Message Image  

Latest Discussions

  • Since you are not planning to do any submissions until November, don't worry about 2016 - start with requesting Small Business status for 2017. You have to renew this each year. In theory, you can submit for 2017 status before October 1 - and if you have a submission planned for October, it makes sense. However, I have found that occasionally creates...

  • Given the furor around hip implants and the face that you will be submitting data to show compatibility and other technical data, and making marketing claims around compatibility of different devvices, I would say a Traditional is more appropriate. You can try a 510(k), but my money is betting they would convert it to a Traditional anyway. Ginger...

  • Hi Harsha, SInce you are not submitting your 510(k) until November, and assuming that you have no devices in the market now, you should disregard the 2016 guidance. The FDA Fiscal Year runs from October of the previous year until September 30 of the named year, e.g. October 1, 2016 until September 30 2017 is the 2017 Fiscal Year. Therefore,...

Most Active Members