QSR Compliance :

The medical device industry in the US is highly regulated, as medical product supplied can pose a great threat to the health and safety of humans. The US FDA is the leading regulatory body in the world that has established certain frameworks and regulations to which the medical device manufacturers need to be compliant with for their approval or clearance. FDA has set Quality System Regulation (21 CFR part 820) specifying current Good Manufacturing Practices (cGMP) for medical devices in the industry. Manufacturers developing and supplying medical devices to the U.S. are expected to maintain these stringent quality management systems and be compliant with the code of Federal Regulations 21 CFR 820. Here the system covers a broad range of areas, including production and process controls, Corrective And Preventive Actions(CAPA), product development and management. Manufacturers must adhere to quality systems and ensure that their products consistently meet the requirement as specified by the FDA. Manufacturers supplying medical devices to the US must have complete knowledge and understanding of the regulations and QSR compliance pertaining to medical devices. Since the medical device industry in the US is compliance and regulation-driven industry, the manufacturers must be aware of various medical device regulations and frameworks.

In order to achieve the FDA’s QSR compliance, you must implement a quality system covering the design, manufacture, packaging and labelling storage and delivery of your medical device. For medical device manufacturers seeking regulatory clearance or approval in the US, QSR 21 CFR Part 820 of US codes of Federal Regulations is necessary to meet Quality System Requirements and bring their products to market. Quality System Requirements of 21 CFR Part 820 explain your obligations in the following areas:

Management Responsibilities

Internal quality audits

Design Controls

Process validation

Production and process control

Document and purchasing control

QSR compliance which outlines current good manufacturing practise (cGMP) regulations that control the techniques used in and the efficiency and controls used for, the manufacturing, labelling, packaging, storage, installation, design, and servicing of all finished medical devices predetermined for human use and marketing in the United States of America.

Whether you are a medical device manufacturer offering powerful devices or revolutionary medical equipment that transforms the day-to-day operations of the industry, they must all be compliant to the industry norms set by the FDA. Every manufacturer supplying to the US need to go through the stringent compliances and regulations procedures ensure the safety and effectiveness of the medical devices brought in to the industry. Here is an overview of medical device regulations that every manufacturer needs to know before seeking regulatory clearance and approval for their medical devices in the US.

Medical Device Regulations for manufacturers supplying to the US

In the US, medical devices are regulated by the Food and Drug Administration (FDA) to ensure complete safety of the devices. Here the quality regulation requirements as specified in FDA 21 CFR Part 820 (which is also known as the Quality System Regulation QSR) are broadly pertaining to the methods, facilities, and controls used for the entire medical device, including the purchasing, designing, manufacturing, packaging &labelling, storing, installing and servicing of the devices intended to be used on humans. The FDA mandates emphasise on following quality system requirements for all medical devices seeking for approval. This ensures that the manufacturers meet all the statutory requirements and specifications consistently before supplying their devices to the US.

The FDA’s quality system which is named as Current Good Manufacturing Practices (cGMPs) and forced under part 820 (21 CFR part 820), is authorized by section 520(f) and came to be effective from December 18, 1978. Considering the range of medical devices, the regulation authority simply provides a framework that manufacturers need to follow in order to comply with the regulation. They do not provide any specifications of how the device needs to be improved or made as such. Further, to ensure that all the regulatory norms and requirements are adhered to, the FDA inspects all manufacturing facilities as well.

Every manufacturer is responsible for abiding by all the regulatory requirements for making the medical devices safe and effective, irrespective of their type and use in the industry. This FDA regulation applies to all manufacturers producing the finished medical device and supplying the devices within an intention to commercially distribute them in the United States. A finished device is an equipment that is suitable for use, irrespective of whether or not they are labelled, packaged, or even sterilized.

FDA has established a uniform Quality System Requirement framework for quality compliance requirements in the US. The compliance audit conducted by the FDA will tell manufacturers whether the system established is compliant with current regulations. However, they will not provide any insight into how to make the products compliant or rather improve the device or the system, or the development process. But, given below are some frameworks provided by the FDA pertaining to the Quality System Requirements that could help manufacturers plan and improve their system.

