Partnering with Nemera for the management of the whole combination product.

The FDA has at last published the Draft Guidance on “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products”.

Access to the document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/essential-drug-delivery-outputs-devices-intended-deliver-drugs-and-biological-products

This crucial guidance provides a structure for the industry to comprehend how EDDOs ought to be integrated into the development of combination products.

We at Nemera clearly see the value of this guidance in enhancing the safety, efficacy, usability and reliability of drug delivery devices. It helps us ensure that Nemera’s, customers’ and partner’s products meet high standards through rigorous identification, control, and maintenance of EDDOs. This guidance supports our mission to innovate in drug delivery solutions while maintaining quality and regulatory compliance.

Value of the Guidance

This guidance is helpful for manufacturers of drug delivery devices and combination products. It provides recommendations on identifying, controlling, and maintaining EDDOs, ensuring these devices perform their intended functions reliably. By following this guidance, manufacturers can improve product quality, enhance regulatory compliance, and streamline development processes, ultimately leading to usable, safer, and more effective drug delivery solutions.

However, there are areas where additional clarification from the FDA could enhance the utility and implementation of this guidance. Specific comments and suggestions will be shared with the FDA to ensure comprehensive understanding and address any potential ambiguities (Terminology, application on other drug delivery devices, comparing EDDOs to Primary Functions as in the ISO 11608, control strategy, V&V requirements, traceability, interaction with FDA…).

Partner with us to manage the whole of your combination product

We offer a comprehensive suite of device development and combination product consulting services to ensure the success of your drug-device development journey. Our combination product services include human factors management (including Design Validation), instructional/packaging materials, as well as quality, design control, regulatory and compliance strategy, and submission authoring for combination products. Our services align with the stringent requirements set out by FDA, Europe and ISO standards.

Our quality and regulatory team can help manage numerous activities that are related to this new guidance:

1. 🔍 EDDOs: We can support in identifying, controlling, and maintaining Essential Drug Delivery Outputs (EDDOs) to ensure your combination product performs as intended.
2. 🔧 Robust Design Control: Our comprehensive design control procedures align with FDA regulations and ISO standards, ensuring your product meets all necessary requirements.
3. 🧪 Rigorous Verification and Validation: We conduct thorough verification and validation testing to simulate real-world conditions, guaranteeing device reliability.
4. ⚙️ Risk-Based Control Strategies: Our tailored control strategies mitigate risks and ensure consistent product performance.
5. 📜 Regulatory Compliance: Stay ahead of regulatory requirements with our up-to-date regulatory surveillance, knowledge, and proactive communication with the FDA.

By partnering with Insight, you gain access to our state-of-the-art facilities and a team of dedicated experts committed to providing tailored solutions for your unique needs. Explore our integrated services to learn how we can accelerate your speed to market.

Connect with us on LinkedIn or visit our website to learn more about how we can support your combination product journey.

We're here: Insight by Nemera - Nemera