FDA Revises Drug Delivery Device Draft Guidance in October 2026: “Outputs” Renamed “Performance Characteristics,” Comments Due by January 28, 2027

FDA Revises Drug Delivery Device Draft Guidance: “Outputs” Becomes “Performance Characteristics,” Comments Due by January 28, 2027

Published: October 31, 2026, 13:58 | Category: Registration and Market Access

A Draft Guidance With a New Name

On October 30, 2026, the U.S. Food and Drug Administration (FDA) published a notice of availability in the Federal Register (91 FR 68523) announcing that a revised draft guidance has been opened for public comment. The draft is titled “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products.”

Its predecessor was the draft guidance announced in the Federal Register on July 1, 2024, titled “Essential Drug Delivery Outputs Intended to Deliver Drugs and Biological Products” (89 FR 54470). The notice for the new draft explicitly states that it “revises and replaces” the 2024 draft. The most significant change in the title is the replacement of “outputs” with “performance characteristics.”

Which Products Are Covered

The scope stated in the notice is clear: devices intended to deliver human drugs, including biological products, as well as combination products that contain a device constituent part. The document refers to this product category collectively as drug delivery devices.

In practical terms, prefilled syringes, autoinjectors, pen injectors, infusion pumps, nasal spray and nebulizer devices, and combination products that are packaged with a drug and in which the device performs the delivery function all fall within the scope of this document. The draft guidance focuses on whether a device’s drug delivery function can be reliably achieved as intended, and provides recommendations on what information and data should be submitted in relation to that question.

What the Revision Aims to Address

The background section of the notice sets out two objectives for the revision. First, to clarify the testing and control aspects of device drug delivery performance; second, to align with the revised quality management system regulation 21 CFR part 820.

These two statements are brief but pointed. Testing and control address how performance is demonstrated; alignment with the QMSR addresses under which system documentation it is demonstrated. The former concerns the performance data itself, while the latter concerns how design controls, risk management and change management are embedded in the quality management system. For drug delivery device companies preparing U.S. submissions, these two matters are inherently connected.

Three Submission Scenarios Covered

The guidance page states that the document focuses on the information and data that should be submitted in investigational applications, marketing applications and post-marketing change applications. In other words, it does not apply only to initial submissions; it also brings post-marketing changes within its scope.

This is particularly relevant for drug delivery devices. Changes to device geometry, dose graduations, driving force or container closure structure may each affect delivery performance and, in turn, affect the materials required in a change application. Addressing all three submission categories in a single document effectively requires companies to maintain a consistent approach to describing performance throughout the product lifecycle.

Issuing Offices and Binding Status

The draft was issued jointly by several FDA offices: the Office of Combination Products (OCP) within the Office of the Commissioner, the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER). The four co-signatories indicate that the document spans the drug, biological product and device lines.

The guidance page also states the status of the draft: not for implementation and contains non-binding recommendations. It is therefore a draft for comment and does not constitute a mandatory requirement; until the final version is issued, it should not be cited directly as a basis for review. This point should be communicated clearly internally to avoid misinterpretation as an immediately effective new rule.

Timeline and How to Submit Comments

The deadline for submitting comments is January 28, 2027. The notice states that comments submitted by that date will be considered by FDA before it begins work on the final version. The docket number is FDA-2024-D-2560, and comments are submitted through the U.S. federal electronic rulemaking platform.

It is important to note that FDA’s comment channel for guidance documents remains open at all times, and comments may be submitted at any point. However, to have comments included in the pre-finalization considerations, they must be submitted before January 28. These two points are frequently confused.

Docket link: https://www.regulations.gov/docket/FDA-2024-D-2560

Sources and Scope of Verification

Source: U.S. Food and Drug Administration (FDA) — “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability,” Federal Register 91 FR 68523, published October 30, 2026, Docket No. FDA-2024-D-2560.
https://www.federalregister.gov/documents/2026/10/30/2026-22203/essential-drug-delivery-performance-characteristics-for-devices-intended-to-deliver-drugs-and

Source: FDA guidance page, “Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products” (Draft Guidance for Industry, October 2026; page content noted as updated through October 29, 2026), which identifies the issuing offices, the draft status and the comment deadline.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/essential-drug-delivery-performance-characteristics-devices-intended-deliver-drugs-and-biological

Scope of verification and access date: This review covered the text and abstract of the Federal Register notice, the status statement on the FDA guidance page, and the announcement information for the original July 1, 2024 draft (89 FR 54470). Access date: October 31, 2026. The full PDF of the draft guidance was not quoted section by section, and this article does not describe its internal chapters or specific metrics.

