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How Long Does it Take the FDA to Approve a Medical Device?

Author: Carrie Britton | Date: September 1, 2021

Months and dates shown on a calendar whilst turning the pages

According to research, time-to-market is a primary competitive driver in the medical device industry, second only to innovation.* You can’t start making money until you get FDA approval for your medical device.

So, how long does it really take for the FDA to approve a medical device? The short answer: anywhere from one week to eight months, depending on the device class and a range of other factors.  

To give you a better sense of how long it takes for the FDA to approve a medical device, let’s delve into the basics about the FDA’s medical device approval process as it pertains to each of the three classes:

  • Class I medical devices have a low impact on patients’ overall health and are subject to the fewest regulatory requirements
  • Class II devices are moderate-risk devices that require a Premarket Notification 510(k)
  • Class III devices follow rigorous controls, most of which require a Premarket Approval (PMA)

The majority of Class I devices can be registered and listed with the FDA, which offers the fastest path to approval—as short as a week or two. Class II is a bit more complicated. First, you’ll need to submit a 510(k) application demonstrating that your device is Substantially Equivalent (SE) to one or more predicate devices previously cleared by the FDA. Once the submission is received, the CDRH or CBER’s Document Control Center (DCC) will assign the unique submission control number. If the proper user fee has been paid and a valid eCopy has been provided, the DCC will then email an Acknowledgement Letter that notes the date they received the submission and the number assigned to it. The submission is then assigned to a Lead Reviewer, who will conduct the Acceptance Review, and if it meets the minimum threshold of acceptability, they will then respond according to the Refuse to Accept (RTA) Policy, within 15 days.

At the end of the 15 days, you will receive the Acceptance Review results, which will include the name and contact information of the Lead Reviewer assigned to the 510(k) and the status of the 510(k), which will be one of the following:

  • The 510(k) was accepted for substantive review; or
  • The 510(k) was not accepted for review (i.e., considered refused to accept or RTA); or
  • The 510(k) is under substantive review because the FDA did not complete the acceptance review within 15 calendar days.

The status that’s assigned will directly impact how long it takes for the FDA to approve your medical device. If the FDA refuses the submission, the application will be put on RTA Hold for up to 180 days. At this point, you’ll have 180 days to fully address the deficiencies cited in the RTA Hold. If it is not done, the 510(k) is considered withdrawn and deleted from the system. If it is deleted, a new 510(k) must be submitted to obtain market clearance.

Substantial Review Process:

When considering how long it will take for the FDA to review your medical device, don’t forget to factor in the substantial review process, which begins as soon as the submission is accepted. At this time, the FDA may reach out to you with an Interactive Review to address “easy to fix” items or obtain information that may be adequately addressed within the timeframe set by the Medical Device User Fee Amendment  (MDUFA) performance goal for 510(k) (90 FDA days). If the Lead Reviewer sends an AI Request, the submission will be placed on hold, at which point you have 180 days to submit a complete response to the AI Request.

More about the Substantive Review Process:

To get a better idea of how long it will take the FDA to approve your medical device, keep the following in mind: First, any correspondence with the FDA during the Substantive Review process should be reviewed in a timely manner. Second, even if you do provide additional information as requested, don’t assume the FDA won’t issue a formal Additional Information (AI) request.

Be sure to submit all requested information as soon as possible; the FDA will not review it until it is received in its entirety, which will only add to the time it takes for the FDA to approve your medical device. After the AI Request is submitted, they will issue an SE or NSE letter for the submission. As noted earlier, the CDC must receive your response within 180 calendar days of the date of the AI Request or the submission will be withdrawn and deleted. No extensions beyond 180 days will be granted. To minimize the time it takes for the FDA to approve your medical device, it is imperative that you avoid going beyond this critical 180-day mark.

When a decision is made, the FDA will issue the decision letter to the submitter by email to the email address provided in the 510(k) cover letter. A 510(k) that receives an SE decision is considered “cleared.” The FDA will then add the cleared 510(k) to the 510(k) database, which is updated weekly. The IFU and the summary will be sent as attachments to the SE letter. The IFU will not be signed since it is considered an attachment to the SE letter. Therefore, the signature on the SE letter will apply to both the letter and the IFU.

There may be some interaction with the FDA after the AI submission to finalize any remaining items. In most cases, the FDA expects a same-day or next-day response to their inquiry to meet the 90-day target for 510(k) review.

510(k) Decision Letter:

In order to minimize the time it takes for the FDA to approve a medical device, their goal is to make a MDUFA Decision for a 510(k) within 90 FDA Days (the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI Request). MDUFA Decisions for 510(k) submissions include findings of substantially equivalent (SE) or not substantially equivalent (NSE).

So, how long does it take for the FDA to approve a Class II medical device? A good guidepost is six months, though some may get approval in as short as three.

Graphical explanation of the 510(k) process:

Class III devices generally follow the PMA pathway. The most involved of the FDA’s medical device approval pathways, this pathway requires scientific evidence to demonstrate safety and efficacy. While this process is more intensive than a self-registration and a 510(k), the FDA’s timeline for a Class III medical device approval is shortening, averaging eight months.

How to Reduce the Time it Takes for the FDA to Approve a Medical Device

You can’t control the FDA’s medical device approval timeline, but there are some things you can do to streamline the process:

  • Prepare early: Before you do anything else, be sure you have a solid understanding of the FDA’s role in your medical device development process. Identify which FDA medical device approval pathway applies to your device so you can allocate the appropriate time, money and resources required.  
  • Partner with the FDA: Don’t view the FDA as a roadblock, but rather as a partner who is ready and willing to collaborate to get your product to market faster. While their job is to ensure safety and efficacy, they also want to get innovative products out to patients expeditiously. Form an open, collaborative relationship early—and don’t cut corners. When you establish trust, they’ll be more likely to work with you to speed up approvals.
  • Write a comprehensive submission: Regardless of your device class, do your due diligence in demonstrating SE or proving safety and efficacy. Take your time writing the submission and be sure you’ve got all the proverbial boxes checked.
  • Get help with your prototype: Partner with a medical device prototype development expert who will ensure adherence to standards, provide proof that all risk factors were considered and guarantee a reliable and safe medical device.

You can’t predict precisely how long it will take for the FDA to approve a medical device. But by having a basic idea of the FDA’s medical device approval pathways and timelines, you can better plan, take proactive steps and ensure a smoother process. At Sterling Medical Devices, our medical device regulatory compliance consultants can help you navigate the complex FDA approval process and ensure your device meets the required regulatory controls.

For more detailed information about how long it takes for the FDA to approve a medical device or anything else related to getting your device approved, contact Sterling Medical Devices here.


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