Long ago and far away, clearance of a US device with FDA did not depend upon conformity to a standard. FDA, believe it or not, didn’t recognize “voluntary” standards and according to regulation, only FDA could issue a “performance” standard. Some years back, the ice broke and certain standards for evaluation of a device became “recognized”. One of the earliest was for the evaluation for biocompatibility (ISO 10993 Part 1), which took the place of the old “tripartite agreement”; and now we have a deluge of standards to consider for any new medical device. Soon the trickle became a roar and regulatory bodies began to see the wisdom of recognizing certain “peer reviewed” standards.
In the US, the FDA began to require that in order to receive 510(k) clearance, that is to say, to be found “substantially equivalent”, the sponsor’s candidate device had to comply with the same standard in the same way as the predicate device. When the European Community adopted a single system for acquiring the CE Mark for medical devices, we saw the global recognition of the value of standards. (ESSENTIAL REQUIREMENTS list constitutes a backbone requirement to market a product in the EU. We can explain this further if you are seeking the CE Mark.)
Do you know how to find the standards which apply to your product? Are you planning a new medical device submission to FDA but don’t know which standards your device may be required to meet? For US FDA applications, we can search the FDA website to locate an applicable standard recognized by FDA for a particular product. There are two tried and true methods: Look at the predicate 510(k) application, and search the FDA database by the “procode” (the three-letter classification designation for each product type.) It is always wise to confirm a standard is or is not recognized by FDA, and if so, are there exceptions to the recognition. Exceptions to recognition can be very important to you when applying a standard as part of a submission requirement. It is also important to double check the VERSION of the standard that FDA recognizes. Many of the FDA guidance documents identify one or more standards. (Many folks do not realize that the US FDA does not “recognize” ISO 13485!)
Are there too many standards to keep up with now? We think so, but it is a necessary evil since adoption of standards has enabled US medical device companies to offer products acceptable to worldwide markets. The difficulty may not be the actual number of standards, as much as it is the number of “parts” to a standard and the revision level adoption that varies from country to country. As a general rule, the EU adopts international standards more quickly than the US FDA, and in some countries a US Standard may not be recognized in lieu of an international standard. Although not often, it does occasionally occur that an IEC or ISO standard will differ from the US-adopted version issued by AAMI or ANSI. ASTM standards may not be the first choice for EU ESSENTIAL REQUIREMENTS as a first line standard if an international standard on the same topic is available.
How can you find reputable laboratories and testing facilities to conduct the standards testing required for your device? It is still possible to conduct your own standard compliance testing. It is not necessary in all cases to work with a certified laboratory. However, the more sophisticated the testing, such as for electromagnetic compatibility, electromagnetic immunity and electrical safety, the more likely you will need to work with a certified lab. Certification is not the only criteria for finding a good laboratory for the necessary testing. Some labs can offer additional certifications beyond just providing testing results. Some labs are happy to run the testing, but their reports don’t satisfy the FDA’s requirements for reporting. We can work with you to ensure you have the lab you need, that they run only the testing that you need, and that their reports will meet FDA requirements.
How do I complete the 3154 and 3654 Forms for my 510(k)? One of the first steps in preparing your new product application to the FDA is to complete the 3514 form. This form provides to FDA the basic information they need to file your submission. On the last page of this form, FDA requests that you list all of the standards to which you make reference in the submission. It is very important to consider this list well before you prepare the submission. If you must comply with a requirement in a standard and you’ve not begun that assessment, such an oversight can cost you time as well as money to try to catch up with the FDA’s 180 total clock for review. On the 3514 Form you will notice the FDA wants “version” and “date”. Sometimes you may not know the version, so at least try to know the date of issue. Provide as complete a title as possible. But your job has only now started. For each standard listed here, you will need to complete a 3654 Form, and this can get tricky.
We recommend you start thinking about completion of this form for each standard BEFORE you begin to apply the standard to your device. You will need to check the FDA website for recognition carefully because the questions on the form will ask about the scope of recognition of the standard. Also, FDA wants you to be aware of whether or not the standard states an “acceptance criteria”, and if so, you will need to include that in the standards report. If the standard does not have an acceptance criteria you need to include the results of any compliance testing in the 510(k) and be ready to defend the acceptance criteria that you establish.
Some standards have an option A and B for compliance with the standard, or even more refined options on how to conduct an evaluation. Be sure your laboratory is aware of such distinctions and include this option discussion in the report. Identify any deviations and exclusions very carefully. And, you need to be aware if any FDA guidance applicable to your product discusses this particular standard. There are a few instances where the guidance will describe certain exceptions or special requirements associated with the application of the standard to your device.
Now for the good part: depending upon how you answered the questions on the first page of Form 3654, FDA asks you to provide detail and justification accordingly. If you have addressed any deviations and options in the formal report, you need not put the details on page two. You can reference the page and paragraph in the report where the information can be found.
Standards for medical devices unquestionably improve the overall quality of medical devices, but development teams can get discouraged looking at a long list of applicable international and national standards, and all the details that go into claiming conformity to standards. We’ll help you see your way through the tunnel. Let us shine a light on your standards.