EMERGO SUMMARY OF KEY POINTS:

• The FDA has expanded requirements for validation data in 510(K) applications to several types of reusable devices.
• Validation data requirements go into effect for these devices starting August 8, 2017.
• Eleven device types comprising 40 product codes have been identified for validation data requirements.

Medical device market regulators at the Food and Drug Administration have issued a new list of reusable medical devices for which validated Instructions for Use as well as validation data for cleaning and sterilization will be required for 510(k) submissions.

The new list and requirements are part of the FDA’s ongoing efforts to comply with the 21^st Century Cures Act of 2016. The agency published guidance on required validation methods for reusable devices in 2015; that guidance now also applies to the new list of reusables.

Reusable medical devices included in the new list

The FDA’s new list includes 11 device types and associated product codes for which instructions for use and validation data are now necessary in order to determine Substantial Equivalence:

• Bronchoscopes and accessories: 12 product codes
• ENT endoscopes and accessories: six product codes
• Gastroenterology and urology endoscopes: three product codes
• Automated reprocessors for reusable devices: five product codes
• Other endoscopes: two product codes
• Neurological endoscopes: one product code
• Water-based cooler systems for operating rooms: two product codes
• Computer-controlled instrument surgical systems: one product code
• Arthroscopes: one product code
• Laparoscopic instruments: one product code
• Electrosurgical instruments: one product code

US regulators view these devices as posing high risk of infection as well as inadequate performance in patients without stronger requirements for reprocessing. Expanding its 2015 reprocessing guidance to include the devices listed above will help mitigate these risks, states the FDA.

FDA 510(k) applicants whose reusable devices are identified in the new list must begin providing validation data in their submissions starting August 8, 2017.

Additional US medical device regulatory resources:

• US FDA 510(k) premarket notification consulting
• Medical device design, process and software validation support
• Whitepaper: FDA 510(k) submission preparation
• Video overview: The US FDA medical device registration process