The FDA’s revised October 2026 draft guidance on drug-delivery device performance is open for comment through January 28, 2027. It focuses on information and data used to establish and assess how devices deliver drugs and biological products, including evidence in investigational, marketing, and post-market change applications. For medical-device employers, the practical question is how the work and decision rights are assigned across existing teams.
The draft is nonbinding and not for implementation. It does not create a hiring mandate, prescribe job titles, or set an organization chart. FDA says the revised draft clarifies recommendations on testing and controlling device drug-delivery performance and aligns with the revised Quality Management System Regulation (QMSR). Use it as a prompt for a product-specific review, not as a reason by itself to open a requisition.
Illustrative laboratory image. Photo by Toon Lambrechts via Unsplash.
What the draft covers
The guidance describes essential drug-delivery device performance characteristics (EDDCs) at the system level. In broad terms, they concern whether a device performs its drug-delivery function as intended, including delivery of the intended dose to the intended site. The document discusses design verification, validation, control, and maintenance of those characteristics through the product lifecycle.
FDA’s examples include syringes, autoinjectors and on-body injectors, infusion products such as pumps, nasal sprays, inhalers, nebulizers, and vaginal systems. The guidance also notes that the relevant characteristics depend on the product. It does not address every other topic that may matter in an application: examples outside its scope include drug-device compatibility, biocompatibility, sterility, human factors, electrical safety, electromagnetic compatibility, wireless technology, and cybersecurity. Those areas may be covered by separate requirements or guidance.
Turn the draft into cross-functional review questions
These are employer-side planning questions informed by the draft. They are not FDA-prescribed job duties or a substitute for review by qualified quality and regulatory professionals.
- Product and performance scope: Which device types and product configurations are in scope, and who understands the system-level function the device must perform?
- Testing and evidence: Who defines or reviews appropriate test methods, acceptance criteria, and the technical rationale for the evidence at the product’s current development or application stage?
- Quality and regulatory handoffs: Which team coordinates the evidence and explains how it supports the relevant investigational, marketing, or post-market change submission?
- Manufacturing and design changes: When a device design or manufacturing process changes, who evaluates whether the change could affect drug-delivery performance and what follow-up evidence is needed?
- Boundaries between disciplines: Which questions belong to other applicable guidance or requirements, and who owns those reviews so that EDDC work is not mistaken for a complete product-safety assessment?
The roles involved will vary with the device, product stage, and company structure. Design or systems engineering, quality, regulatory affairs, and manufacturing engineering may all contribute, but the draft does not require separate positions for each function or imply that a single person should own every decision.
Use the review to define a real hiring need
If an employer finds a capacity or expertise gap, a focused hiring brief can make the search more useful. Define:
- the device types, product configurations, and development or commercial stage involved;
- the specific performance-evidence work the role will own, support, or review;
- the test methods, product knowledge, and level of technical judgment that are genuinely needed;
- which decisions belong to the role and which require approval or input from quality, regulatory, engineering, or operations leaders; and
- the evidence candidates should provide about comparable work, without requesting a former employer’s confidential information.
Start by mapping responsibilities across the current team. If existing employees can cover the work with clear ownership and handoffs, the draft guidance alone does not show a need for another hire. If the review identifies a sustained gap, the job description should name the actual work rather than rely on a broad label such as “FDA experience” or suggest that every employer needs an EDDC specialist.
Keep the regulatory context precise
The October 2026 document revises a June 2024 draft and remains open for comments. FDA asks that comments be submitted by January 28, 2027 for consideration before work begins on a final version. Employers should have their qualified technical, quality, and regulatory leaders determine whether the draft affects their products or existing evidence plans. This article is general employer-side workforce information, not regulatory or legal advice.
Plan the role around the product
For hiring teams, the useful takeaway is to connect device-specific performance work with clear responsibilities and decision rights. The draft is a timely reason to ask how those responsibilities are covered; it is not evidence of new hiring demand or a standalone instruction to add headcount.
HealthStaffingGroup supports employers with permanent placement, contingency search, retained and executive search, and Recruiting Subscription Service for medical-device, MedTech, and medical-manufacturing roles. Explore our medical-device quality and regulatory recruiting practice or request a medical-device hiring consultation.
Primary sources
- FDA: October 2026 revised draft guidance on essential drug-delivery performance characteristics
- FDA: Draft guidance document (PDF)
- FDA: June 2024 draft guidance that the revised draft replaces
- FDA: Quality Management System Regulation (QMSR)
This is general employer-side hiring information, not legal, regulatory, or compliance advice. Employers should confirm product-specific questions with qualified quality and regulatory professionals.
