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What's New with the FDA?

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Feb 09 in Regulatory Compliance 0 Comments

solutions_buttonOCRA member Jack Dhuwalia summarizes FDA Los Angles Acting District Director Capt. Larry Howell’s summary of major Washington-based FDA overhaul coming soon.

One significant announcement was the resignation of Dr. Margaret A. Hamburg as the FDA’s commissioner.

To learn more about significant changes at the FDA coming in 2015 ... continue reading below


OCRA (Orange County Regulatory Affairs Discussion Group) member Jack Dhuwalia comments on the “Day at the District” news disclosed at the Annual Orange County OCRA and FDA Los Angeles District joint discussion group. A nonprofit, volunteer organization composed of Regulatory Affairs professionals from the Southern California area - OCRA members expand their knowledge through educational programs and networking. The 700+ members represent more than 225 OC companies in the Life Sciences industries, including: medical devices, pharmaceutical, biologics, IVD, dietary supplement, food, and cosmetics, to mention a few. 

Key FDAChanges Expected:

  1. Specialization – Keeping up with the challenges
  2. Major Reorganization - (at all levels): To become more efficient for timely results
  3. Risk Based Approach - (hasn’t changed): Focus on risky products, risky companies, to balance risk with benefit for new treatments
  4. Leverage - To do more with less
  5. Inspection Team - Please see below **
  6. 2015 FDA will operate totally differently - Might take a while (6 months) to get going but it’ll be focused
  7. Lab Optimization & Specialization - Streamline, highly specialized  

** Inspections Detail:

Who? - It is likely that FDA inspections will be tougher by targeting risky companies (recurring non-compliance) with inspection teams consisting of specialists, which in the past were called after-the-fact by the investigators. The new approach will include them with the original investigation team to make it timely and impactful.

When? - It might take six months to implement these and other changes. To me, this serves as a notice to non-compliant companies as well those that have significant recalls/product problems.

Why? - "Public Health" and working more efficiently continues to drive these changes.

Where? Within US then OUS since more than half of devices are now imported and more than 80 percent of API are imported. Many quality concerns exist about raw materials coming from India and China.

How? The US inspections will be performed by teams – local districts such as LA Dist. will remain the focal point. The OUS inspections will be substantially improved – to be determined (TBD). It is more likely that FDA will honor inspections from EU and other countries – TBD. Sending investigators from US simply is inefficient and leveraging might work better.

The views expressed are those expressed by Mr. Dhuwalia; they do not necessarily represent FDA or OCRA.

Jack Dhuwalia is an active leader in the Southern California medical products community. He is an active senior member of industry organizations, a degreed engineer, MBA, ASQ certified Six Sigma Black Belt, and ASQ Certified Quality Manager. Dhuwalia presents programs on FDA/ISO requirements, supplier quality, design controls, root cause analysis, CAPA risk management and lean manufacturing. You can contact Dhuwalia at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it. or   949-701-0214.


About the author

Jack Dhuwalia

Jack is an expert trouble-shooter specializing in the medical industry. He has been problem-solving in R&D, manufacturing, regulatory and quality areas. Since 1992, he co-founded JD Consulting, a firm specializing in the medical industry including: devices, in vitro diagnostic devices, biologics and drugs.

Jack has expertise in design control, risk management, root cause analysis and CAPA. He teaches a graduate-level medical products life-cycle class at UCI. He is a guest lecturer at USC on quality and regulatory issues. He is a published author and has spoken on Root Cause Analysis and CAPA during FDA-OCRA events. He enjoys sharing his knowledge and public speaking.

He has served as the Membership Chair for the Orange Empire Section of ASQ and was on the executive board of OCRA, a professional organization for quality / regulatory affairs.

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