Regulation

Molecular imaging often involves preclinical and clinical studies. As a consquence, there are several possible regulations which govern such work. In this page we attempt to provide a high-level overview of some of the concepts involved in regulating molecular imaging.

DISCLAIMER

Nothing on this page consistutes legal advice, and no action should be taken based on the content found here without first consulting relevant experts. This content is meant to be used solely for educational purposes but is not a substitute for qualified instruction. Use at your own risk.

High-level overview

Broadly speaking, there are a few categories of work which are regulated in many countries:

• Medical devices
• Medicinal products (drugs)
• Animal studies
• Human clinical studies
• Laboratory tests

There will generally be a relevant local, state, federal, or international authority in charge of establishing regulations and either performing or outsourcing the compliance process.

As part of the regulatory process, there are general guidelines that you are expected to follow. These are typically known as some form of "Good X Practice", such as:

• Good manufacturing practice
• Good clinical practice
• Good laboratory practice

These typically will resolve down to a set of guidelines regarding expectations for quality management, risk assessment, and other engineering practices. It is common for legislation to prescribe a need to follow relevant GxP and what properties a compliant system should have, but not to describe exactly what such a system will look like. This gives you flexibility in designing the exact processes and infrastructure that you will need.

Traceability is a common concept found in many regulations. The general concept here is that a product in the field should be connected to the process used to produce it, including design requirements, vendor management, manufacturing process, shipment, storage, calibration, testing, and so on. In practice this typically means that each product in the field carries a reference number and a lot or serial number, which the vendor can use to identify the relevant records. This enables effective recalls, safety notices, and other processes to occur in a selective fashion, for example by recalling all food produced at a specific facility on specific dates. Without traceability, a recall may shift from a narrow scope to one involving all product at unrelated locations.

Country- and region-specific regulations and regulatory bodies

USA

The Food and Drug Administration is responsible for the ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

The Centers for Disease Control and Prevention (CDC)is responsible for establishing quality standards for laboratory tests, through CLIA.

EU

Medical devices are governed through MDR. The process of approving medical devices (issuing the CE mark) itself is performed by various Notified Bodies.

Medicinal products are governed in various forms by the EMA. Note that this is only one part of the framework, which may involve relevant state-level and other authorities.

ISO

While not strictly a regulatory body, ISO provides standards documents that are often used as part of the regulation itself, either implicitly or explicitly. A few relevant standards include:

• ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes)
• ISO 60601 (Medical electrical equipment)

Specific auditors, notified bodies, and other organizations will be certified to assess your compliance to the relevant standards.

Guidance documents

FDA publishes a variety of guidance documents on relevant topics. These documents are not legally binding but instead give significant insight into the processes that FDA follows when examining an application. If something is present in one of these documents, it is likely that FDA will ask for it in their process.

Label

When a product is marketed (intended for use or sale), it caries a label. This label is effectively a compilation of truthful statements about the product, which includes items such as:

• intended use
• instructions for use
• claims about the product's function
• known side effects
• storage conditions

In a very-abbreviated form, these set of claims are typically the legally-required minimal subset of facts that must be known about the product and stated explicitly in order to be compliant with the regulation. Everything on the label must in some form be traceable to laboratory tests, clinical trials, or other established methods. It is also a partial statement of liability by the vendor: anything on the label which is false is a problem, as is anything which should have been on the label but was omitted.

Sometimes, products may be used off-label. A vendor cannot market the product in this way, but certain professionals may choose to take on the liabilty themselves for any issues that may occur and use the product in a way which was not originally intended. This may include prescribing a drug for an indication which was not studied by the manufacturer.