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The Food and Drug Administration (FDA) is under the United States Department of Health. It’s a regulatory agency mandated to ensure that health and health-related consumer products are safe, can deliver their expected results, and are made of good quality. Since its publication on March 20, 1997, the Electronic Records and Electronic Signatures regulation has encouraged voluntary submissions to the FDA.
That being said, you can already tell that the FDA approval process will not be easy as pie, just like filing a US patent. Fortunately, we’ll be going over the nitty-gritty details on the FDA submission process for 2022. We’ll also be giving some tips that might come in clutch when you hand in your FDA submissions.
If you’re ready, let’s go!
FDA Approval Process
Knowing the ropes will surely be beneficial when applying for a new product to the FDA. Unlike applying for a Limited Liability Company or LLC which involves eight simple steps, the FDA approval process consists of five chunky steps.
- First, you should have all the necessary proof and test results of your product’s concept and efficacy.
- Next, the FDA will review your submission and evaluate its benefits versus its risks.
- Once the agency determines that your product has significantly more positive contributions than negatives, you can move on to conducting clinical trials.
- You should send these results to the FDA for another round of review
- Await final approval.
Keep in mind that even after your product has been FDA-approved, it will still be under the surveillance of the regulatory agency. This ensures that your product is still safe, delivers desired results, and doesn’t decrease in quality over time. So, essentially, the fifth step is an ongoing process.
FDA Submission Types
The length of the approval process and the extent of research for an FDA application are dictated by your product’s submission type. Broadly, the two categories of FDA applications are for clinical investigations and marketing approval. Each of them will need an in-depth discussion for their approval processes, but here’s a brief description of the FDA submission types.
The 510(k), also known as premarket notification submissions, are for general medical devices. Each submission of this type is reviewed by the Office of Product Evaluation and Quality or OPEQ of the FDA’s Center for Devices and Radiological Health or CDRH.
2. De Novo
The newest submission type, De Novo, is for digital health products such as Software as a Medical Device (SaMD) and other Artificial Intelligence or AI-operated medical devices. Its effective date of implementation was last January 3, 2022.
3. Pre-Market Approval (PMA)
Medical devices that are developed to support or sustain human life are categorized as Class III devices. These devices require pre-market approval or PMA. Since these products can spell the difference between life and death, the PMA device marketing submission is considered the hardest to get an approval of.
If you’re unsure of how your product will perform when it’s released to the market, you can opt for a pre-submission. This type of application is more of a consultation with the FDA. The goal here is simply to get feedback before you fully commit to any of the submission types suitable to your product.
5. Investigational New Drug (IND)
An Investigational New Drug or IND is classified as either commercial or non-commercial. The sole IND under the non-commercial or research category is the Investigator IND. Alternatively, the emergency-use and treatment INDs are considered for commercialization
We’ll be doing an in-depth discussion on the FDA’s IND submission process right here on Hustlehackers, so feel free to subscribe to get notified.
6. New Drug Application (NDA)
Once you’ve proven that your IND has more potential benefits than health risks, you can move on to filing a new drug application or NDA. In a way, your IND submission serves as a pre-assessment for this submission type.
7. Over-the-Counter (OTC) Drugs
If you’re thinking of developing an over-the-counter (OTC) drug, it would be best to know about OTC monographs. This is rather like a recipe book with all the ingredients and formulations used to develop the OTC drug. If your product components fall within the acceptable ranges stated on the monograph, you’ll no longer have to request an FDA approval.
8. Abbreviated New Drug Application (ANDA)
An ANDA or abbreviated new drug application is intended specifically for generic drug products. These products are “abbreviated” because they follow a shorter route in the FDA approval process. Instead of submitting pre-clinical and clinical trial results, proponents of this new drug need only provide evidence that their product’s performance is comparable to that of an already existing branded drug.
9. Biologic License Application (BLA)
As the name implies, the BLA or Biologic License Application is dedicated to biologic products, or anything related to biology. A very popular example of a biological product is a vaccine.
510(k) Submission Process
There are about 3,000 510(k) applications to the FDA per year. Some speculate that the number of applications has significantly increased thereby resulting in a longer processing time for submissions. But the truth is, it has taken around 145 to 165 days to get an FDA approval since 2013.
Here’s how the 510(k) submission process goes.
1. Account Creation and Acknowledgement Process
Since applications to the FDA are done electronically, the first step would be to create an account on the FDA Electronic Submissions Gateway or ESG. Once you’ve logged in, submit an eCopy of 510(k).
The CDRH can receive the submissions, as well as the Document Control Center (DCC) of the Center for Biologics Evaluation and Research or CBER. They will assign a unique, six-digit K number with its first two digits referring to the calendar year of submission. While the final four digits determine the designated submission number for that year.
So, if you submitted last January 2022, your K number may look like this: K220001. But before your submission gets acknowledged, you still have to pay the user fee and ensure that you submitted a valid eCopy of your 510(k). Failure to clear any of these will prompt the DCC to send out a Hold Letter until you’ve addressed these verification concerns.
Once you’ve finally cleared them, the DCC will email you an Acknowledgement Letter for your 510(k) submission, along with your unique K number. Keep in mind that the purpose of this document is only to acknowledge the receipt of your submission and is not the actual marketing clearance letter.
