More than 200 types of medical devices and testing products are newly exempt from safety and effectiveness reviews according to a Food and Drug Administration (FDA) policy that went into effect Dec. 30.
FDA’s end-of-year order lessens the burden of premarket review and associated costs for medical device and test manufacturers, as reported by MedTech Dive.
The sweeping exemption covers a range of common devices used in major medical specialties, including cardiology, gynecology, urology, gastroenterology, ophthalmology, radiology, plastic surgery and neurology. Examples of newly exempt devices, which the FDA has identified as low risk according to MedTech Dive, include components of a shunt used in brain surgery and a colposcope, a viewing device for detecting early signs of cervical cancer.
Only Class I or Class II devices, which the FDA considers less risky than Class III devices, are included. FDA approval for Class I and Class II devices involves the agency’s less stringent 510(k) “premarket notification” or “premarket submission” process. This process requires medical device manufacturers to give the FDA 90 days’ notice of their plans to begin marketing a new or modified medical device. Under 510(k), device manufacturers can obtain FDA approval by showing that their new or modified device is “substantially similar” to another already approved device. This stands in contrast to the Class III device approval process, which requires new clinical research on each proposed device.
But the FDA has now exempted dozens and dozens of tests and devices from the 510(k) review process under the new rule.
Why Did the FDA Exempt So Many Medical Devices?
The FDA explained the rationale behind the new rash of exemptions in the body of the rule:
“FDA’s determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.”
But patient advocates, who already fear that the 510(k) process is too lax, suggest the FDA may be shirking its medical device safety watchdog responsibilities.
“The bottom line is that the FDA has decided that there are many more devices that can be sold without any scrutiny at all,” Diana Zuckerman, president of the National Center for Health Research, told MedTruth in an email.
Under the 510(k) process, a new medical device could potentially be approved for market even if the comparative review was based on a device that was eventually recalled or found to be defective.
To compound this issue by exempting scores of devices from any regulatory scrutiny is, according to Zuckerman, “dangerous for patients, and puts doctors and patients in a situation where they should be afraid to try any new devices that have been exempted from even the most basic FDA standards.”
“And it is unfair to device companies whose leadership takes pride in their higher standards,” she said.
Exemptions Tied to Controversial 2016 Law
The FDA pinned the broad exemptions on the 21st Century Cures Act, a 2016 law that put new procedures in place designed to accelerate medical product development and deliver potentially life-saving cures to patients more quickly.
Zuckerman, however, told MedTruth that the Cures Act didn’t require the FDA to make “so many exemptions, but the act has encouraged the FDA to lower its scientific standards for devices and drugs.”
“Many members of Congress who voted for the bill did not realize how devastating the impact would be on patients, physicians, and on FDA’s reputation as a ‘gold standard’ for safety,” she told MedTruth.
However, good news may be on the horizon. Zuckerman believes the recent appointment of Dr. Stephen M. Hahn as FDA commissioner might reverse this trend.
Keywords
• Medical Devices
Nicole Knight
Nicole Knight is a freelance writer based in Southern California. A former reporter for the Orange County Register, she most recently covered issues related to women’s health and economic justice for the nonprofit site Rewire.News. Her bylines have appeared in outlets ranging from Pacific Standard to Parents.com, reflecting her varied interests. She is a member of the Association of Health Care Journalists and the American Society of Journalists and Authors. Follow her on Twitter @nicolekshine.
How long does FDA medical device approval process take?
How long before your medical device startup runs out of money? That depends on how long it takes before you start generating revenue. And generating revenue won’t happen until you get approved by the FDA, which can take some time.
Innovation and time-to-market are the top two competitive drivers for the medical device industry, according to researchers. Mark Perkins of Novozymes excels in a highly competitive marketplace by engineering speed into the entire product life cycle. “[We’ve] worked to ensure there is an established pathway through the regulatory approval process.” Perkins’s life sciences company focuses on compliance from day #1 to avoid last-minute snags with agency approval.
You shouldn’t begin preparing for FDA medical device approval process too late in the game. The most successful device manufacturers approach the process with a realistic understanding of the resources required, including time and money. With an understanding of the FDA pathways, you can better manage finances until you start generating revenue. We’ll show you how long to expect this process to take.
The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process. Studies reveal it takes three to seven years in total from concept to approval, compared to an average of 12 years for drugs. However, this figure is an inclusive measure of the entire device lifecycle, including research & development and testing.
It’s never too early to begin preparing for an FDA submission. The most effective way to predict speed-to-market is to evaluate the level of risk associated with your medical device and determine if it is a Class 1, 2, or 3 device. There are three possible pathways to market approval:
• Self-registration
• 510(k) submissions
• Premarket Approval
To understand device classification, we recommend:
What are the Differences in the FDA Medical Device Categories?
