Emergo conducted a review of public data on medical devices cleared by the US Food and Drug Administration between January 1, 2010 and December 31, 2014.
The 15,000+ device clearances examined went through the FDA’s Premarket Notification program, more commonly known as the 510(k). This process applies to nearly all Class 2 devices, and a relatively small percentage of Class 1 and 3 devices.
For purposes of analysis we separated the devices into four basic categories:
- Traditional 510(k) submissions reviewed by internal FDA staff (72% of all)
- Traditional 510(k) submissions reviewed by Third Party Reviewers authorized by the FDA (6% of all)
- Special 510(k) submissions (20% of all)
- Abbreviated 510(k) submissions (5% of all)
Want to know the historical average review time for your device? Be sure to try our new FDA 510(k) calculator, which shows the average review time for specific devices cleared by FDA between 2010 and 2014. Try the new FDA 510(k) review times calculator now.
Key takeaways from this year’s analysis:
- A company submitting a 510(k) today has a 22% chance of getting it cleared within 3 months, and a 61% chance of getting it cleared within 6 months.
- There were 3,173 devices cleared through the 510(k) program in 2014, a 4.5% increase over 2013 but similar to numbers seen in 2011 and 2012.
- Radiological and Orthopedic devices tend to take the least amount of time to clear, averaging 135 and 140 days respectively in 2014.
- Third Party Reviewers clear devices in 68 days on average, more than 110 days faster than internal FDA reviewers. Caveat: Complex devices do not qualify for this program.
- Over the last 15 years, the FDA has been taking progressively longer to clear 510(k) submissions, which now averages about 6 months.
NOTE: The FDA does not release data on how many 510(k) submissions are rejected outright, withdrawn or abandoned by the submitter. This analysis only includes devices cleared by the FDA and does not include devices subject to the Pre Market Approval (PMA) process.
510(k) review times have been growing...
22% of devices are cleared within 3 months...
More devices were cleared in 2014 compared to 2013...
Review times for some major categories of devices...
Third Party Review may speed the process...at a cost
NOTE: 20% of devices are cleared via Special 510(k) submissions. According to the FDA: “A Special 510(k) may be submitted for a modification to a device that has been cleared under the 510(k) process. If a new 510(k) is needed for the modification and if the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design control process can serve as the basis for clearing the application.”
Abbreviated 510(k) submission times remain steady...
NOTE: Only 5% of devices are cleared via Abbreviated 510(k) submissions. According to the FDA: “Device manufacturers may choose to submit an Abbreviated 510(k) when a guidance document exists, a special control has been established, or the FDA has recognized a relevant consensus standard. An Abbreviated 510(k) submission must include the required elements identified in a Traditional 510(k). However, in an Abbreviated 510(k) submission, firms elect to provide summary reports on the use of guidance documents and/or special controls or declarations of conformity to FDA recognized standards to expedite the review of a submission.”
- The FDA has cleared more than 140,000 devices via the 510(k) program since its inception in 1976
- Back when the 510(k) program started, the average time to get a device cleared was just 38 days.
- The longest time ever to get 510(k) clearance was for three submissions filed by the same company at the same time in late 1998. Those devices cleared in early 2007 – a whopping 3,037 days (8.3 years) later!
All 510(k) submissions are assigned a “K number” – the letter K followed by six digits. The first two digits of the 510(k) number indicate the year it was submitted to FDA for review. The next four digits are sequential starting at 0 and indicate the order in which the submission was received during the year. The first 510(k) ever was submitted by Zimmer Inc. which holds K760001, submitted on May 26, 1976. Boston Scientific Scimed Inc. is the proud owner of K000001. No, it's not the first 510(k) ever, but it was the first one submitted in the new millennium on January 3, 2000! Many others were submitted that same day but their submission made it to the top of the pile!