Applicability note: This article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. The draft guidance is non-binding and the final version may change; specific submission requirements are subject to the official FDA text and subsequent final documents, and relevant information may change as official updates are issued.

Information Sources

• U.S. Food and Drug Administration (FDA) — Federal Register notice, 91 FR 68523, 2026-10-30
• U.S. Food and Drug Administration (FDA) — Guidance document page

AIMEILI Regulatory Interpretation

The shift from “outputs” to “performance characteristics” is more than editorial. “Outputs” framed the subject narrowly as measurable delivery results — dose accuracy, volume delivered, injection time, breakaway and glide force, and similar indicators. “Performance characteristics” frames it as the set of characteristics that determine whether the delivery function is reliably achieved in use, which naturally draws in device-related attributes that interact with the drug, the container closure system and the human factors of administration. For sponsors, the practical consequence is that the performance story should be constructed as a coherent whole rather than as a list of bench measurements.

Three implications follow for regulatory strategy. First, lifecycle consistency of the performance description. Because the draft addresses investigational applications, marketing applications and post-marketing change applications in one document, sponsors should expect the same performance characteristics framework to be carried from first-in-human studies through approval and into post-approval changes. A change that alters device geometry, dose graduations, driving force or container closure structure should be assessed against that same framework before the change is filed.

Second, alignment with 21 CFR part 820. The explicit reference to the revised quality management system regulation means the performance characteristics and the supporting data should be traceable to design controls, risk management and change control records within the quality management system. Reviewers may test whether the submitted performance data are consistent with the design history file and risk documentation. Companies still operating documentation practices built around the former 21 CFR 820 structure should treat this as a prompt to close that gap now, not at the point of submission.

Third, combination products and jurisdictional coherence. The joint issuance by OCP, CBER, CDRH and CDER signals that the expectations apply across drug-led, biologic-led and device-led combination products. Sponsors of combination products should confirm that the device constituent part’s performance characteristics are described consistently in the drug, biologic and device sections of the submission, since divergent descriptions are a common source of questions during review.

On status: the draft is explicitly non-binding and not for implementation. It should not be cited as an established requirement in submission documents or in correspondence with regulators, and internal teams should be advised accordingly. That said, the directions it sets out are unlikely to be reversed in the final version, and it is reasonable to anticipate finalization in a form substantially similar in structure.

Business Impact

• Submission planning and timelines: Sponsors with U.S. submissions for prefilled syringes, autoinjectors, pen injectors, infusion pumps, nasal sprays or nebulizers should map their current performance data packages against the draft’s framework during the comment period, so that any needed testing or documentation can be scheduled before a final guidance takes effect.
• Change control: Post-marketing change applications are expressly within scope. Companies should review change-assessment procedures to ensure device-related changes are evaluated for delivery performance impact and documented with the same rigour applied at initial submission.
• Quality system readiness: The link to the revised 21 CFR part 820 makes this a quality systems topic as much as a regulatory affairs topic. Design control, risk management and change control records should be able to substantiate the performance characteristics claimed in submissions.
• Combination product coordination: Teams responsible for drug, biologic and device sections of a combination product submission should reconcile performance descriptions before filing to reduce the risk of review questions arising from inconsistency.
• Opportunity to shape the final text: Comments submitted by January 28, 2027 will be considered before FDA begins finalization. Companies with substantive data or concerns on specific performance characteristics, test methods or post-marketing change criteria have a defined window to present their position with supporting evidence.
• Communication risk: Internal and partner communications should state clearly that the draft is non-binding and not for implementation, to prevent it from being treated prematurely as an operative requirement in contracts, supplier agreements or regulatory dossiers.