Category: Uncategorized

FDA’s QMSR Final Rule: What Manufacturers Need to Know

Posted on by Brandon Miller

Listen to hear RCA’s Director of Regulatory Affairs, Jordan Elder, review the key differences regarding the new Quality Management System Regulation (QMSR) final rule and the current Quality System Regulation (QSR).

The FDA has recently issued the Quality Management System Regulation (QMSR) final rule, marking a significant update to the longstanding Quality System Regulation (QSR). This change is designed to harmonize medical device quality system requirements with the globally recognized ISO 13485 standard. While the original QSR emphasized product safety and effectiveness through rigorous FDA oversight, the new QMSR aims to reduce regulatory redundancies and streamline compliance, aligning more closely with international standards. This regulatory shift promotes a unified approach to global market access, making it critical for manufacturers to understand and implement the updated requirements.

The QMSR rule is set to take effect on February 2, 2026. The FDA has made it clear that enforcement will begin immediately upon implementation, and manufacturers must be fully compliant by this date. Firms that fail to comply with the updated requirements may be subject to 483 observations and warning letters during future FDA inspections.

Key Differences Between QSR and QMSR

While the fundamental principles of ensuring device safety and effectiveness remain unchanged, several critical updates distinguish QMSR from its predecessor:

  • Terminology Updates: The QMSR aligns with ISO 13485 terminology, replacing FDA-specific terms used in QSR. For example:
    • Design History File (DHF) becomes Design and Development File
    • Design Master Record (DMR) transitions to Medical Device File
    • Device History Record (DHR) aligns with ISO-equivalent documentation
  • Risk Management Integration: The previous QSR addressed risk management implicitly through various regulatory requirements. The new QMSR explicitly incorporates risk management throughout the device lifecycle, aligning with ISO 14971. While compliance with ISO 14971 is not mandatory, manufacturers must now adopt a proactive and systematic approach to risk assessment and mitigation.
  • Enhanced Design Controls: The QMSR refines design control processes by fully integrating ISO 13485’s design and development requirements. Where the QSR set specific design control mandates, the QMSR ensures manufacturers adhere to globally recognized best practices.
  • Stronger Supplier Management Requirements: Under QMSR, manufacturers must establish quality agreements and ensure supplier compliance with regulatory requirements. This added emphasis on supplier management reflects an industry-wide shift toward accountability throughout the supply chain.
  • Updated Labeling and Packaging Controls: While QMSR retains the labeling and packaging control requirements from QSR, it places a greater emphasis on verification and inspection processes to enhance quality assurance and reduce compliance risks.

What This Means for Manufactures

To ensure seamless compliance with QMSR, manufacturers must take the following proactive steps:

  • Revise Quality Documentation: Update quality manuals, procedures, and records to reflect the new terminology and requirements.
  • Personnel Training: Educate employees on the new standard and its implications for day-to-day operations.
  • Strengthen Risk Management Processes: Implement systematic risk assessment and mitigation strategies in alignment with the new regulatory framework.
  • Update Supplier Agreements: Review and modify existing supplier agreements to ensure alignment with QMSR requirements.
  • Plan for a Smooth Transition: Manufacturers should initiate internal audits, update compliance strategies, and engage regulatory professionals to facilitate a successful transition before the enforcement date.

The QMSR final rule represents a pivotal shift in regulatory oversight, providing a streamlined, internationally aligned framework for medical device manufacturers. Preparing now will help ensure compliance, avoid regulatory scrutiny, and support continued success in the global market. Manufacturers should act swiftly to integrate these changes into their quality systems and maintain a proactive approach to FDA compliance.

How RCA Can Help

At Regulatory Compliance Associates® (RCA), we specialize in guiding manufacturers through regulatory changes. Our expert team can help your organization transition to the new QMSR by conducting comprehensive GAP assessments, developing a tailored remediation strategy, and assisting with implementation as needed. Ensuring compliance with evolving FDA regulations is crucial, and RCA is here to support your team every step of the way.

