{"id":4184,"date":"2015-04-17T04:42:48","date_gmt":"2015-04-17T04:42:48","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4184"},"modified":"2015-04-17T04:42:48","modified_gmt":"2015-04-17T04:42:48","slug":"510k-workshop-at-10x-conference","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2015\/04\/17\/510k-workshop-at-10x-conference\/","title":{"rendered":"510(k) Workshop at 10X Conference"},"content":{"rendered":"

\"\"<\/a><\/span>On May 4, 2015 in San Diego, I, Leo Eisner<\/a><\/strong>, am presenting along with 2 other experts in the field on the 510(k) process. The 10X Conference<\/a><\/strong> is from May 4 – 6, 2015 at the Hilton San Diego Mission Valley.\u00a0<\/span><\/p>\n

It would be great to meet you at this workshop or the entire conference and learn something new at the same time. \u00a0(See end of post for discount info)<\/span><\/p>\n

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.<\/span><\/p>\n

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). \u00a0He is currently asking for feedback which areas to focus on and you can send him an rob@13485cert.com<\/a><\/strong> with your suggestions too. \u00a0His current plan is to discuss:<\/span><\/p>\n

    \n
  1. provide an overview of the submission requirements with some focus on 510(k) format and contents (Section 2),\u00a0<\/span><\/li>\n
  2. review of Indications for Use (Section 4),\u00a0<\/span><\/li>\n
  3. review of 510(k) Summary (Section 5),\u00a0<\/span><\/li>\n
  4. review of Device Description (Section 11),\u00a0<\/span><\/li>\n
  5. review of Substantial Equivalence (Section 12),\u00a0<\/span><\/li>\n
  6. review of Performance Testing (Sections 18-20)<\/span><\/li>\n<\/ol>\n
    I, will be discussing the following topics. \u00a0These topics apply to general medical electrical equipment, medical software and also wearables:<\/span><\/div>\n
    \n
      \n
    1. Refuse to Accept (RTA) Process and FDA guidance<\/span><\/li>\n
    2. Electrical Hardware Aspects of a 510(k) – Section 17 which will include areas such as:<\/span><\/li>\n