FDA’s generative AI consultation closes: What should medical device manufacturers do next?

As the FDA considers how generative artificial intelligence should be regulated within medical devices, manufacturers face a growing challenge: demonstrating that systems capable of variable and evolving outputs remain safe, effective and under adequate control throughout their lifecycle.

The US Food and Drug Administration (FDA) has reached an important milestone in its consideration of generative artificial intelligence (GenAI)-enabled medical devices. The agency's public feedback period closed on 19 October 2026, following publication of its discussion paper on 18 August. The consultation, led by the FDA's Digital Health Center of Excellence, sought views from manufacturers, clinicians, researchers and other stakeholders on risk assessment, premarket evaluation and postmarket monitoring.

Importantly, the discussion paper is not a new regulation or final guidance. Rather, it provides an indication of the questions the FDA is considering as it develops an appropriate regulatory approach to GenAI-enabled technologies.

Why generative AI presents a different challenge

GenAI does not necessarily behave like conventional medical-device software. Such systems may accept open-ended inputs, undertake multiple subtasks and generate variable outputs from similar inputs. This complicates traditional approaches to verification and validation, where manufacturers seek to establish predictable performance against predefined specifications.

The FDA discussion therefore points towards risk-proportionate oversight. One concept under consideration is a two-axis approach to risk assessment, alongside competency-based approaches to premarket evaluation.

For manufacturers, the practical implication is that demonstrating satisfactory performance prior to market entry may not be enough. An AI system's behaviour in its intended clinical environment and its performance through the product lifecycle are likely to become increasingly important considerations.

This makes postmarket monitoring particularly significant. Manufacturers should consider how changes in performance can be detected, investigated and controlled, and how evidence generated after deployment feeds back into the product's risk-management process.

Compliance becomes increasingly important

These discussions also coincide with a potentially significant change in the US enforcement environment.

On 1 October, the Department of Justice issued Directive 26-12, Corporate Enforcement in the Fight Against Fraud. The directive calls for an “all-tools” approach towards specified fraud priorities and explicitly includes healthcare fraud, controlled-substance distribution and violations of the Federal Food, Drug, and Cosmetic Act among priority areas.

Legal commentators consequently suggest that FDA-regulated pharmaceutical and medical-device companies could face enhanced scrutiny. This does not mean that every regulatory deficiency will result in DOJ action, but it reinforces the value of effective compliance systems, internal controls, investigation processes and timely remediation.

What should manufacturers do now?

The FDA has not yet established final GenAI-specific requirements, so companies should avoid treating the concepts in the discussion paper as settled regulatory expectations. Nevertheless, manufacturers can prepare.

A sensible starting point is to examine existing quality and risk-management systems against the particular characteristics of GenAI. This should include clearly defining intended use, identifying safety-critical outputs and foreseeable failure modes, determining how performance will be challenged before deployment, and establishing appropriate mechanisms for detecting deterioration or unexpected behaviour afterwards.

Change control will be another critical consideration. Organisations will need to understand what aspects of an AI-enabled device may change, how those changes could affect validated performance and when additional assessment becomes necessary.

The central message is therefore familiar to pharmaceutical and medical-device quality professionals: innovation does not remove the requirement for control. As GenAI becomes increasingly sophisticated, evidence of lifecycle governance, risk management, monitoring and effective quality oversight is likely to be just as important as the sophistication of the algorithm itself.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

How to Build Defensible Microbiological Sections in CMC Dossiers?

 

A microbiology laboratory can generate hundreds of results during development. There are bioburden counts, sterility tests, environmental monitoring, endotoxin results, microbial identification, media fills, method suitability data, and stability observations. On their own, these results are useful laboratory records. But the question is how does a regulatory reviewer relate the results to the quality of the drug product?

 

Here comes the concept of traceability. It is needed to make microbiological information defensible during submission to regulatory authorities. So, the challenge is not just to generate microbiology data. It is to turn it into a clear and traceable scientific argument for the regulatory reviewer’s evaluation.

Draft a Microbiological Risk & Control Strategy

Start by analyzing the product and processing microbiological risks. Check which can be controlled. Every pharmaceutical product doesn’t have the same risk. For example, the risk picture of a non-oral sterile liquid that could adversely affect the product may include the following:

·         Microbial proliferation in aqueous ingredients

·         Contamination introduced through equipment or water

·         Survival of objectionable microorganisms

Applying a control strategy here, especially for an aseptically manufactured injectable, is very different. It may involve sterilizing filtration, pre-filtration bioburden, environmental monitoring, container and closure preparation, aseptic process simulations, sterilization or depyrogenation processes, and finished-product sterility and endotoxin testing.

