The Musical Icon Prince just passed away, possibly by an overdose. I was a fan. I had Diamonds and Pearls playing in my car’s cassette deck for about a year a while back. It is tough to classify his genre. He was pretty original.

In a not unrelated news update, the FDA appears to be showing signs of gearing up to (finally) approve/allow the Actipatch by Bioelectronics to be sold OTC (over the counter) in the USA. More on this later

This approval will ultimately be due to the never say die attitude of Andrew Whelan, the mastermind at the Bioelectronics corporation. He saved this technology by shifting the focus from the USA and its Big Pharmaceutical Company owned FDA to Europe. One advantage of Europe’s Socialized medicine (there are several disadvantages) is the drug companies have less influence on the regulatory process, since the governments there are footing the bill more so want to try to keep it cheap. Bioelectronic’s Actipatch, a chronic pain treatment which utilizes the induced magnetic field generated by pulsed electromagnetic waves to alleviate pain is certainly an effective, affordable, and easy to use system for pain management. Actipatch’s popularity in Europe has generated independent testing by prestigious institutions and increased sales of the product.

Meanwhile, the FDA in the USA has never allowed the Actipatch to be sold here. Americans, you see, take drugs for pain. This is the American Way, and it kills a lot of people each year. People notice when a famous person buys it. Prince is the FDA’s latest victim.

Prince supposedly was taking Percocets, a legal prescription painkiller. People develop a tolerance and have to start ramping up. The Actipatch could have prevented this. This is drug free treatment. There are no dangerous byproducts breaking down in your liver and kidneys.

I mentioned earlier I think the FDA is finally going to cave in to political, economic, and scientific pressure and approve the Actipatch for sale in the USA and now I will list why I think this. My evidence is somewhat circumstantial and this might be tedious if you aren’t interested in this sort of thing so bear with me Also, a true expert will doubtless be offended by my attempt at explanation. I am trying for “less is more” here. Also, if you are too exacting in your FDA terminology, relax Approval and Clearance for Marketing are distinct. I get it.

  • The Actipatch has three paths to approval
    1.  de nova-primarily for brand new technologies
    2. predicate device-basically the Patch can get grandfathered in by referencing something similar which was already approved This is tricky for the Patch because the the most similarly approved application was listed as diathermy for directed heat treatment. Basically, the predicate device got approved in 2002, but the FDA got the mechanism wrong The true mechanism is actually now called  DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT, basically So, the FDA was not letting the Patch get approved because it would not accept the original as a predicate different mechanism). The FDA recently updated the Biolectronic listing to show that they will be  accepting the original predicate for the new mechanism–DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT. This could be the FDA tipping its hand that it is lining up its ducks for imminent approval
      1. To sum, click here and look at ” Device Classification Name Look at Decision-substantially equivalent (SESE)
      2. Now, click on Statement. It references the 2002 as the predicate device!!!!!!!
      3. !!!!!!!!!!!
      4. Takeaway-this got updated DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT was not getting to use the 2002 approved device as the predicate It seems to obvious as a giveaway, but apparently the FDA is getting ready to move.
    3. There is a third route to approval, arduous and you wind up needing a prescription for the thing called the PMA route, the October OTC reclass by the FDA hopefully rules this out

So above is the first bit of circumstantial evidence I have to present Below is the second

Import Alert 89-08

This one is a bit more of a stretch, but it is a revision regulating import that popped up when I searched the FDA site with these key words- DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT

What I got out of reading this was devices are getting blocked if they lacked proper labeling. One of the previsions in the October reclass stated the devices might need additional labeling to be allowed to be sold in the USA Not banned,just need the correct labels sounds like pending clearance for marketing

Here is the buy-in: The FDA is in slightly uncharted waters here and wants to do this correctly So, they are getting what they can ready prior to the official announcement

None of these delays helped Prince of course

 

Notes:

BRAUN and the Oxford University study should materialize pretty soon as well, so Bioelectronics may have a huge month in May-2016

 

 

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