By Fran DeGrazio, executive editor
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The recent FDA draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products was one of the most highly awaited documents for biopharma professionals involved in developing and bringing drug- or biologic-led combination products to market. Frankly, the first thing that jumps out of the document, especially to those, like me, with significant history within the industry, is the change in terminology from Essential Performance Requirements (EPRs) to Essential Drug Delivery Outputs (EDDOs). The FDA guidance defines EDDOs as “design outputs necessary to ensure delivery of the intended drug dose to the intended delivery site.”
Why the change from EPRs to EDDOs? As my observations below will illuminate, the change not only clarifies nomenclature, but also clarifies fundamental concepts related to device and product design.
As for nomenclature, many in the industry believe that the changes were made to avoid confusion with other standards that employ similar terminology. For example, IEC 60601 uses the term essential performance in addressing safety and performance for medical electrical equipment. As for concepts, many in industry viewed EPRs as correlating with design inputs. The new guidance clarifies that EDDOs are, rather, a subset of design outputs and are, therefore, inherent to design features. That clarification in terminology now better aligns with standard design control terminology, including the term design outputs.
Questions Abound About EDDOs
To help industry understand the new guidance, Drug Delivery Leader coordinated a DDL Live! virtual event, The FDA Guidance on EDDO: What To Know, What to Do. I moderated the panel discussion featuring two well-known industry experts: Alan Stevens, former director at CDRH and currently in a regulatory leadership role at AbbVie, and Susan Neadle, formerly of J&J and currently president of her own consulting firm, Combination Products Consulting Services LLC.
At the outset of the session, we polled the webinar attendees about the degree to which the new EDDO guidance answers critical questions industry had about EPRs and clarifies understanding. The audience response indicated that, although the guidance is generally considered to be helpful, many areas for added clarity remain. In fact, less than 2% of the respondents feel fully confident in their understanding of EDDOs. The questions they submitted during the session further illustrated these acknowledged gaps in understanding.
Among the topics we addressed during the session were the following:
- How EDDOs compare to primary functions
- The difference between dependent and independent outputs
- Verification and validation of EDDOs
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The recent FDA draft guidance