FDA Suspends Premarket Notification Requirement For 7 Devices; 84 More Under Consideration

Source : Medtech Insight

The US Food and Drug Administration will no longer require premarket notifications for seven low-risk medical devices, and may stop requiring them for 83 more moderate-risk devices and an unclassified device.

The agency issued emergency guidance documents during the COVID-19 pandemic that temporarily suspended premarket notifications for a slew of class I low-risk products including clinical electronic thermometers, and personal protective equipment like surgical gloves and face masks. ()

In a 14 January notice, the FDA and the Department of Health and Human Services (HHS) said that based on their experience over the past year, they are suspending premarket notification requirements for seven devices immediately, which could save significant time and resources and possess no significant increased risk.

The seven devices are various types of gloves, including:

Powder-free polychloroprene patient examination gloves;

Specialty patient examination gloves;

Radiation attenuating medical gloves;

Powder-free non-natural rubber latex surgeon’s gloves;

Powder-free guayle rubber examination gloves;

Latex patient examination gloves; and

Vinyl patient examination gloves.

Regulators are also considering waiving premarket notifications for an additional 83 class II devices and one unclassified device after stakeholders have a chance to give their input on the decision during a 60 day comment period.

Regulators estimate that the cost of preparing premarket notifications for the seven devices alone to be between $100,000 and $4m. If all 91 devices under consideration are waived, the FDA estimates it would save industry between $9.1m to $364m in start-up costs if there were one new entrant into each device market.

“Instead of being costs passed along to patients and taxpayers, these savings could be invested in other areas such as research and development and manufacturing,” regulators said. “At the same time, should these waivers go into effect as proposed, patients stand to gain more immediate access to new products that would otherwise be required to obtain a 510(k) clearance prior to marketing.”

The FDA argues the exemptions would also save the agency review resources.

“The COVID-19 [public health emergency] stretched FDA’s review capacity,” the agency said. “Under this notice, FDA’s review resources can be redeployed to review other innovative technology, to include devices designed to mitigate the impact of COVID-19.”

Under the Federal Food, Drug, and Cosmetic Act, the HHS secretary is authorized to waive premarket notification requirements for class I and class II products in order to shift the FDA’s resources to review riskier devices. Further, under the 21st Century Cures Act lawmakers directed the secretary to review all class I and class II products to determine if requiring premarket notifications for such products makes sense. Finally, in May 2020, President Trump issued Executive Order No. 13924 that required the heads of all agencies to review regulations that were temporarily suspended to determine if suspending them permanently would help with economic recovery after the coronavirus pandemic is over.

With all that under consideration, regulators reviewed adverse events in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database and concluded that waiving premarket notifications for the seven class I devices and additional 84 devices under consideration would save money and resources. They do, however, acknowledge that evaluating the true potential of public risk posed by those devices based on information in the MAUDE database has its limitations because adverse events are self-reported by device manufacturers and the data is not always timely, accurate, complete or unbiased.

The HHS says its review warrants further study and expansion into other class I and class II devices to determine if there are more devices that can benefit from a premarket notification waiver. The department notes that FDA’s medical device product code data includes 6,651 unique codes, of which 157 are for class I devices and 2,662 are for class II devices that require 510(k) clearance. By eliminating premarket notification requirements for these products, industry could save between $282m to more than $11bn in start-up costs, even if only one new product enters the market for each of the 2,819 product types.

“Further, again assuming a 90-day review period and one new device entrant in each of the 2,819 device classes that require 510(k) notification, FDA’s current approach creates 253,710 review days, or 695.1 review years between Americans and new devices,” regulators said. “The question of whether the 510(k) notice is justified in view of safety and efficacy concerns merits comprehensive analysis for the benefit of Americans.”

By Ferdous Al-Faruque