FDA Approval: What it Takes for a Product or Procedure to get FDA Approved

fda approved stamp

It gets a little frustrating covering products and procedures that are offered in other parts of the world but are still waiting for FDA approval in the U.S. Actually it makes me CRAZY, so I decided to do a little reconnaissance to find out why.

What I’ve found is surprisingly interesting. The FDA has always been a vague reference to me, but now that I know the whole story, I can follow new beauty products and procedures as they go through the process instead of taking advertisers word for things and wasting valuable time in the process.

So exciting!

The Birth of the FDA (U.S.Food and Drug Administration)

When I was writing about ATX-101, it wasn’t yet approved for sale in the U.S., but had been used in other countries for years. When I covered Cellfina for cellulite, same thing and, shoot, Frotox is still not available in the U.S. because it’s not FDA approved for use on forehead wrinkles.

So what gives? Why do we even have an FDA?

It began with the Biologics Control Act of 1902, which was formed after the distribution of a contaminated smallpox vaccine and diptheria antitoxins caused tetanus outbreaks, killing several children.

This act was the first legislation calling for Premarket Approval, which is the bedrock of the FDA. This meant that before a drug can even be marketed, the federal government must first approve the process as well as the facility producing the drug.

Four years later, in 1906, Upton Sinclair wrote a novel called ‘The Jungle’ that talked about the putrid conditions of the meatpacking industry. At one part in the book, a workers falls in a can of lard and is ground up by accident. Yum.

"The Jungle" by Upton Sinclair

“The Jungle” by Upton Sinclair

This was about the same time that the government formed the The Poison Squad, that was comprised of  human volunteers who ingested things like formaldehyde, boric acid, food colorings and preservatives in concentrated forms for testing.

Human testers! Who would take that job?? It sounds archaic, but really, is it all that different than what we do to animals? But that’s another topic. You can read more about the Poison Squad in this super interesting article in Esquire called The Poison Squad: An Incredible History.

Not surprisingly, the guys in the Poison Squad started to get sick and that, coupled with the attention of the book ‘The Jungle‘, led to the Pure Food and Drugs Act of 1906.

Eight years later the government passed The Harrison Narcotics Act of 1914, placing a tax on the sale of opium, as well as limiting the amount of narcotics that doctors could prescribe. Thousands of doctors were imprisoned for prescribing unnecessary narcotics. Good times.

The combination of these three acts led to the Food, Drug and Cosmetic Act of 1938, also called the FDA. The FDA wouldn’t get serious about the pharmaceutical end of things until Massengill released the sulfa drug Sulfanilamide.

Although it underwent testing, they failed to test the liquid form (the equivalent of what we now call ‘antifreeze’) which ended up killing 107 people.

Mostly children.

Events Leading to the FDA of Today

fdaThroughout the years, there have been many amendments to the Food, Drug and Cosmetic Act of 1938, that culminated in the stringent policies of the FDA today. But the most tragically important ones were the Kefauver-Harris Amendments.

Maybe you’ve heard of the thalidomide babies?

In 1957, a German pharmaceutical company developed a drug called thalidomide that alleviated the symptoms of morning sickness in pregnant women. In 1960 the drug was submitted to the FDA for approval for sale in the U.S.

By 1962, after being marketed and prominently sold in 46 countries, it was discovered that thalidimide caused  horrific side effects to the fetus, such as stillbirths and truncated limbs that looked similar to ‘flippers’.

(pretend there’s an image of that here – it was too sad to see)

Luckily, we weren’t selling it in the U.S. yet.  Dr. Frances Kelsey, with the FDA, had withheld the drug for approval, calling for additional investigation into the neurological effects of the drugs. This close was positive reinforcement for the FDA.

Kelsey received a distinguished Federal Civil Service Award and shortly thereafter came the Kefauver-Harris Amendments of 1962, which called for more strict regulations on the Premarket Approval of drugs in the U.S.

Since then there have been many amendments addressing animal drugs, infant formulas, supplements, and medical devices, evolving into the FDA that we have today. You can read more about these amendments at FDAReview.org.

FDA Approval Process

So, what exactly do pharmaceutical and medical companies have to do to get a product or device ( or procedure using a device) approved though the FDA?

For Drugs

To get permission to market a new drug (ex. Botox and ATX-101) you need a PMA (Premarket Approval). To be granted approval, pharmaceutical and medical companies must follow certain steps.

Step 1:

Conduct laboratory and animal tests to prove the drug is safe for human testing.

Step 2:

Submit an IND (Investigational New Drug Application) for approval to perform clinical trials on humans. Once the approval is granted, human trials begin and are broken down into 3 phases:

  • Phase I:  When researchers test a new drug or treatment, in a small group for the very first time, to check dosage and safety. Usually they use a placebo to confirm that the drug actually works.
  • Phase II: When the drug or treatment is given to a larger group (usually 25-100 participants) to confirm it’s safety and effectiveness. No placebo is used in this phase so the treatment is actually given to all of the patients in the study.
  • Phase III: When the drug or treatment is given to large groups of people to confirm it’s effectiveness, check out the side affects, and compare it to treatments already on the market.

Step 3:

The company submits the clinical trial results to the FDA’s CDER (Center for Drug Evaluation and Research) in a NDA (New Drug Application) at which time the drug is reviewed by a team of statisticians, physicians, toxicologists, pharmacologists, chemists and other scientists.

If it is found that the benefits of the drug outweigh the risks, the drug is approved for sale. Now the product can be sold, but it’s not the end of the FDA’s role in the process.

Step 4:

After the product is marketed or sold, the FDA watches it through systems such as MedWatch that monitors suspected adverse reactions. This is also referred to as Phase IV of the clinical trial:

  • Phase IV is done after the FDA approval and the drug or treatment is marketed to the public so that it can confirm the drug’s effectiveness in various populations as well as any side effects of long term use.

