510(k) for IVDs



This webinar is intended to demonstrate 510(k) contents and format including 510(k) processesin accordance with FDA’s eCopy and RTA policy, helping you streamline your 510(k) preparation, submission and successful clearance for IVDs, saving days, weeks or months of your time and efforts.

In August, 2013, FDA has cleared over thirty (30) 510(k)s) for IVDs under the 510(k) program. Among those, nine (9) 510(k)s have taken almost a year to get them cleared.

Although it is believed there may be various factors contributing to those nine (9) 510(k) clearances taking longer than 90 days, 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, leading successful clearances 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 the above-mentioned nine (9) IVD 510(k)s cleared in August, 2013.

This webinar will greatly help you get better familiar with 510(k) contents and format including 510(k) processesso that a firm can prepare and submit a 510(k) for successful clearance for in vitro diagnostics (IVDs), which are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home

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
Regulatory requirements for IVDs
Standards and guidance applicable to IVDs
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

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance