Extending Your Quality System from Medical Devices to Manufacturing of Combination Products, Your Unique Challenges and How to Overcome them



This webinar is intended to demonstrate 510(k) contents and format including 510(k) processes in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) preparation, submission and clearance, potentially leading to saving millions.

In June, 2013, FDA has cleared 211 devices (510(k)s) under the 510(k) program. Among those, there were three abbreviated and 49 special 510(k)s. Among 49 specials, there is a 510(k), which was filed in the middle of the year 2011. For the special 510(k), it has taken almost two years. On the other hand, in June, 2010, 2011 and 2012, FDA cleared 243, 240 and 258 devices (510(k)s), respectively.

Although it is believed there are various factors contributing to those 510(k) clearances, it is imperative more than ever from our industry perspectives that the medical device manufacturers understand recent changes (hurdles and new requirements) and be able to prepare a 510(k) in a sufficiently adequate way to expedite the review process and successful clearance without delays.

In this webinar, speaker will discuss what and how to do with your 510(k) preparation and submission. In particular, the speaker will share what he has learned from his own experience and also based on his analysis of 510(k)s recently cleared including those in June, 2013.

Areas to be Covered:

Statute(s) and regulations
Regulatory requirements for 510(k)s
Device classification and predicates
When 510(k)s are required
Demonstrating substantial equivalence
Recent 510(k) changes and requirements including e-Copy and RTA policy
Product codes
Regulatory requirements for products
How to address and present performance data and/or clinical data in a succinct, comprehensive manner.
How to respond to FDA’s request of additional information.
How to resolve different opinions between the submitter and FDA reviewer(s)

Who will Benefit:

Senior management
Anyone interested in 510(k) matters

Meena Chettiar

Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O’ Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years before immigrating to the United States.

Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010. Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several Compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter.

Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.


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