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected]

Changes in Drug Labeling & Transparency

Posted on by Brandon Miller

The FDA is cracking down on labeling for drug products that will require companies to reevaluate and make changes to new and existing products if they wish to stay in compliance. To ensure companies can continue production without slowdowns, it is important to understand what changes are being implemented and how they will affect your products.

 

Greater Transparency in NDA and ANDA Labeling

In April 2024, the FDA released a draft guidance aimed at improving transparency in drug labeling, particularly for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), which cover generic drugs. Generic drug labeling must contain information to show that the proposed labeling is the same as that for the Reference Listed Drug (RLD), with certain permissible differences. Under 21 CFR 314.50, an NDA must contain a list of all components used in the manufacture of the drug product.  However, historically, there have been several instances whereby the NDA did not disclose all of its ingredients in the labeling,   leading to complications in the regulatory approval process for generic versions. This lack of transparency created delays and regulatory hurdles for ANDAs that relied on accurate ingredient information from their RLD.

 

Moving forward, the FDA is advocating for clearer and more comprehensive ingredient disclosures on NDA and ANDA labels. For example, labeling for non-oral drug products may need to contain the names of all inactive ingredients with limited exceptions.  This shift is intended to eliminate unnecessary review delays and improve the efficiency of ANDA approvals. While the exact compliance strategies remain unclear, the draft guidance from April 2024 is expected to shape regulatory expectations well into 2025 and beyond once the guidance becomes finalized.

 

This change marks a significant step toward improving the drug approval process. Greater transparency in ingredient listings will not only help generic drug manufacturers but also ensure that healthcare providers and consumers have access to complete information about their medications. The push for increased clarity aligns with broader FDA efforts to enhance drug safety and efficacy.

 

New Labeling Rules for OTC Drugs

Another critical update in drug labeling comes with the final rule for non-prescription (over-the-counter, or OTC) drugs under the Additional Condition of Nonprescription Use (ACNU) framework. Published in December 2024, this rule introduces new labeling requirements for certain OTC products to enhance consumer safety and regulatory oversight.

 

Under the ACNU framework, some OTC drugs will require additional steps before consumers can access them. These measures may include visiting the manufacturer’s website or completing a brief manufacture’s to determine whether the product is suitable for individual use. This regulatory approach seeks to strike a balance between expanding consumer access to safe and effective nonprescription medications while ensuring that people use them appropriately.

 

The implementation of this rule could significantly impact both consumers and pharmaceutical companies. On one hand, it enhances safety measures by ensuring that individuals receive proper guidance before using certain OTC drugs. On the other hand, companies will need to update their packaging, labeling and digital platforms to comply with the new requirements. Consumers may also need to adapt to these changes by engaging with manufacturers’ resources before purchasing certain OTC products. The final rule is intended to increase options for consumer access to appropriate, safe, and effective drug products, which could improve public health.

 

What to Expect

These labeling and transparency initiatives will likely play a major role in shaping the pharmaceutical landscape in the future. The FDA’s push for improved ingredient disclosure in NDAs and ANDAs is expected to streamline generic drug approvals and foster greater trust in drug labeling. Meanwhile, the ACNU framework will redefine how consumers interact with select OTC medications, prioritizing informed decision-making and responsible use.

 

Stakeholders, including drug manufacturers, healthcare providers, and consumers, should stay informed about these evolving regulations to ensure compliance and safe medication practices. As the FDA continues refining its policies, further clarifications and potential updates may emerge, reinforcing the agency’s commitment to transparency and consumer safety in the pharmaceutical industry.

 

Preparing for These Changes

For companies looking to stay ahead of these regulatory updates and maintain seamless approvals and production, it is essential to assess current processes and identify gaps in compliance with the new FDA guidelines. Engaging with third-party auditors with relevant expertise can help pinpoint deficiencies and develop a robust implementation strategy, ensuring compliance from the outset.

