Your 510(k) Submission: The Basic Statistics FDA Needs to See

Presented by Steven Walfish; Thursday, February 8, 2018; 1:00pm – 2:30pm EST (GMT -5)

YOU know your new device is substantially equivalent to one already allowed on the market AND it's at least as safe and effective as the predicate product. Now, you have to convince FDA that you’re right – and that means your 510(k) must include the appropriate statistics.

Statistical elements for product submissions require close attention beginning at the design stage and continuing through hypothesis testing and the manufacturing of finished products. You may not be the statistician…but it's important that you familiarize yourself with the data required and the statistical methods used in your 510(k).

On Thursday, February 8, 2018 at 1:00pm EST, join FOI and Steven Walfish for a 90-minute audio-format teleconference to examine the techniques commonly and successfully used in premarket notifications for medical devices. Combining a basic introduction to how statistics are used in actual 510(k) submissions and examples of common mistakes, this presentation will offer insight into the considerations that go in to selecting and applying statistical methods.

You’ll learn to judge when a novice can effectively handle the necessary statistics using off-the-shelf software...and how to recognize when an experienced statistician is needed.

No previous statistical analysis experience is necessary to benefit from this presentation -- just a desire to learn. (If you’re a statistician already, encourage colleagues from other departments to attend to make it easier for everyone to understand the data you need and the rationale underlying your analyses.)

Topics to be Addressed Include:

You'll Also Receive:

Medical Device Professionals Who Will Benefit Include:

(Note: This presentation is not intended for experienced statisticians.)

About Your Presenter:

Mr. Walfish is Principal Science & Standards Liaison in the Global Science and Standards Division at United States Pharmacopeia (USP), where he is responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish joined USP after serving as Principal Statistician at BD in Franklin Lakes, NJ and Statistician at GE Healthcare in Waukesha, WI. In addition, Steven is Founder and President of Statistical Outsourcing Services, a consulting company established to provide statistical analysis and training to the drug, device and biologic firms.

Mr. Walfish has been an invited lecturer at many industry meetings, and is also a regular contributor to journals serving FDA-regulated industry. For additional information on his background, or to contact him with questions about this presentation, please consult his website at


In your office, conference room – or anywhere else you are!


Thursday, February 8, 2018; 1:00pm to 2:30pm EST (GMT -5)

Registration Options:

You can register for any of these options below. If you have questions or prefer to register by phone, call us at +1-301-975-9400.

Standard Order...Listen Live!

Your first toll-free (even if international) dial-in is $449 and covers one telephone connection – put the teleconference on your speakerphone and let everyone present listen for one price!

FOI Services will provide handouts and dial-in information for each connection ordered 1-2 business days before the teleconference.

Add extra connections to your Standard Order for only $89/line! Now you can affordably let colleagues in scattered offices, at home, on the road, or anywhere else listen live, too! When you place your Standard Order for a teleconference at the regular $449 price, you now have the option of adding more lines to the same invoice for only $89 per connection – just follow the directions online or call us at +1-301-975-9400! (Note: To qualify for this discount, extra lines must be ordered at the same time as a Standard Order.)

Can’t attend? Try the Audio Package for $449. The package includes online delivery of an mp3 file of the entire presentation, including the question and answer session, as well as all of the handouts. (Please allow one week after the event date for delivery.)

Listen Live..AND get a 50% discount on the Audio Package! If you order a live registration and the Audio Package for the same teleconference, you’ll receive a 50% discount on the audio. To order both the live registration and the audio package, register below, and you will be given an opportunity to add the audio as well. Or if you prefer, you can always phone FOI at 1-800-654-1147 (outside the U.S. and Canada call +1-301-975-9400).