical Stimulation Devices

Electrical Stimulation Devices (ESDs) ESDs Are Intended to Treat Self-injurious or Aggressive Behavior The United States Food and Drug Administration (FDA) published a final  rule to ban electrical stimulation devices ESDs because they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling. “Since ESDs were first marketed

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21
Apr

Improving Awareness of the Importance of Human Factors

Awareness Is Important FDA recently issued draft guidance entitled “List of Highest Priority Devices for Human Factors Review,” informing medical device manufacturers which device types should have human factors data included in premarket submissions (i.e., for PMA or 510(k)). According to the guidance, it seems that FDA believes these device types have clear potential for serious harm resulting from use error, and that

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19
Apr

FDA Reclassifies Cardiovascular EPPG and PSA Devices into Class II

FDA Final Order for Medical Device Reclassification Reclassification of Cardiovascular Devices External Pacemaker Pulse Generator and Pacing System Analyzers 21 CFR Part 870 FDA issues Final Order, effective as of April 18, 2016, to reclassify external pacemaker pulse generator (EPPG) as well as to create a separate classification regulation for pacing system analyzers (PSAs) devices and reclassify PSA devices into

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12
Apr

FDA Approved First Biosimilar Zarxio filgrastim-sndz

The First FDA-Approved Biosimilar Zarxio filgrastim-sndz March 6, 2015 The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based

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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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24
Mar

Don't Hesitate to Say I Am Sorry After Medical Errors

A woman patient, Deborah Craven (60) is now suing prominent surgeons and the Yale University Hospital in New Haven, CT after receiving a wrong operation, removing the wrong body part (rib).  The patient ended up getting two surgeries in one day. Her lawyer states she is suing because she never heard the two words “I am sorry.” Read more from CNN

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23
Mar

US Congressman Sent a Letter to Veterans Affairs Not to Allow Essure

Hon. Mike Fitzpatrick Sent a Letter to the Veterans Affairs and Related Agencies Not to Purchase Medical Device Essure March 1, 2016 The Honorable Charlie Dent Chairman Subcommittee on Military Construction, Veterans Affairs and Related Agencies HVC-227 The Capitol Washington, DC 20515 The Honorable Sanford Bishop, Jr. Ranking Member Subcommittee on Military Construction, Veterans Affairs and Related Agencies HVC- 227

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