The FDA provides CGMP information that helps in differentiating the controls that are needed for non-sterile and sterile drug products. Non-sterile product manufacturers must have procedures to prevent objectionable microorganisms. Sterile products must also have written procedures that prevent microbial contamination.

Thus, the implications for reliable CMC writing are important.

Placement of Microbiology Information in the CMC Dossier

One usual misconception is that microbiology data belongs in a single section of Module 3. FDA MAPP 5040.1 provides a practical map for microbiology information in NDA and ANDA submissions. So, relevant information can appear across several CTD-Q sections. Here is the example:

·        3.2.P.2.5 — Microbiological Attributes

Information concerning microbiological attributes. It covers container closure/package integrity, preservative effectiveness, and justification where a microbial-limit specification is not included for a non-sterile product.

·        3.2.P.3.3 — Manufacturing Process and Controls

Relevant information on sterilization, depyrogenation, environmental monitoring, product bioburden, filtration, and holding periods. It is according to whatever applies to the manufacturing process.

·        3.2.P.3.5 — Process Validation and/or Evaluation

Sterilization validation, microbiological efficacy, bioburden characterization, media fills, and related validation evidence where applicable.

·        3.2.P.5.1–P.5.3—Product Specifications, Analytical Procedures, and such Procedure Validation

Information relating to attributes such as sterility, endotoxin, and microbial limits.

·        3.2.P.8.3 — Stability

It relates to the microbiological testing and testing schedule that monitors microbiological quality during storage. FDA MAPP 5040.1 identifies relevant container closure integrity/sterility, endotoxin, and microbial-limit testing.

·        3.2.A.2 — Adventitious Agent Safety Evaluation

This is important where the product or manufacturing process presents an applicable adventitious agent risk.

This means the dossier should be written as a connected story. There shouldn’t be repetition of the same microbiology information in every section.

What Makes Microbiological Data Defensible?

A defensible microbiological section is more than a collection of passing results. Four connections should be visible.

1.   What quality attribute or risk is being assessed?

A test should have a clear aim. For example, microbial enumeration may be used to assess the microbiological quality of a non-sterile product. Similarly, sterility testing becomes a part of the controls for a product required to be sterile.

2.   Is the analytical method apt for the product?

The product itself can interfere with microbiological recovery. Therefore, simply stating that a pharmacopeial method was used may not be enough. USP General Chapter <1227> explains that use of compendial microbiological procedures requires demonstration of method suitability for the product, including recovery of challenge organisms in the presence of the product. The submission should prove that the method is apt for the purpose it’s for.

WHO guides pharmaceutical microbiology laboratories, letting them address the performance and control of examination procedures and laboratory practices.

3.   What makes the acceptance norm appropriate?

Along with the specification, the CMC section should provide the scientific and regulatory reasoning that backs the chosen test and acceptance standard.

4.   Can the result be traced back to its source?

The result that’s submitted should be traceable to the batch it came from. Also, with the test method, specification, and quality records. Deviations, atypical results, or investigations that affect interpretation should be addressed properly.

Illustrative Examples of the CMC Stories

Here are some examples to explain the significance of this topic:

Example 1: Turning Sterility-Assurance Data Into a CMC Narrative

Take an aseptically filled injectable. It is manufactured using sterile filtration. A weak dossier statement might simply say that the product passed sterility testing. Also, that environmental monitoring was acceptable.

A stronger submission connects the evidence. It can describe the following:

·         Pre-filtration bioburden control

·         Sterilizing filtration process and its validation

·         Sterile preparation of containers and closures

·         Aseptic processing controls

·         Environmental monitoring

·         Media-fill qualification

·         Finished-product sterility

·         Endotoxin controls

FDA’s CTD-Q microbiology policy explicitly identifies all of this at their relevant CTD locations. The point is not to reproduce every laboratory record in the application. It is to show how the individual datasets support the sterility-assurance strategy.

Example 2: Non-Sterile Products Require a Different Chain of Proof

What if development considers water quality and microbial proliferation as huge risks? Such cases require a robust dossier. Yours should be able to connect water system, component, and manufacturing process controls. Further, it should consider preservative strategy, microbial enumeration, testing for specified microorganisms, and stability monitoring.

