FDA approval thoughts: Here is my assesment on where we stand. On June 16 the company announced that ".. For its Allay menstrual pain relief product, BioElectronics has formally requested the change of its application from a 510(k) to Section 513(f)(2) de novo review". This is very significant. If you read the FDA guide lines on "Request for Evaluation of Automatic Class III Designation (de novo process), fully and carefully here is what you learn:
(1) The FDA has issued a NSE (Not-substantially Equivalent) letter to the company. Joe Noel has acknowledged the receipt of the NSE letter. This means the 510K review by FDA for the Allay product is complete. A post by a person called Mike (Thanks!) on Joe Noel's web site triggered this acknowledgement and also my analysis of the situation.
(2) A de novo request is to be sumbitted within 30 days of the NSE determination.
(3) In the NSE letter or during the 510K review process, FDA indicates to the requester if they (FDA) thinks
(a) the devices are low risk and thus are appropriate for class II/class I classification through the denovo process; or
(b) if they think there are significant unresolved safety and efficacy issues; or
(c) if the FDA considers the device to have significant risk and class III designation is approriate in which case a premarket approval (PMA) request should be filed.
The fact that the company has filed a request for Evlauation of the automatic class III designation means that (a) is the case and (b) and (c) are not true.
(4) FDA is required to respond within 60 days of the filing of the de novo request, which will be mid-August.
Now, I dont understand why the company is not publicizing these facts. In other words, I surmise that they have had communication from the FDA which has led to the filing of the de novo request. These communications should have clearly indicated that FDA considers the devices to be low risk and without significant unresloved safely and efficiacy issues.
I posted a message to Joe Noels website and he said he would bring these questions to Andy Whelan but have not heard back about it yet. I am still waiting.
Can I ask people on this forum to look at the FDA guide lines and the company's press release and post your comments and thoughts.
In summary it seems that class II designation for Allay is round the corner (mid Aug). Once that happens the rest of the devices will get the same classfication using Allay as the predicate (they essentially the same).
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