The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical device regulation, announced amendments to the MDDT framework.
Medical Device Development Tools (MDDT)
The Agency published a notice dedicated to certain amendments made to the regulations on the Medical Device Development Tools (MDDR) program – a special approach used to assess tools used by medical device manufacturers in the course of the development process. To describe this assessment procedure, the FDA uses the term “Qualification” as the evaluation process based on evidence confirming that the tool in question is suitable for its intended purpose. In accordance with the FDA guidance, the tool should be evaluated in the specific context it is intended to be used in, depending on the following factors:
- the product area,
- the role that the tool subject to the evaluation should play in the development process,
- the particular phases of the development process requiring the tool to be used, and
- the output from the tool.
According to the official FDA guidance, the MDDT could be defined as “a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device.” A scientifically validated MDDT could be used in the medical device evaluation process for the purpose of providing information required in the course of regulatory procedures related to placing the medical device on the US market.
The Medical Device Development Tools program is intended to encourage the use of innovative technologies and novel approaches to medical device development and create a favorable regulatory framework in order to expand the availability of entirely new medical devices to the patients. The program also allows improvements to the overall effectiveness of the regulatory procedures applied when performing the assessment of a medical device subject to review. Thus, it also improves the quality of medical devices allowed to be marketed in the US. The authority also stated that the implementation of the MDDT program creates a favorable regulatory framework for scientific research and development.
The MDDT program could be applied for medical devices regulated by the Center for Devices and Radiological Health (CDRH).
The guidelines published by the FDA also describe special categories applicable to the tools falling within the scope of the program. According to the information published by the Agency, the following categories should be applied:
- Clinical outcome assessment – tools intended to measure the feelings of the patient and the way his organism operates. This category includes various scales used to measure reported outcomes.
- Biomarker tests – special laboratory tests intended to identify biologic processes or pharmacological responses.
- Nonclinical assessment model – bench model used to predict the way the medical device would impact the patient’s organism. This category also includes computer modeling.
Participation in the MDDT Program
There are three ways the qualification process could be initiated:
- In case when the authority itself identifies a particular area where additional tools are required.
- In case when such needs are being identified by stakeholders (various industry representatives).
- When the developer of the medical device development tool applies for qualification in order to be allowed to extend the scope of application of the aforementioned tool.
Several tools could be created to meet the same need. The authority explicitly states that the fact that there is an alternative tool already available on the market should not prevent the developers from creating a new one.
The Agency also provides information regarding the way the medical device manufacturer could participate in the MDDT Program. At the moment, participation in the Medical Device Development Tools program is voluntary.
According to FDA guidance, the program is intended to improve all processes related to the development, evaluation of tools used to measure the effectiveness and performance of medical devices. It is also important to mention that there is no fee to be paid when applying for qualification.
In order to apply for the MDDT program, the medical device manufacturer or developer of the tools shall submit the appropriate application in the electronic form using media carrier. Such a carrier should be physically sent to the Document Mail Center using the postal address indicated in the FDA guidance.
Qualification Process in Detail
In accordance with the official guidelines, the whole qualification process includes several steps to be performed.
- Proposal phase – determination of whether the particular tool in question is eligible to be subject to qualification under the program. This stage includes the submission of a set of documents describing the Medical Device Development Tool in detail. It is also important to provide explanations describing the way the use of the tool would help to improve the medical device development process.
- Incubator phase. In case if the authority will find the tool subject to review as important for public health protection, it could accept the application even if the tool requires additional development before being used for the intended purpose. This phase is optional and is intended to assist medical device manufacturers in developing tools vitally important for the industry.
- Pre-Qualification. The authority will provide the applicant (medical device manufacturer or developer of the tool) with the feedback regarding the submission. In particular, the feedback should cover aspects related to the collection of evidence justifying the importance and effectiveness of the tool.
- Qualification phase – the process of assessment of the medical device development tool.
- Qualification decision – the authority will issue its final decision based on the following key points:
- The description of the tool provided to the authority.
- The intended context of use.
- The potential impact the tool could have on public health.
- The sufficiency of the evidence provided by the applicant.
- The rigorous analysis and assessment of both advantages and disadvantages of the medical device development tool subject to review.
In case if the medical device development tool obtains approval from the authority (qualification), it is allowed to be used by various medical device developers.
The authority explicitly encourages the developers of the MDDT to make their product publicly available in order to allow manufacturers to use the newest tools to measure and evaluate the performance of devices they design and develop.
In the present notice published by the FDA, the Agency informs about the first tools qualified under the MDDT program. In particular, the document contains a list of six tools approved to be used in the US by medical device manufacturers.
Summarizing the information provided here above, the FDA has implemented a special framework dedicated to medical device development tools intended to be used to evaluate the effectiveness of medical devices during the examination stages.
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