May 3, 2018

EMERGO SUMMARY OF KEY POINTS:

  • New guidance explains FDA approach to multiple-function products that feature device and non-device components.
  • FDA may assess non-device components of a multi-function product to determine their impact on the safety and effectiveness of the product’s features that do meet the definition of a medical device.

US FDA medical device oversight of multiple function products 2018New guidance from the US Food and Drug Administration addresses premarket authorization requirements for multiple-function products with at least one function that qualifies as a medical device.

In the new draft guidance, FDA defines products with at least one device function as multiple function device products, and explains the agency’s approach to determining such a product’s non-device functions on the safety and effectiveness of that product’s device function—even though non-device functions are not subject to premarket review.

Defining the FDA regulatory scope of non-medical device functions

Multiple function device products may include various functions falling in or out of FDA’s regulatory purview for medical devices.

FDA argues in the guidance that the agency’s authorization by the US Food, Drug & Cosmetic Act to regulate products featuring at least one device function and one non-device software function also applies to assessment of all multiple function products that contain at least one device function, including combination products.

The new guidance incorporates safety-focused risk management recommendations based on the ISO 14971 standard, according to FDA.

FDA premarket review requirements for multiple function products

Although FDA states that it does not evaluate software and other functions of a multiple function product that do not meet the definition of a medical device, the regulator may assess the impact of  non-device functions during premarket reviews on products’ overall safety and effectiveness.

The guidance lays out pre- and post-market FDA approaches to device- and non-device components of multiple function products:

Function:

Premarket requirements:

Postmarket requirements:

Device function

Reviewed via 510(k), PMA, IDE, De Novo or HDE routes

General control requirements

510(k)-exempt device function

No review, but assessed for impact on safety and effectiveness

General control requirements

Device function not requiring premarket review

Assessed for impact on safety and effectiveness

General control requirements applicable but not enforced

Non-device function

Assessed for impact on safety and effectiveness

No FDA postmarket requirements applicable

Source: US FDA

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