What would the impact be if you could shave 30 days or more off your FDA medical device approval timeline? How much sooner could you bring your life-changing device to market?

In the medical device industry, your ability to design, manufacture, test, and release your device quickly can literally mean the difference between success and failure for your business. Any delay is costly and can set you back significantly.

One of your biggest obstacles is FDA approval.

The FDA’s primary responsibility is to the patient. They can’t skip checkboxes or rush their process — no matter how much you might want them to.

You will not receive the FDA’s stamp of approval until you meet all of their guidelines and show documentation to prove your compliance with all FDA regulations.

So what can you do to get over the FDA’s hurdles as quickly as possible?

How to Trim Back the FDA Medical Device Approval Timeline

In most cases, it will take at least 177 days (or about six months) for the FDA to clear medical devices from application submission to approval. However, some devices will take much longer — anesthesiology, hematology, and immunology devices might take nine months or more!

One of the most significant delays in the FDA approval process is gathering and presenting documents — the right documents, in the right way, at the right time.

If you have a robust enterprise Quality Management System (eQMS) in place, you would know ahead of time what documents are needed and could simply follow the plan. You might still get questions from the FDA (because that’s just how they operate), but answering those questions wouldn’t mean having to generate entirely new data — most of the time.

Helping you develop life-changing devices and get them to market safer and faster is what we built the Qualio eQMS to do. The right tools and support can help you generate revenue sooner by helping to scale back the “therapeutic claims” for your first clearance hurdle, and then you can expand your indications/claims for your phase 4 type studies.

Start with 510(k), Then PMA

What is 510(k) approval?

510(k) clearance is all about proving that your device is “substantially equivalent” to an existing device that was cleared by the FDA or that was marketed before 1976. 510(k) submissions are generally accepted faster for several reasons.

  1. You are comparing and contrasting your device with a previously approved device and explaining why any differences should be acceptable.
  2. Human data is generally not required, but this decision is made at the FDA’s discretion.
  3. The law gives the FDA either 30 or 90 days to clear the device, ask questions, and reject the application based on the type of device in question.

What Is Premarket Approval (PMA)?

PMA submissions are used when your device type is new or modified, and you need to demonstrate to the FDA that it is safe and effective for the intended usage. PMA requires a higher standard than 510(k) and therefore takes longer to receive.

  1. You will almost always be required to conduct a formal clinical study to gather human use data in addition to your lab studies.
  2. The FDA has up to 180 days to approve, question, or reject your application.

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The Fastest Path to Approval

If your device classification can start with a 510(k) approval, that can allow you to get to market faster. Then, after you get some revenue flowing, you can expand your product and marketing and seek PMA.

Related Reading: 4 Reasons Overhauling FDA 510(k) is a Great Move

Skip the Shortcuts

You already know how important it is to get to market quickly, so it’s no surprise that you’d be tempted to skip some of the checkboxes on your application to the FDA.

Checking those boxes can mean running extra tests, building more reports, and collecting even more data. It’s time-consuming and exhausting. It may seem easier to try to explain to the FDA why those boxes don’t need to be checked.

In our experience, we’ve never seen these types of shortcuts work.

You may find ways to get creative with how you check off those boxes, but they still have to be checked.

It’s futile to argue with the FDA, and trying can seriously damage your relationship with your FDA officials — which can cause you unnecessary delays and put you through more hurdles before you can reach approval.

Related Reading: FDA Audit: Medical Device Companies Should Watch Out for These 7 Mistakes

Hire a Consultant

The amount of red tape that you have to get through before getting to market can be significant and intimidating. Hiring a consultant can help you get through everything much faster and easier.

You don’t have to learn everything alone. You can lean on the consultant’s expertise and proven processes to get through the FDA approval process much faster than you would be able to alone.

A skilled FDA consultant can help prepare you in advance with everything the FDA will request before granting approval.

Related Reading: Who’s the Best FDA Consultant for Medical Device Manufacturers? (Reviews)

Pick a Great Enterprise Quality Management System (eQMS)

Receiving FDA approval is a process that requires stringent proof that you’ve followed all the guidelines and checked all the boxes.

Documenting your activities and providing a paper trail doesn’t have to involve a literal trail of physical paper anymore. You can avoid delays in getting your device to market, improve quality, reduce errors, and improve operational efficiency with the right eQMS software.

Qualio is built for small to mid-market organizations that have aggressive growth goals and want an affordable solution. Qualio is the only eQMS designed specifically for startups, scale-ups, and SMBs in the life sciences industry. Our software is designed per FDA cGMP, and ISO requirements for pharma, biologics, and medical device manufacturers.

Schedule a custom demo today and find out how we can help you get your device to market faster. This call won’t be a generic 20-minute sales pitch. We’ll talk about your company, your needs, and your device and show you which specific features will help you reach your goals.

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Published by Robert Fenton November 7, 2019
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