Most Class 1 devices are exempt from the 510(k) clearance pathway, per the agency. The majority of devices that are already approved for sale fall under Class 1 and present the lowest risk to patients. Class 1 devices include non-invasive items such as tongue depressors, oxygen masks, and electric toothbrushes.
Learn more in Does an FDA Class 1 Medical Device List Exist?
While a small percentage of Class 1 devices require a 510(k) submission, the majority can be self-registered with the agency. This is a three-step process, explained in-depth on the FDA website.
- Pay the registration fee.
- Electronically submit listing and registration info.
- Receive an email of acceptance from the FDA.
- These steps cannot be completed simultaneously. Generally, it takes “several days” for a Device User Facility Registration fee to be accepted by the agency before you can electronically submit your registration. The agency’s FAQ does not address the average length of time between electronic registration submission and acceptance.
- While the self-registration process for Class 1 devices isn’t instantaneous, it’s by far the fastest path to market and shouldn’t involve any long wait times. You may be able to complete device registration in one week.
Class 2 Devices
43% of medical device applications fall under Class 2. This moderate-risk category includes devices such as contact lenses, syringes, and catheters. According to the agency, the majority of Class 2 medical devices require a 510(k) application, in which the manufacturer demonstrates a device’s safety and efficacy through substantial equivalence to another currently approved device.
The FDA is required to respond to complete 510(k) submissions within 60 days of receipt. However, this response isn’t a clearance; it’s simply a notice that your application is complete and accepted for review.
The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months.
The average number of days it takes to clear a device via 510(k) varies according to the device category. Anesthesiology devices have the longest average length to approval, averaging 245 days. Toxicology devices are the shortest on-average, at just 163 days.
Please note that an overhaul of the 510(k) pathway is on the immediate horizon. It is unclear at this time whether these changes will impact the approval timeline. Learn more in 4 Reasons Overhauling FDA 510(k) is a Great Move.
The FDA medical device approval process is just one component of bringing a device to market. The length of time to approval for your device is likely to vary depending on whether you select the traditional or abbreviated 510(k) pathway, and according to your device class. However, if your Class 2 device qualifies for 510(k), it’s wise to anticipate approximately a six-month wait from the time your device application is submitted.
RELATED READING: The Difference Between Premarket Notification 510(k) and Premarket Approval
Class 3 Devices
Class 3 medical devices are the most innovative and invasive devices, which potentially present the highest risks to patient health and safety. This class constitutes approximately 10% of devices and includes devices like cochlear implants, defibrillators, and implanted prostheses.
The majority of Class 3 devices follow the PMA pathway. PMA is the agency’s process of scientific and regulatory review and the most stringent type of application possible. The PMA pathway involves presenting adequate scientific evidence to demonstrate safety and efficacy.
While preparing a PMA application is generally significantly more intensive than a 510(k) app or self-registration, it’s surprisingly not much longer of a wait post-submission. According to a report from the agency, the average PMA application is approved 243 days post-submission. That’s just over eight months, or 66 days longer than the average time to approval for a 510(k) application.
Class 3 medical devices are being approved faster than ever before. The agency has worked in recent years to improve the PMA pathway and reduce the wait time while maintaining a focus on patient safety. Prior to 2010, the average wait for a PMA approval was 345 days or nearly 12 months. That’s a speed-to-market increase of 111 days, on average, in the past nine years. Currently, 92% of PMA applications are approved by the agency.
How to Shorten the FDA Medical Device Approval Process
Device class and approval pathway have a huge impact on the average length to wait for the FDA medical device approval process to complete. But is there anything you can control to speed up time-to-market? Your average wait can depend on how well you write your submission for any Class of device, and how well you “tick all the boxes” for your product by demonstrating substantial equivalence or proving safety and efficacy.
Remember, the FDA is collaborative if you let them be a partner. They want to bring innovative, safe devices to market quickly, and they’ve made themselves more accessible to speed up approvals. If you take the old school approach of doing the bare minimum based on your assumptions, you’ll get stuck. As soon as you break the FDA’s trust in your intentions, they’ll throw the book at you. Be open, collaborative, and take advantage of their newer “interactive” review approach.
It’s never too early to begin preparing for successful submission. This starts with a comprehensive quality management system and effective document management practices. This groundwork is essential to quickly create an effective application for any FDA approval pathway.
You can’t completely control the FDA’s response time to your application, but you can engineer speed and quality into your entire organization with Qualio, a cloud Enterprise Quality Management System (eQMS) built specifically for startup and scale-up medical device manufacturers.
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