Clive Simon Hi Krystin, We have submitted 510K applications for devices for which we first we awarded CE Certification. The standards were the same although we reformatted the dossiers to meet FDA requirements. CE used to be easier but has become much stricter in recent years. Both FDA and Notified Bodies will engage in discussions (deficiency letters) after submission. So if you have a CE compliant device I would submit to FDA as per their guidelines. In terms of predicates make sure they are very close or you'll sweat trying to answer the questions you'll get. Good luck. Clive

Brian Dawson I highly recommend the following book published by ASQ Press: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition. Also on my required reading list, in addition to 21 CFR 820, are the preamble to the FDA Medical Device Regulation (21 CFR 820) and the Quality System Inspection Technique (QSIT) guide which are both available on the US FDA website. Section V of the preamble shows the FDA response to public comments made prior to the regulation being finalized and the explanations provide great insight as to the FDA's expectations.

Dan O'Leary It is important to note a few things. ISO 13485:2016 and ISO 9001:2015 are not relevant for devices sold in the US. You must implement the appropriate parts of the FDA regulations which include Part 801 on labeling, Part 803 on adverse event reporting, Part 806 on corrections & removals, Part 820 on quality systems, and Part 830 on unique device identification. Note of these align particularly well with the EU system.

The device classification system in the US is different from the MDD. For example the US has only 3 classes and FDA assigns the classes. For each device, you need to identify the Product Code. That will give you the specific details for the submission including guidance documents and recognized standards.

Its all available on fda's home page but I highly recommend you use consultants or get training from AAMI. It's not for free but it's better than taking the beating later on.

Hi keystin you can visit fda.gov you'll find everything as per your query.

Wow, thank you all SO much for the responses! I am excited to follow up on all the advice you have so generously provided me!

Ihab Rashad, MBA PMP Hi Krystin, check out 21 CFR part 820 on the FDA website for more information on quality system.

Dear Krystin
As Ted mentions, if your not familiar with differenties between FDA and IsSO 13485-Notified Body
Hire a consultant or get training to support you and secure the appropriate results. It's not worth gambling FDA. Cheers Torben

Dr. Joy Frestedt The process is not to "prove" the predicate and subject devices do "similar" things; rather the 510(k) regulations require clear demonstration showing the subject device has the same safety and performance profile as the predicate device and should be allowed on the US market without a PMA. Sometimes this requires clinical trial work.

Dan O'Leary For many devices, one can submit to a third-party. Many of these third-parties are also notified bodies. If they are familiar with your product, your QMS, and your company, they can provide a valuable pathway to 510(k) clearance.

Courtland Imel Kristin,
Please note that current ISO standards for testing and those accepted by FDA may be different. FDA does have a list of acceptable standards on their website. I will suggest hiring a US based consultant to act as an aid in getting your first submissions through the FDA. Using a consultant can provide some insight that you may not receive directly from FDA during the review process, especially the first few. If you like the opportunity, then continue. If you want to try it on your own, then move forward. I will say that FDA can be a little more daunting than working with a Notified Body. Good luck, Courtland

Dr. Patrick Druggan Buy the RAPS fundamentals of US regulation 7th edition

On July 11 will be a free web seminars https://www.regulations.gov/docket?D=FDA-2016-D-1495) del document 'Draft Guidance for Industry on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.'

Depending on your medical Device (class 1, class2, class 3) you may want to review California prop 65 and compare against REACH compliance.

Robert Lee MS, RAC, CQA The FDA website has a list of "Recognized Consensus Standards" that you can use to meet FDA design requirements.

I can refer you to someone, just let me know if you need it. Good Luck!

Ken Micciche Check with TUV SUD for comparison information.