The global COVID-19 pandemic, and the subsequent public health emergency it created, changed much about our everyday lives, and the medical device industry is no exception. To respond quickly to the health need and provide the American public with expanded access to certain medical devices, the U.S. Food and Drug Administration (FDA), the government body that regulates medical devices, issued guidance allowing regulatory flexibilities, including a temporary waiver of premarket notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act, otherwise known as 510(k) clearances. This swift action has led many to wonder what it means for the future of the impacted 510(k) devices and beyond.
What is a 510(k) Clearance?
A medical device undergoing FDA approval goes down one of two paths – 510(k) certification or pre-market approval (PMA). The FDA’s 510(k) certification is the simpler process of the two. A new device improving on an existing device or process will probably follow the 510(k) approval process, where the evaluation is based on similarities between the submitted device and a previously approved device.
When is a 510(k) Clearance Required?
Unless there is an exemption, any company that wants to sell a medical device in the United States after May 28, 1976, is required to submit for a 510(k) FDA approval at least 90 days before attempting to sell the device. This includes:
- Domestic manufacturers introducing a device to the U.S. market
- Finished device manufacturers if they manufacture a device according to their own specifications and market it in the U.S. This includes accessories to finished devices that are sold to the end user as they are also considered finished devices, but not does include device components unless they are promoted for sale to an end user as replacement parts.
- Specification developers introducing a device to the U.S. market
- Repackers or relabelers who make labeling changes or whose operations significantly affect the device
- Foreign manufacturers or exporters or U.S. representatives of foreign manufacturers or exporters introducing a device to the U.S. market
Some Class I (low risk) and Class II (medium risk) devices are exempt from the FDA 510(k) approval process. If there is a change or modification to a device that has already received a 510(k) clearance, the burden is on the 510(k) holder to decide if the modification could significantly affect safety or effectiveness of the device.
How Long Does a 510(k) Clearance Take?
The FDA’s 510(k) review timeframe is 90 days, which stops if the regulators issue a Refuse-to-Accept (RTA) or Additional Information (AI) letter because they need more information or documentation to complete their review. Any RTA and AI responses must be submitted within 180 days.
How has COVID-19 Impacted 510(k) Clearances?
In conjunction with the regulatory flexibilities and temporary waiver of some 510(k) FDA approval requirements during the COVID-19 public health emergency, the U.S. Department of Health and Human Services (DHHS) has permanently exempted seven Class I devices from the 510(k) clearance requirement. This is not the first time FDA regulatory oversight has expedited changes to its process to accommodate rapid industry transition and public need, but it has raised additional questions on the long-term status of the devices subject to COVID related flexibilities and waivers. The DDHS is proposing an exemption for an additional 83 Class II devices and one unclassified device class from the 510(k) requirement where premarket review has been waived during the pandemic. The Department is currently soliciting public comment on the issue.
Regardless of what the DHHS ultimately decides, Sterling has FDA medical device regulatory compliance consultants who can help you achieve regulatory, quality, and clinical compliance with country-specific requirements. With intelligence on the most up-to-date requirements with 510(k) clearances and more, our experts will lead all clinical and regulatory program management activities, so you don’t have to. Contact us today.
