When you have a great device that you need to have cleared by the FDA before you can market it in the U.S, it can be frustrating to know you might have to wait a while for a final decision to be made. The FDA are extremely busy and usually get bombarded with thousands of 510(k) submissions with each passing year, resulting in lengthy turnaround and response times.
Here are some ways that you can help your submission glide through the reviewing process as fast as possible:
Do your Research
The more you know about the 510(k) clearance submission, the better you will be able to handle the submission process. You should have a good idea about not only the requirements for your device, but the similarities it shares with the comparative device as well. Certain devices may require specific guidance documents and ISO standards that you may have to follow. Taking time to get your necessary homework done on the subject will help the process to go more smoothly further down the line.
Include All Relevant Information
Your 510(k) submission will require that you include certain details about various aspects of your device. According to Expert Briefings, one of the top reasons people experience delays in their 510(k) process is due to poor submission quality. You must make sure that you submit the essential information as required and also to submit electronic copies of the submission as a back-up.
Submit to a Third Party Company
The FDA created the Accredited Persons Program with the intention to speed up the 510(k) review process. Companies such as fdathirdpartyreview can exhilarate your FDA 510k clearance submission and save you up to 100 days of the waiting process. This means that you will receive clearance faster and you can get your device into the market quicker than if you were to apply directly to the FDA. This is definitely the most effective method of speeding up the reviewing process and is advised to people wishing to clear Class I and Class II devices in particular.
Provide Only What is Needed
Don’t bombard your submission with irrelevant information or details that are not sought after by the FDA. Don’t be afraid to ask questions and give only what is required. It is better to keep your submission as clear as possible so you don’t end up confusing the people who will be reading over and reviewing your submission. Stay focused on what matters and you will have your 510(k) submission back in no time.