Step 5:

If there are unexpected contraindications, the FDA may make it necessary to add a warning to the label and publish safety recommendations. If it is discovered, at this phase, that the drug is more harmful than beneficial, the drug can be pulled from the market and the approval will be withdrawn.

Pretty in depth stuff. It usually takes about 10 years for a drug to be developed and approved through the FDA.

For Medical Devices

The protocol for getting medical devices FDA approved is a little different and it varies depending on the classification of the device. Here’s how it goes:

Step 1:

First they must determine the classification of the device. There are 3 classifications for medical devices according to the FDA –

  • Class I : Products that pose little or no risk such as elastic bandages and enema kits.  Most are exempt for filing a PMN (Premarket Notification / 510(k)) or PMA (Premarket Approval).
  • Class II : Devices that have little or no risk, such as powered wheelchairs, pregnancy tests, and some aesthetic devices like CoolSculpting, Cellfina and laser hair removal. Most require a PMN.
  • Class III: Devices that sustain or support life, that are implanted, or are devices that support life. Examples are pacemakers and breast implants. It’s interesting to know that some dermal fillers are also in this class. Most require a PMA .

Step 2:

After defining the classification, the company still has to check what they have to file – a premarket approval, premarket notification / 510(k), or if the device is 510k exempt. An easy way to find this out would be to go on the Product Classifications Database.

Rule of Thumb: All Class III devices and some Class II (mainly if they’re new technology) require PMA’s.  If the product can’t be found on the database then it will need a PMA as it has never been approved and needs to start from scratch.

But most likely, if a device is Class II, it will only require a PMN, which is also called a 510(k). Unless a device is categorized as 510(k) exempt, the appropriate paperwork must be filed before the product can be marketed.

If the item is 510(k) exempt, then the company is free to market and sell the product, but will still be monitored by the FDA for complaints or side effects.

So, if you see an ad for a new device then it has definitely,  been PMA approved or PMN cleared. If it is for sale you can feel secure in the knowledge that it has received FDA approval and therefore is safe.

Is your head spinning yet?

Step 3:

a) If a PMA is required –

The manufacturer must submit a document with the following information:

  • Technical sections with all of the clinical and non-clinical studies and investigations backing up the effectiveness and safety of the device.
  • Microbiology
  • Wear
  • Shelf Life
  • Immunology
  • Animal and human tests.

(Basically like steps 1-3 in the ‘For Drugs’ section)

b) If a PMN (510(k) ) is required –

Medical Devices that don't requiire PMA require a PMN (Pre-market Notification) in the form of a 510K

PMN (Premarket Notification) aka 510(k) for CoolSculpting

Substantial equivalence must be demonstrated. This means that:

  • the device has the same intended use and the same technological characteristics as a device that is already approved and being sold on the market OR
  • the device has the same intended use, but different tech specs, at which point the differences must be outlined and proven so that they don’t raise new questions of safety and effectiveness, and that the device is at least as safe and effective as the legally marketed device.
Premarketing Notification Flow Chart

Premarketing Notification Flow Chart

From the time the document is submitted it takes at least 180 days for approval. If the document has missing info or is not in the correct format, then it must be resubmit and the clock starts all over again.

So for example, if the Ulthera wanted to market their product for tightening arm skin, since it’s already approved for face, neck and decollete, they would only need to file a premarket notification – not a premarket approval. Make sense?

Step 4:

a) If a PMA was required and submitted, the FDA takes about 180 days to either approve it OR approve it with conditions called postapproval requirements. Postapproval requirements include such items as labeling, packaging, batch testing, studies or any other requirements the FDA sees fit.

The postapproval must be answered within 60 days or approval can be rescinded.

b) If a PMN was submitted, the FDA can approve it or send an Additional Information (AI) Request which would put the approval on hold and must be responded to within 180 days or else they have to submit the premarket notification again and start all over.

Cost of FDA Processing

The FDA relies heavily on fees so it’s no wonder they are so steep. For a new prescription drug it runs $2 million. For medical devices $250k. A product can go a faster route by filing as Biosimilar, which means that the product is interchangeable with another product already on the market. It’s the PMN/510(k) route and runs about $2 million.

Before I leave you, there is one more thing that I need to cover and it’s important.

The Difference Between Being FDA Cleared  and FDA  Approved

When your reading about a new product or device you will hear either that it has been FDA ‘approved’ or FDA ‘cleared’. There’s a distinct difference between the two:

FDA ‘Clearance’

If a product or device has received FDA ‘clearance’ or has been FDA ‘cleared’, this simply means that it has been given the thumbs up to begin the 501(k) or Premarket Notification process and that the technology has been previous approved but for another use.

Ex. In May 2015, Sculpsure was given FDA ‘clearance’ for the non-invasive removal of abdominal fat. Since the product had already been approved for use on the flanks, all they needed to do was prove that it could be used on the abdomen. So, instead of going through the whole premarket approval process, the only had to file a510(k) / Premarket Notification in order to be allowed to market the product as such in the U.S.

As you know from above, the 510k process takes about 180 days to be approved, so if you’re trading the stock you will know to keep an eye out for the approval within the next 6 months (and most likely enjoy a nice little spike). Or if you’re planning your yearly beach vacay, you know that if you postpone for a 2 or 3 seasons, you’ll be rocking la playa with some toned abs after your Sculpsure treatment. 🙂

FDA ‘Approval’

If a product has been FDA ‘approved’ you know that it is available for marketing and should hit the market shortly thereafter (assuming the manufacture was prepared).

So there you have it, everything you need to know about the FDA process. A short message to the FDA: HURRY UP WITH MY FROTOX!!!


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