2. Acceptance Review
The DCC only handles the acceptance of submissions. Reviewing them is a task spearheaded by the Lead Reviewer, which is another division under the FDA. The regulatory agency is very transparent with how they assess the submissions to be accepted or rejected. You can access their Acceptance checklist and Refuse to Accept (RTA) Policy for 510(k) to have a better idea of how your submission will fare during the review. Details of the acceptance review will also be emailed to you for documentation purposes.
Once the review is concluded, your 510(k) submission will either be:
- Accepted for substantive review
- Not accepted for substantive review
- Under substantive review (if the FDA fails to finish the review within 15 calendar days)
In the event that your 510(k) was refused, it will then be put on RTA Hold. You’ll be given 180 days to address the reviewer’s issues and concerns about your 510(k) submission. Only if they find that the deficiencies they’ve listed have been fulfilled and that there are no other grounds for refusal will they accept your submission. Failure to commit to the 180-day RTA Hold deadline is equivalent to a 510(k) application withdrawal.
3. Substantive Review
The Substantive Review puts your 510(k) submission under microscopic lenses for a more in-depth and comprehensive evaluation. This step usually takes 60 days and can either lead to an Interactive Review or a request for Additional Information.
The difference between these two substeps is the length of time that it will take the 510(k) proponent to resolve outstanding deficiencies in their submission. If you can clear them within 90 FDA days as per the Medical Device User Fee Amendment (MDUFA) of 2012, you will be able to proceed to the next step sooner.
But if the Additional Information that the FDA requested will take longer to complete, then so will your application process. It’s important to always ensure that you’re submitting valid eCopies of all supplemental information. You’ll be given an additional 180 days to clear any deficiencies and provide the rest of the information needed. Otherwise, your application will also be considered withdrawn from the system.
4. 510(k) Decision Letter
After the painstaking process of preparing and submitting all the necessary requirements and any additional information, the final step would be to wait for the 510(k) decision letter. Your 510(k) submission can either have substantially equivalent (SE) or not substantially equivalent (NSE) findings.
If you received an SE decision, it means that the FDA has cleared your 510(k) for the market and has been included in their database. Otherwise, an NSE means you will have to submit again, after doing more research and tests on your product.
There are also cases when the FDA fails to reach a decision within 100 days. If this happens, you will be sent a Missed MDUFA Communication about the remaining deficiencies and target date completion. If you are able to comply with its contents, chances are high that your 510(k) submission will also merit an SE decision.
Timeline of Communication with Applicants during the Review
For a better visual of how long the process usually takes, here’s a timeline of communication between the FDA and its 510(k) applicants.
Reasons Why Your Approval is Delayed or Denied
As a regulatory agency, the FDA has every right to deny or delay an application that is deemed unsafe, pretentious, and of poor quality. This might sound subjective, but the FDA and its divisions always cite technical and scientific reasons for why and how they came up with their decisions.
They give their applicants ample time to address their deficiencies, too. New deadlines are set after the proponent receives the communication of request for additional information and other details for clarification. So, even if your application gets delayed, you can still work on the deficiencies until you finally get that SE remark.
Medical Device Approval Process
The medical device approval process deserves a whole article for itself. But here’s a flowchart to give you a general overview:
Medical Device Critique
While the FDA strives to provide science-backed decisions, there are still instances when they permit the use and market release of medical devices prematurely. This is because some of the applications are only based on the results of one clinical trial when it should have been two or more. Such a dilemma is extremely crucial for high-risk medical devices that can spell the difference between the life and death of an individual.
Kinds of Medical Device Apps
There are three broad categories of medical device applications.
|Medical device app||Submission Type|
|Low- to moderate-risk||Pre-market notification of the 510(k)|
|High-risk (Class III)||Pre-market approval (PMA)|
|Humanitarian||Pre-market approval (PMA) minus the effectiveness demonstration|
You Might Ask
How long does FDA submission take?
Depending on the type of submission, the FDA submission and approval process can be as short as one week to as long as a few months.
How long does a 510(k) submission take?
Most 510(k) submissions take around 145 to 160 days. But if we’re to use the FDA communication timeline with applicants during the review, it’ll take around 165 days. This duration doesn’t take into account the added days for RTA Hold and Additional Information requests.
Is it hard to get FDA approval?
Yes, it is hard to get FDA approval. Since the FDA handles products and devices crucial to the health and overall well-being of humans and animals, it has to assess every product thoroughly and carefully. It will not be an easy feat to get approval, and it will take some time.
What is FDA clearance vs approval?
An FDA clearance implies that a product was able to demonstrate substantially equivalent results with an already existing product in the market. On the other hand, an FDA approval suggests that the product has significantly more beneficial effects than risks to the general public’s health and safety.
How strict is the FDA?
The FDA is very strict. The percentage of approved applications to the FDA is still significantly low for high-risk drugs and devices. On average, FDA only approves around 40 novel drugs annually, while only 2% of medical devices have been approved since 2016.
Who is required to register with the FDA?
Drug manufacturers, repackers, or re-labelers, both domestic and foreign are required to register their products and businesses with the FDA. The same goes for businesses involving medical devices.
Not gonna lie, you’re a champ for reading through this very informative article about the FDA submission process. While we were only able to cover the 510(k) submission process in full detail, we hope you now have a better understanding of how the FDA approval process works.
Hopefully, it’ll seem less daunting now because we’ve provided you with the notes that you need. But it wouldn’t hurt to double-check your submissions and file attachments just in case you missed something.
So, are you ready to get that 510(k) application in?