Tag Archives: FDA

22Aug/18
FDA-Pre-Check

Do You Want Less FDA Inspections? Here is FDA’s RX

Quality Metrics Program Update: We Asked and FDA Answered

By: Sandra K. Rodriguez, Market Analyst

The Quality Metrics program is a key step in the Agency’s objective to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.  

FDA recently published two announcements on the Quality Metrics program in the Federal Register: 

  • CDER intends to further develop a Quality Metrics Program through formal meeting requests and a pilot study to gain feedback from those establishments for which meeting requests do not apply 
  • CDER and CBER are initiating a 2018 Quality Metrics Site Visit Program to assist the Agency in understanding existing programsii 

These announcements prompted a number of industry executive to reach out to Axendia to understand FDA’s current thinking on Quality Metrics. 

For a first-hand account, we reached out to FDA with a few questions – we asked and they answered. [1]

AXENDIA: What drove the delays in the program?

FDA: There were many comments submitted to the docket after the revised draft 2016 guidance was published.  The comments generally indicated that additional feedback and a pilot would be useful.  Further, we took time to listen to additional comments and feedback from industry and industry trade organizations provided at conferences and presentations.  We determined that our next steps should be a Feedback Program and Site Visit Program which would allow individual companies an opportunity to discuss their approaches from different sub-sectors of the industry.  Continue reading

02Aug/18
Outcome based Medicine-Low-Res

FDA: Simulation is Digital Evidence, Not Made Up Stuff

Digital Evidence is Already Being Used at FDA to Support Regulatory Submissions

By: Daniel R. Matlis, President

Tina Morrison PicFDA is leading the way in the use of simulation and modeling in the medical device industry. “Simulation is digital evidence, not made up stuff,” said Tina Morrison Ph.D., Deputy Director, Division of Applied Mechanics, OSEL, CDRH, U.S. FDA, during her keynote address on Day 2 of the Siemens PLM Industry event, hosted by Medtronic at their operational HQ in Minneapolis, MN.

For details on Day 1 of the event see At 21, Computer System Validation Comes of Age.

Day 2 also included presentations from Medtronic, Atrium Health, Siemens Healthineers, and Agilent Technologies on their use of simulation and modeling across the product lifecycle and the environment of care.

“Access to safe and effective medical device technology calls for Regulatory Grade computer models & simulations,” said Morrison.

“Many companies aim for the Digital Twin and end up getting a Digital Mutant” commented Brent Roberts, Vice President of Medical Supply Chain Strategy at WL Gore.  “I think one of the keys to ensuring you don’t end up with a digital mutant is to stick with partners who understand the journey and rely on them helping you translate your internal view to a rest of the world outlook,” Roberts added.

To receive a copy of this brief, please register here.

We also welcome you to Register for FDA Grand Rounds “Advancing Regulatory Science with Modeling and Simulation at FDA” on August 9, 2018 from 12 – 1pm EST.

19Jul/18
Validation - original (1)

At 21, Computer System Validation Comes of Age

Stop Validating Computer Systems to Death!

By: Daniel R. Matlis, President

“FDA emphasizes that manufacturers are responsible for the adequacy of the software used in their devices and activities used to produce devices.  When manufacturers purchase “off-the- shelf” software, they must ensure that it will perform as intended in its chosen application.

FDA has amended the requirement to state, “When computers or automated data processing systems are used as part of production or the quality system,” for clarification. Software used in production or the quality system, whether it be in the designing, manufacturing, distributing, or tracing, must be validated.”[1]

According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the MedTech industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risk to patients.  This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices.  Additionally this single-mindedness has led to low rates of investment in automation and digital technologies. Continue reading

13Jul/18
Lucky 13-700x400

Lucky 13! What’s in a Number?

At Axendia, We Consider 13 More Than a Lucky Number!

We are quickly approaching our 13 Year Anniversary!  Since 2005, we have been providing trusted advice to Life-Science Industry Executives on Business, Regulatory and Technology Matters. It’s more than just luck, our analysts help a diverse set of clients achieve positive disruption through primary research and deep industry experience in a complex and highly regulated Industry.  Not only is our staff passionate about what they do, they average 20 years of Life-Science industry experience.

As a result, Axendia has proudly built long-term relationships across a broad industry ecosystem including:

Life-Science and Healthcare Organizations 68530 Connected Doctor

We provide strategic advice on key initiatives and understand the issues and priorities facing Industry Executives. We architect strategic road-maps to support positive disruption.

Examples include:

Continue reading

29May/18
483-6Sigma

FDA: Consumers and Patients Deserve Six Sigma Quality Products

Compliance vs. Quality – Interphex Edition

By: Daniel R. Matlis, President

Last month, I had the privilege to heaYU-Interphex-2018r Lawrence Yu, PhD, FDA Deputy Director of CDER’s Office of Pharmaceutical Quality (OPQ) at INTERPHEX 2018.

The theme of his presentation “The Future of Pharmaceutical Quality and the Path to Get There,” was that consumers and patients deserve six sigma quality products.

To encourage this effort, the Agency began the drive to modernize its regulation of the pharmaceutical industry to emphasize Quality more than a decade ago with the 21st Century Initiative.

Continue reading