 

At RCA, we leverage our extensive network of industry experts, including former FDA consultants and leading auditors, to provide comprehensive support. Whether identifying and addressing compliance gaps or designing entirely new processes for emerging products, our team ensures a seamless transition to meet evolving regulatory expectations. Let us help you identify any gaps and help you form a clear strategy that will keep your drug labels in compliance today.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

 

Strategic Consulting Services

Posted on by Brandon Miller

About RCA’s Strategic Consulting Services

Whether it’s a corporate needs analysis, corporate growth/transformation initiative or due diligence/acquisition, Regulatory Compliance Associates (RCA®) worldwide experience can help ensure a successful mix of top-notch advice and people so your strategy is on time, and on budget — and you’re never embroiled in a costly mistake.

 

Follow the links below to learn more about our strategic consulting services in Pharmaceuticals and Medical Devices. 

 

Pharmaceuticals

Medical Device

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Remediation Consulting Services

Posted on by Brandon Miller

About RCA’s Remediation Services

Regulatory Compliance Associates has significant quality and regulatory compliance consulting experience and a proven regulatory framework for managing FDA  483’s, Warning Letters, and Consent Decrees. Our pharmaceutical consultants know how to partner with executive, legal, and communication teams at all levels of a life science company. RCA’s remediation consulting experts can assist your management with a remediation strategy that is accepted by the regulatory agency and realistic to execute internally.  Finally, RCA can partner with your leadership team to develop a long-term risk management plan to help your team stay in compliance going forward.

 

Regulatory Compliance Associates can assist with answering FDA 483 observations, FDA Warning Letters and developing strategies to help your organization maintain regulatory compliance through continuous improvement.

 

RCA can help with remediation activities in both manufacturing operations & quality management systems.  RCA’s regulatory consultants have completed many projects assisting our clients to evaluate what is needed, collaboratively determine action plans & help execute.  We have also performed post-implementation audits to ensure regulatory compliance.

 

Follow the links below to learn more about our remediation services in Pharmaceuticals and Medical Devices. 

 

Pharmaceuticals

Medical Device

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Compliance Consulting Services

Posted on by Brandon Miller

About RCA’s Compliance Assurance Services

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance Associates® team of compliance consultants can help. Our business consultant Experts are internationally known in the regulatory compliance consulting industry.

 

The regulations process surrounding life science companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA®, we offer the management consulting resources necessary to guide you in regulatory compliance.

 

Follow the links below to learn more about our compliance assurance services in Pharmaceuticals and Medical Devices. 

 

Pharmaceuticals

Medical Device

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

FDA Guidance on Postmarket updates to AI-enabled devices

Posted on by Brandon Miller

What is a pre-determined change control plan (PCCP)?

The FDA recently released a final guidance on regulating AI-enabled medical devices that focuses on how manufacturers can modify these devices after they are authorized. The agency introduced a new regulatory framework called pre-determined change control plans (PCCPs), which allows certain post-market changes to devices using AI or machine learning. PCCPs were first mentioned in a 2019 discussion paper, and the FDA has since issued draft and final guidance on them.

 

PCCP Required Information

This final guidance outlines the required information for PCCPs, which includes;

  • Description of Modifications – The specifications for the characteristics and performance of the planned modifications to the device;
  • Modification Protocol – The associated verification and validation testing activities that will support the planned modifications and acceptance criteria to assure the device remains safe and effective across the intended use populations
  • Impact Assessment – The assessment of the benefits and risks of implementing a PCCP, as well as the plan for risk mitigation.

Need help establishing a PCCP for your medical device?

Contact Us Now!

Manufacturers can propose updates to AI models, such as re-training to improve accuracy, without needing new submissions, as long as the changes stay within the device’s intended use. However, significant modifications outside the scope of the PCCP, like altering a device’s function or user base, would require new FDA submissions.

 

How do you establish a pre-determined change control plans (PCCPs) for my medical device?

Premarket authorization for AI-enabled devices with a PCCP must be established through the PMA pathway, 510(k) pathway, or De Novo pathway as a PCCP must be reviewed and established as part of a marketing authorization.

 

Follow the link to learn more about RCA’s Medical Device Product Approval Support and Submission Services.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].