RTA – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Fri, 17 Apr 2015 04:42:48 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png RTA – Eisner Safety Consultants https://eisnersafety.com 32 32 510(k) Workshop at 10X Conference https://eisnersafety.com/2015/04/17/510k-workshop-at-10x-conference/?utm_source=rss&utm_medium=rss&utm_campaign=510k-workshop-at-10x-conference Fri, 17 Apr 2015 04:42:48 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=4184 On May 4, 2015 in San Diego, I, Leo Eisner, am presenting along with 2 other experts in the field on the 510(k) process. The 10X Conference is from May 4 – 6, 2015 at the Hilton San Diego Mission Valley. 

It would be great to meet you at this workshop or the entire conference and learn something new at the same time.  (See end of post for discount info)

Allison Komiyama, a former FDA reviewer, will be sharing an actual 510(k) that was redacted with us. This will give us a great perspective from the reviewer viewpoint and show us what types of comments and requests for additional information are made.

Robert Packard, a regulatory and quality systems consultant, with lots of 510(k) experience, will be sharing some of his insights into putting a 510(k) together and will focus on several of the more important sections of the 510(k).  He is currently asking for feedback which areas to focus on and you can send him an rob@13485cert.com with your suggestions too.  His current plan is to discuss:

  1. provide an overview of the submission requirements with some focus on 510(k) format and contents (Section 2), 
  2. review of Indications for Use (Section 4), 
  3. review of 510(k) Summary (Section 5), 
  4. review of Device Description (Section 11), 
  5. review of Substantial Equivalence (Section 12), 
  6. review of Performance Testing (Sections 18-20)
I, will be discussing the following topics.  These topics apply to general medical electrical equipment, medical software and also wearables:
  1. Refuse to Accept (RTA) Process and FDA guidance
  2. Electrical Hardware Aspects of a 510(k) – Section 17 which will include areas such as:
    • Recognized Consensus Standards and Guidance 
    • What’s the status of these Standards
    • Tips on filling out Standards Data Report for 510(k) form 3654
    • Home Use Environment Guidance Document
    • Mobile Medical Applications Guidance
    • General Wellness Draft Guidance
    • Accessories Draft Guidance
    • IEC 60601-1-2:2014 (4th ed.) and the HUGE Impact it will have on your devices
  3. Software Aspects of a 510(k) – Section 16
  4. Cybersecurity Guidance

To reserve a spot at the conference or just the workshop contact Joe Hage at jhage@MedicalDeviceEvents.com and he will provide you a with special rate if you mention Eisner Safety Consultants referred you to him.

If you want to learn more about these Wearable Guidance documents, Medical Electrical Safety Standards, or the 510(k) process, meet me at the 510k workshop in San Diego on May 4, 2015 as part of the Medical Device Group 10x Conference. Two other consultants on the Eisner Safety Consultants team will teach the workshop: Allison Komiyama and Robert Packard.

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