Officially, USP <61> is used for quantitative enumeration of aerobic mesophilic bacteria and fungi. USP <62> addresses specified microorganisms. FDA’s 2021 draft non-sterile drug guidance also stresses that manufacturers should prevent the introduction and proliferation of objectionable microorganisms. They must use appropriate microbiological controls.

So, make sure that the control strategy shows the collective working of formulation, process, facility, and testing.

Common Problems When Converting Microbiology Data Into CMC Content

Several problems can make microbiological information difficult for a reviewer to interpret. These include the following:

1.   Reporting results without explaining their purpose

A table showing microbial counts won’t be that useful when the submission lacks an explanation of which quality attribute or manufacturing risk the testing addresses.

2.   Providing specifications without sufficient rationale

The acceptance criterion should have a scientific basis that is appropriate to the product and regulatory framework.

3.   Treating compendial methods as automatically product-independent

The relevant method suitability work should be addressed where the product can interfere with microbial recovery or detection.

4.   Separating related evidence

Look into it with an aseptic product example. It may require environmental monitoring, media fills, sterilization or filtration controls, and sterility testing. Although separate, they need to come together. Then, they can support the contamination-control strategy.

5.   Same information repeating across multiple CTD sections

There can be inconsistencies due to poor cross-referencing. It may make microbiology information appear across Module 3. So, the objective should be consistency with proper cross-referencing and no duplication.

Practical Tips for the Microbiology Section

Create a simple microbiology traceability matrix before drafting.

Question	Information to capture
What is the risk?	Microbial contamination, proliferation, sterility, endotoxin, etc.
Where is the risk controlled?	Formulation, raw materials, facility, process, packaging, or testing
What is tested or monitored?	Microbial limits, sterility, endotoxin, environmental monitoring, bioburden, etc.
Which method is used?	Compendial or validated/qualified method
Is the method suitable?	Product-specific suitability or validation evidence
What is the acceptance criterion?	Defined specification or process criterion
What does the data show?	Product quality or process-control conclusion
Where does it belong in CTD?	Relevant Module 3 section

This exercise can expose gaps before submission. For example, if the specification identifies a microbiological test. However, the development section does not explain why that attribute matters. Or if the manufacturing narrative describes a microbial control without corresponding process evidence. This gap can be addressed before regulatory review.

Don’t Add More Data Without Traceability

A microbiological CMC section that is strong does not really have the largest possible volume of laboratory data. Its value comes from showing a clear chain:

Risk → Control → Method → Acceptance Basis → Result → Regulatory Conclusion

This chain is what helps reviewers understand what the microbiology laboratory found. It also explains why the result matters to the quality of the drug product. This is particularly important when microbiological information is distributed across different CTD sections. FDA's MAPP 5040.1 itself reflects this cross-sectional approach by directing microbiology reviewers to relevant information throughout CTD-Q rather than treating it as a standalone dataset.

Conclusion

Microbiology data on its own is not strong enough for CMC evidence. That’s because it emerges from controlled laboratory conditions. It becomes valuable from a regulatory perspective when there’s a connection as explained in the chain.

CMC authors should thus understand. They need not copy laboratory reports into Module 3. They should explain the scientific meaning of those results. Then, place them where they support the relevant quality argument. This clear chain is what lets a reviewer move from the microbiological result to the manufacturing control.

Ultimately, they can reach the product-quality conclusion. There won’t be any need to reconstruct the rationale themselves.

Meta Title: From Microbiology Data to CMC Dossiers | Regulatory Submission

Meta Description: Learn to turn microbiology data into a defensible CMC dossier by linking risks, controls, analytical methods, acceptance criteria, and regulatory evidence.

What Has the Biggest Impact on an ISO 27001 Certification Timeline?

When pursuing an ISO 27001 certification, most organizations may assume the audit stages will determine how long the process takes. The real timeline driver lies in the readiness work that occurs before Stage 1 begins, in the implementation gaps that surface between audit phases. Organizations can spot where delays actually originate to cut months off the certification journey.

By Emily Newton 

Readiness and Gap Assessment Set the Pace

The pre-audit phase determines how fast the ISO 27001 certification timeline moves. Gap assessments, documented information development, risk treatment plans and employee awareness programs consume the bulk of effort before Stage 1 auditors arrive.

