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510(k)s Make the Medical Device World Go Round

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Authors: Haley Lentz, Sales Manager & Rachel Benway, Product Manager, Reed Tech

The medical device industry is constantly innovating new ways to treat patients in settings ranging from acute surgical care, to outpatient health centers and to home use. Of course, with such a wide range of device types and treatment offerings device manufacturers have varying methods of receiving FDA approval.
FDA premarket approval submission methods vary based on the class of device, potential safety risk posed to the patient and novel nature of the device design. The most widely used of all premarket approval submission methods is the 510(k) Clearance Pathway.

510(k) submissions make up an average of 53% of all medical device premarket submissions per year over the last 10 years. In fact, since January 1, 2020, 400 medical devices have been cleared through the 510(k) submission pathway – that is over seven new devices cleared to enter the market each day!

In order to get clearance for a new device via the 510(k) pathway, the applicant must demonstrate that the device is substantially equivalent to a predicate – a device already on the market and cleared by FDA. The most effective way to claim substantial equivalence is to find a device with the same intended use or indications for use as the proposed device. If a predicate can be found, use of the 510(k) pathway can save both time and money.

This process of finding and listing predicate devices makes it possible to track successors or new products that are substantially equivalent to existing products resulting in a web or family of similar devices. Many companies use their own 510(k)s as predicates for their newer devices. More commonly, the device is used as a predicate by a different company. Device manufacturers who track successors can use this information to identify potential competitors or to find new entrants to the market. The products most commonly used as predicates are shown in the table below. This table also shows the percentage of the predicate’s successor devices that are manufactured by a different company. Not surprisingly, this list includes some of the largest medical device companies including Medtronic and Johnson & Johnson.

Life Sciences organizations can utilize this information for a number of strategic purposes, including competitive intelligence, merger and acquisition due diligence and research and development. Reed Tech can facilitate a simpler analysis of this valuable data with Navigator for Medical Devices. Navigator consolidates data from over a dozen disparate locations and can support your organization’s decision-making by connecting regulatory data with safety and quality information to provide a well-rounded view of device portfolios.

To find out which companies are using your products as their predicate, or learn more about Navigator for Medical Devices, reach out to our team at 267.961.0232 or emcdermott@reedtech.com.

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