US FDA Guidance for Industry Apr – Jun 2025

DateTitle of guidance and link to documentType and level
of guidance		About the guidance
26 Jun 2025

(Medical Devices)		Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket SubmissionsFinal This guidance is applicable to devices with cybersecurity considerations, including but not limited to devices that include a device software function or that contain software (including firmware)
or programmable logic. The guidance is not limited to devices that are network-enabled or contain other connected capabilities. This guidance describes recommendations regarding the cybersecurity information to be submitted for devices under the following premarket submission types, when submitted to the Center for Devices and Radiological Health (CDRH) or the Center
for Biologics Evaluation and Research (CBER):

• Premarket Notification (510(k)) submissions;
• De Novo requests;
Premarket Approval Applications (PMAs) and PMA supplements;
• Product Development Protocols (PDPs);
•Investigational Device Exemption (IDE) submissions;
•Humanitarian Device Exemption (HDE) submissions;
• Biologics License Application (BLA) submissions; and
• Investigational New Drug (IND) submissions.
26 Jun 2025Conducting Remote Regulatory Assessments Questions and AnswersFinal
In response to the Coronavirus Disease 2019 (COVID-19) pandemic, FDA adapted its operations for field activities to provide oversight of regulated industry while mitigating the spread of COVID-19. One set of tools used during the COVID-19 public health emergency for oversight of FDA-regulated products was remote regulatory assessments (RRAs). The term “RRA” (as defined in the Question and Answers section) is used to describe a category of activities for which FDA may use different terminologies, but
that are all considered to be types of RRAs, including “remote interactive evaluations” and “remote record reviews

The Agency believes that FDA’s use of both mandatory and voluntary RRAs, as applicable, for FDAregulated products is in the interest of the public health, and the Agency is issuing this guidance to
provide further transparency to interested parties about the circumstances in which the Agency may opt to use mandatory and voluntary RRAs.

The Agency is also issuing this guidance to promote greater consistency in the manner RRAs are conducted, including by explaining processes for responding to an RRA request, and by outlining factors
we use for evaluating whether an establishment has responded timely and appropriately to a mandatory
request.
26 June 2025

Submit comments by 24 Sep 2025		Unique Device Identifier Requirements for Combination ProductsDraftThis document is intended to assist industry and FDA staff in understanding how FDA’s unique
device identifier (UDI) requirements at 21 CFR part 801 subpart B and part 830 subpart E apply
to combination products with device constituent parts. This guidance outlines the requirements,
recommendations, and best practices for UDI labeling and for submission of information to the
Global Unique Device Identification Database (GUDID) for such combination products. This
guidance also provides some hypothetical examples to illustrate how UDI requirements can be
met for these combination products.
23 Jun 2025Q1 Stability Testing of Drug Substances and Drug ProductsDraftThis guideline outlines the stability data expectations for drug substances and drug products. This guideline is applicable to marketed drug products, including those associated with registration and lifecycle/post-approval changes and, when applicable, master files. These applications are hereafter
collectively referred to in the guideline as regulatory submissions. ICH Q1 is a consolidated revision that supersedes ICH Q1A-F and Q5C guidelines and provides additional guidance on principles relating
to stability. This guideline applies to synthetic and biological drug substances and drug products.
13 Jun 2025ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug SubmissionsFinalThe FDA is issuing this guidance to incorporate program
enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC) within the abbreviated new drug application (ANDA) assessment program agreed upon by the Agency and industry as part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance
Goals and Program Enhancements, Fiscal Years 2023 through 2027” (GDUFA III commitment letter). This guidance replaces the draft guidance for industry on ANDAs: Pre-Submission
Facility Correspondence Related to Prioritized Generic Drug Applications (December 2022).
5 Jun 2025M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)DraftThis template is intended for interventional clinical trial protocols and is suitable for all phases
and therapeutic areas of clinical research. Interventional trials may include but are not limited
to human pharmacology, exploratory, confirmatory and post-approval trials. The template is
designed to enable modification suitable for the particular trial. Refer to the sections in the document for
additional details and conventions related to flexibility.
5 Jun 2025
M11 Technical Specification: Clinical Electronic Structured Harmonised ProtocolDraftThe purpose of this document is to serve as a technical representation of the ICH M11
protocol template. This Technical Specification (TS) is aligned with the latest version of the
ICH M11 Guideline and protocol template, but with flexibility in addressing data exchange
needs per ICH and those of regional authorities.
4 Jun 2025

(Medical devices)		Transfer of a Premarket Notification (510(k)) Clearance – Questions and AnswersDraftThis guidance provides information on the most frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. Under section 510(k) of the FD&C Act and its implementing regulations, any person required to register under 21 CFR 807.20 who plans to introduce a device into commercial distribution for the first time must, per 21 CFR 807.81(a)(2), submit a premarket notification submission, or “510(k),” if that device is not exempt from 510(k) requirements. This guidance discusses topics related to a transfer or sale of a 510(k) clearance in which the submission of a new 510(k) would not be required, and instances in which entities must use the existing 510(k) number to list a device.
30 May 2025M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths BiowaiverDraft This guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage
forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and
hgranules/powders for oral suspension.