 

The global ISO 27001 certification industry’s market size reached $18.59 billion in 2025 and is expected to reach $74.56 billion by 2035. Such growth is reportedly driven by rising cyber threats, regulatory compliance requirements and accelerating adoption of information security frameworks.

 

The scope of readiness work covers the entire organization. "ISO 27001 system requires all employees, contractors and third parties to be aware of information security threats, fulfill their information security responsibilities and reduce human errors. A long-term cyclical training program is also required to ensure employees become familiar with certification requirements," researchers note in a study on the effects of certification and concealment on company performance.

What the Stage 1 Audit Actually Reviews

Stage 1 audits cover documentation and design reviews. The information security management system (ISMS) must be documented and meet ISO 27001 requirements before auditors can validate its design. Auditors then examine scope statements, risk assessment methodologies and documented information architectures.

 

At this point, the goal is to confirm the organization has identified information security risks, chosen appropriate controls and established processes to address those risks. Whether controls operate effectively in practice will be tested later. Incomplete documentation delays the process as findings need remediation before Stage 2 can proceed.

What the Stage 2 Audit Demands of an ISMS

Stage 2 prioritizes operational testing. The ISMS must function as designed and deliver outcomes in day-to-day operations. Auditors interview personnel to confirm awareness of security policies, inspect evidence of risk treatment implementation and validate that monitoring processes capture security events.

 

Incident response records, access control logs and internal audit results all come under scrutiny. The gap between what is documented and what actually happens surfaces at this point. Employee awareness programs may exist on paper, but lack evidence of completion, or risk assessments remain theoretical without follow-up mitigation activities. These shortfalls can further extend the schedule.

Ways to Speed Up Certification

Strategic preparation is critical to the ISO 27001 journey. A thorough gap assessment before engaging a certification body lets an organization fix deficiencies early while locking in audit resources when needed.

 

"The general public is now much more conscious of what personal information organizations are allowed to hold, the reasons they hold it and whether they have been given permission to use it or not," according to NQA, an accredited certification body.

 

The standard increasingly serves as a procurement gateway because many contracts list ISO 27001 as a condition of supply. Treating this credential as a strategic capability can deliver faster time-to-market while opening new business opportunities.

Why Certification Timelines Still Vary

The finance, healthcare and technology sectors each face regulatory pressures that shape ISO 27001 schedules differently. The scope of information and security requirements affects how long gap remediation and audit preparation take.

 

Pharmaceutical and medical device manufacturers contend with FDA cybersecurity requirements under Section 524B of the Federal Food, Drug and Cosmetic Act. This directive took effect March 29, 2023, and was reinforced by final guidance issued June 27, 2025. These regulatory overlays expand the scope of controls an organization must demonstrate during audits.

 

Why schedules vary comes down to how risk management is woven into operations. "Research organizations manage increasingly complex data, technologies, platforms and workflows, so information security has to be built into how the organization operates, not treated as a separate IT function," says Ironwood Insights Group, a strategic market research firm.

 

This integration becomes even more important as the nature of threats evolves. "With cybercrime on the rise and new threats constantly emerging, it can seem difficult or even impossible to manage cyber-risks,” says the ISO itself on its official website. “ISO/IEC 27001 helps organizations become risk-aware and proactively identify and address weaknesses."

Frequently Asked Questions About ISO 27001 Certification Timelines

Organizations evaluating ISO 27001 commonly ask specific questions about audit duration and schedule drivers.

What affects the ISO 27001 certification timeline the most?

Pre-audit readiness work affects the process more than the audit duration does. Gap assessments and risk treatment controls before Stage 1 begins compress the overall schedule.

How long are the ISO 27001 Stage 1 and Stage 2 audits?

Stage 1 and Stage 2 audit durations depend on organizational size and information security scope. Each audit stage typically spans days. The months between stages, when the organization addresses findings, make up the longer stretch.

How long does the full ISO 27001 certification timeline take?

The full process varies based on readiness at the start of the project. Organizations with mature information security practices can complete it in months. Building an ISMS from the foundation level takes longer, as the company develops controls and establishes operational evidence. 

The Real Timeline Driver Behind ISO 27001 Certification

Readiness controls the clock. The difference between a fast certification and a protracted one comes down to how much gets accomplished before auditors arrive. Organizations that front-load gap assessments and implementation work set themselves up for smoother passage through both stages. The smartest approaches treat information security management as an ongoing discipline rather than a project with an end date.