FDA Suggests Alternatives for Complying With QS Requirements

June 22, 2018

The FDA put out a list of alternative ways to comply with quality system requirements for device combination products, making suggestions for design controls and quality system regulation exemptions.

Combination product manufacturers can use existing pharmaceutical development practices and documentation that align with the 21st Century Cures Act’s requirements and design control principles for meeting device QS regulations, the agency said.

The combination product can also be exempted from certain — and in some cases all — device QS requirements if the device constituent that is part of the combination product is exempt from such requirements and use of the part is within the scope of the exemption.

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