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Last night I published a blog (http://www.medicaldeviceacademy.com/blog) about how to write a template for the device description section of a 510(k) submission (i.e., Section 11). As with all things I do, I have three basic tactics: use a harmonized standard or guidance document when possible For the first item, I had two documents to choose from. The first was the newest version of the refusal to accept (RTA) guidance document that the FDA made effective on October 1 (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf). The second is the GHTF guidance document for preparing a summary technical document (STED): http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n011-2008-principles-safety-performance-medical-devices-080221.pdf. The STED guidance is an international guidance, but the proposed European Medical Device Regulations (EMDR) is closely modeled after the guidance (see Annex II of the proposal for the content and format of a technical file). Some of the US requirement are redundant with the EU requirements, however, other requirements are unique to a 510(k) submission. For example, the FDA requires that you list all the components and accessories (redundant), but then the FDA wants you to specify if the 510(k) number for each of them and indicate which components and accessories are included with your submission. Sometimes you have different accessories you use in a kit, because you have certain accessories that are only approved in Europe while others are only cleared by the FDA. In these cases, I recommend a table that is split by country. Then I create another table that identifies 510(k) numbers for the devices that are going to be used in the USA. I could also create two documents, one for each country, but then I would have two document control numbers and I would have to update both versions if I change something that is common to both markets. I don’t like to do that. My final, and most important, step in writing a useful template is that I want the document to be simple. Simple documents are easier to create, edit, read–and seldom are rejected. If you have every single requirement in the guidance document in the order that it is expected, it doesn’t matter what the submission weighs. Regulators have limited resources and documents that are hard to read result in more requests for additional information. Therefore, I like to title each template with a short title and a section number that matches the 510(k) submission. I also will include a document control number in the footer so that it is a controlled document referenced in the Technical File (TF) / Device Master Record (DMR) Index. I paginate each document and I include a revision. This makes it easy to find what page the information a regulator is looking for can be found on (required by the RTA checklist and CE Marking reviewers). The revisions make it easy to create a revision history. That revision history is helpful to identify design changes quickly. I’m sure you have some tricks that you use in creating your own templates. Please share them with us. source: https://www.linkedin.com/groups/2070960/2070960-6067634444968226820 Marked as spam
 Posted by Asked on November 4, 2015 12:00 am
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Private answer
Alex Bromberg
If you are a manager responsible for such submissions, how often to you choose to hire a contractor/consultant to handle the submission process versus handling it internally? What do you see as the pros and cons of these two separate methods of handling the submission process?
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Karen Boyd, ASQ CQA
Great question, Alex. I'm curious to see what advice will come forth!
Offhand, some pros I can see with contracting the submission are to alleviate the management of devoting personal resources that may not be readily affordable and allowing a dedicated, (perhaps better-versed or experienced), professional to that task. Some cons to contracting the submission may be that the management is more closely in tune / familiar with the devices, (as their own), and perhaps the contracted work requires more resources (time) to review for accuracy and/or revision to ensure the documentation appropriately meets the company's needs. Marked as spam
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Alex Bromberg
Thank you for your insight, Karen. I think the specific contractor/consultant brought on has a big impact on those pros and cons. For example, a Sr. level contractor with 10-15+ years experience with submissions in the industry of the company in question can often streamline the process despite not having as much direct knowledge of the product itself. Knowledge of the submission process in this kind of situation trumps the experience with the product being submitted, in my opinion. But I'd love to hear other people's thoughts on this.
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Robert Forrest Rudnick, CQA
Rob (et; al):
As always a fantastic guidance on the approach you outlined. While this would appear to be logical to many in our industry, especially those with double digit years of experience, logic also eludes many when it comes time to address the task at hand. I have used this approach when involved with 510(k) submissions and can attest from experience that it works. Thank you once again for bringing to light what can be a daunting task. I always look forward to your insight and recommendations. I have yet to fall short when following what you have put out there as a recommendation but really should be taken as a prescription. Regarding the hiring of a contractor aspect, I hate to sound like I am in Marketing but it depends on a number of factors. The most critical being the experience in preparing such documents for regulated industry. I have dealt with credible auditors and trainers but would not consider them for such a task. My recommendation is to find someone with experience in successful submission work. While they may not be in a position to disclose what they have submitted or for whom due to an NDQ agreement, a brief discussion of the task and how they would approach same usually can yield positive results. Best regards, Marked as spam
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Clarisa Tate
Thank you for sharing. Like we always say, there's always room for improvement no matter how long you've been doing this. I keep my templates as simple as possible. I keep in mind that many different individuals will be looking at the submission and it's our job to make it as easy as possible for them to review the information. In this case, I like using a lot of tables especially for comparison purposes. It certainly gets to the point.
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Ron Ellsworth
Rob - Damn you're good! Seriously. I checked your posts.
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Rob Packard
Thank you for your positive comments. I sincerely appreciate it.
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Rob Packard
Companies hire contractors to solve bandwidth issues and because they are not confident they can do it alone. The first time I work with a client the are getting templates and building experience that will develop confidence. During subsequent submissions clients rely more on help wit the initial strategy and me reviewing /editing their work. A second pair of eyes is always helpful.
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