Quality System Requirements to be adhered to as per the US Code of Federal Regulations

As stated before, adhering to Quality System Requirements is a necessity for any manufacturers supplying medical device with an effort to commercialize it. For medical device manufacturers seeking regulatory clearance or approval in the US need to comply with 21 CFR Part 820 of the US Code of Federal Regulations to bring their products to market. Currently, the Quality system requirements of 21 CFR Part 820 explains that the manufacturers need to comply with regulations in the following areas namely:

Management responsibilities

Internal quality audits

Personnel qualification and training

Design controls

Document and purchasing controls

Identification and traceability

Production and process controls

Process validation

Acceptance Activity

Non-Conformance of Product

Corrective And Preventive Action(CAPA)

Labelling and Packaging

Servicing

Statistical Techniques

These are the areas that are covered in the FDA’s QSR compliance which needs to be adhered to by every manufacturer seeking approval or clearance. FDA’s QSR quality system implementation and compliance process typically consist of five phases. Given below is the elaborate description of each of the Phase and its process.

Phase I: GAP Analysis

First and foremost, the manufacturing company needs to conduct a thorough GAP Analysis of the existing quality assurance process to understand the current level of compliance. This shall help determine the strengths and weaknesses of the firm and also highlight the scope of improvement required for attaining clearance and approval. With this, the management will have the information required to make an informed assessment of the time and resources they would require to attain certification or be compliant with the industry norms.

Phase II: Planning

Conducting GAP analysis will help in developing a plan of action for proceeding with certification and compliance. The management can decide and make informed decisions on diverting resources and improving the quality of products. Thereafter, the management can fix certain schedules for FDA cGMP implementation and conduct training programs across different divisions and department of the firm to create awareness and ensure buy-in from all employees.

Phases III: Documentation Development Implementation and monitoring

Phases III involves all the documentation, developmental and Implementational process. During this phase of FDA’s QSR implementation, the management can set the industry standard quality policy and objectives that shall define the quality parameters for the medical devices. Once the objectives and policies are set, the management can print out the quality system procedures, quality manual and other documentation laying out the process of product control, design, and development. You would need to prepare your documentation and develop records in compliance to 21 CFR Part 820 set by the FDA.

Phase IV: Implementational visits

Once the objectives, quality policies and frameworks are set, the management must appoint representatives, establish appropriate responsibility and authority and provide adequate resources to implement the designed plan of action as per the set policy. Not just that the management must ensure that there are regular implementation visits conducted by their internally appointed authorities to ensure that the quality system is implemented as planned.

Phases V: Internal audits and regular monitoring

The finally, Phases V of the FDA QSR quality system implementation process involves conducting an Internal audit of the process. Basically, internal audits are conducted to ensure and assess the readiness of the firms FDA’s QSR. Regular monitoring of the system process helps identify the GAP and address the deficiencies based on the findings established through the audits. This will ensure that the medical products manufactured are fully compliant as per the set FDA norms and regulations.

Implementation Timelines for FDA QSR quality systems

Normally the timelines for implementation of FDA’s QSR quality systems depends on the size and complexity of a given manufacturing operation. Firms having less than 50 employees and a single manufacturing facility, the quality system implementations could probably take about three to six months approximately. However, for medical device manufacturing firms having more than 50 employees in addition to having multiple manufacturing facilities, it would probably take around five to nine months approximately to complete the entire implementation process.

Quality inspection

Manufacturers supplying medical devices to the U.S. are subject to a strict inspection of their Quality Management Systems in order to be compliant with the requirements of 21 CFR 820. FDA’s regulatory approach to ensure compliance by all the medical device manufacturers of the industry includes a series of assessment and enforcement actions. So, as per rules, it takes nearly four working days which includes management, development, corrective and preventive action, as well as complete production and process control inspection. Manufacturers can apply for participation in the Food and Drug Administration’s (FDA) Accredited Persons (AP) program. Thereafter the manufacturers will be notified by the FDA about the inspection of their facility’s quality management system, after which they are required to apply with the FDA. If the FDA agrees to have the inspection done by the Accredited Persons, then the last date of inspection can also be fixed with the FDA.

Operon Strategist assists companies and medical device manufacturers by providing consultancy services, We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210 and 211), Device (FDA 21 CFR part 820) and Combination Products (21 CFR Part 4).