The CDRH performs activity aimed at the consistent improvement of the medical devices regulatory framework. The Center also established the information exchange providing all stakeholders with access to accurate information regarding medical devices and safety issues associated with them. The CDRH also intends to create a clear and transparent regulatory basis to engage medical devices, manufacturers, and developers in creating novel devices and placing them on the US market.
As part of this process, the agency has created a special informational center – CDRH Learn. Using it, all parties involved get online access to the informational materials dedicated to various aspects of medical devices regulation, provided in a detailed and structured manner. The scope of the questions covered by the multimedia materials published by the CDRH covers aspects related to both pre-market and post-market regulatory procedures medical devices and radiation-emitting products are subject to under the current legislation. The main goal in creating this was to provide the community with information that would be easily accessible and helpful.
To simplify the learning process, all information is divided into several modules each covering particular questions related to the subject. At the moment, the list of the modules available includes:
- Introduction – a general overview of the regulatory approach to medical devices, including registration and listing,
- Different types of submissions: 510(k), IDE, PMA, De Novo (a special submission type used in case if the device is entirely new and has no any analogs already available on the market), other types of submissions, and the details on applicable standards and risk-based classification of medical devices.
- Postmarket Activities – a new module recently added by the agency, dedicated to quality management systems (QMS) to be employed by the manufacturer, exporting requirements, special preventive actions such as medical device recalls and also the global harmonization processes.
- Unique Device Identification (UDI) System – special elements used to identify medical devices on each step of their lifecycle before being supplied to end-users or provided to the patients.
- Speciality technical topics, including requirements for dental devices and guidelines dedicated to low-risk medical devices.
- Radiation-emitting products – special module describing the way the electronic products should be placed on the market, including certification and testing. The scope of this module covers such devices as diagnostic ultrasonic systems, X-ray imaging devices and other similar equipment.
- 510(k) third party review program – another new module recently added by the agency, addressed to third party review organizations.
- Industry basics workshops – the module covering the wide range of general questions related to medical devices, such as exemptions for custom (personalised) devices, requirements applicable to the manufacturing process, management control or validation.
Thus, the agency intends to provide the materials covering the most important issued medical device manufacturers and other parties involved in operations with medical devices could face in the course of their business activity.
510(k) Third Party Review Program
Since the US regulatory system does not provide the distribution of responsibility regarding conformity assessment and other regulatory activities, the FDA performs the whole cycle of regulatory procedures related to medical devices that creates additional burden and overloads the authority (it is important to mention that in some countries the issue is solved through delegating assessment functions to specially designated notified bodies – independent legal entities employing the appropriate professionals and thus eligible to perform assessment of certain types of medical devices in accordance with the scope of designations). To reduce the aforementioned burden, the FDA partially delegated the assessment functions in relations to the low-risk medical devices to the third party review organizations.
The Third Party Review Program constitutes a voluntary process of marketing application review that is an alternative to the initial one, providing that a third party review organization reviews the 510(k) application instead of the agency. This approach results in two important benefits:
- The agency releases its internal resources for more important activities, and
- It takes less time for the new devices to become available to the patients.
Under this approach, the agency deals mostly with complex high-risk medical devices while all the issues related to the low-risk medical devices are duly covered by the accredited third party review organizations.
Actually, the program consists of two core elements: the accreditation of the third parties eligible to assess the applications and the application review process itself. In general, the whole process could be conventionally divided into the following steps:
- Accreditation. To be eligible to review the applications, the third party organizations should be accredited by the FDA confirming that it complies with all applicable requirements and the results of the review performed by such organization would be reliable.
- Application. Since the program is voluntary, an applicant may submit the application either directly to the FDA, or to the third party organization.
- Review. The third party organization reviews the application and provides the authority with the initial submission, review details and its recommendations.
- Final decision. Upon receipt of the recommendations, the agency shall provide its final decision within 30 days.
The second new educational module added by the agency is dedicated to the post-market activities to be performed to ensure the safety and effective performance of the devices for the intended purpose as intended by the manufacturer during its whole lifecycle. In particular, the module includes the following subsections:
- Introduction to the quality system,
- Production and process controls,
- Documents, change control and records,
- Design controls,
- Management controls,
- Purchasing controls,
- Process validation,
- Corrective and preventive actions,
- Guidelines regarding nonconforming products,
- Filing complaints and other issues associated thereto.
The materials available in this module also describe the requirements related to exporting and importing medical devices, explain in detail the concept of the benefit-risk approach to the medical devices regulation, address certain issues related to medical device recalls and medical device reporting, and also give a light global harmonization processes in the sphere of inspections, providing the exhaustive information regarding the Medical Device Single Audit Program (MDSAP), the pilot project introduced by the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulating authority collaborating to improve the regulatory framework.
Summarizing the information provided above, the materials available online via the CDRH Learn educational portal could be useful for medical device manufacturers and other parties involved in operations with medical devices to maintain compliance with all applicable regulations.
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