The article provides a brief overview of the approach to be applied for medical device recalls and enhancements, including the determination of their regulatory nature and the requirements to be followed.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to distinguishing medical device recalls from medical device enhancements. The document is intended to provide additional clarifications on the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
Regulatory Background
According to the guidance, a medical device recall stands for a firm’s removal or correction of a marketed device that the Agency considers violating the laws that it administers and against which the agency would initiate legal action, e.g., seizure. The appropriate definition is provided in 21 CFR 7.3(g). The authority additionally emphasizes the existence of violation as a key element to be considered when distinguishing a medical device recall.
Since the issues associated with medical devices allowed for marketing and use in the US could result in additional risks the patients or users will be exposed to, recalls are intended to ensure public health protection by (i) communicating important safety-related information to the affected parties and (ii) making changes to the device in question to correct the defects related to the said issues to minimize the risks associated with a potential failure of the device in question. According to the applicable regulations, medical device recalls include voluntary recalls (covered by 21 CFR part 7, subpart C), either initiated by a firm on its initiative or in response to a formal request from FDA, and mandatory recalls ordered by FDA under the section 518 of the FD&C Act and 21 CFR part 810. Under the general rule, recalls of the first type are initiated and coordinated by a party responsible for a medical device. However, all the recalls are subject to classification and monitoring by the regulating authority to ensure their effectiveness.
Recalls: Key Points
As further explained by the FDA, when initiating a recall, a party responsible for a medical device placed on the market launches the appropriate mechanism intended to implement the actions necessary to ensure the public health protection and safety of patients. This includes, inter alia, making changes to the device to correct the issues identified, or removing the affected devices entirely from the market. Under the general rule, the said process is comprised of three main steps to be taken by a party responsible for the device:
- Identifying an issue related to the safety, quality, or effectiveness of a medical device that could potentially create additional risks for patients or users;
- Determining whether a recall is necessary to address an issue identified;
- Initiating a recall process following the respective procedure.
At the same time, the authority acknowledges that sometimes it could be difficult for the parties responsible for medical devices to determine whether a change to be made to the product in question actually meets the definition of a recall, the scope of the latter and whether the authority should be notified accordingly. The said difficulties faced by the authorization holders could lead to inconsistency in the interpretation of the applicable regulatory requirements, resulting in undue delays between the identification of an issue and the actual implementation of the actions required.
Furthermore, the authority acknowledges that medical device manufacturers are continuously taking steps to improve the safety, quality, and effectiveness of their products. In such cases, a new version of a medical device is created, while the previous one can still be available on the market and in use, provided it complies with any applicable regulatory requirements.
Scope of the Guidance
As further explained by the FDA, the present guidance is intended to:
- Clarify when a change to a device constitutes a medical device recall;
- Distinguishing those instances from device enchantments that do not meet the definition of a medical device recall, and
- Clarify reporting requirements under 21 CFR part 806.
The authority emphasizes that the proper categorization of changes to medical devices is vitally important to ensure the correct application of regulatory measures and controls to the changes should be subject to. Apart from clarifications on these matters, the authority highlights the key points related to enhancements for medical devices and their regulatory status.
In particular, the document outlines the main questions and provides answers thereto in a way the authority deems useful for the industry in terms of distinguishing medical device recalls from medical device enhancements.
The scope of the guidance covers any medical devices intended to be marketed and used in the US irrespective of whether they are subject to a premarket review. At the same time, the authority explicitly indicates the aspects falling outside the scope of the guidance, namely:
- Whether a new premarket submission is required;
- Radiation-emitting electronic product defects or failures to comply with radiation safety performance standards contained in 21 CFR Part 1020 to 1050; and
- Methodologies for risk management or risk assessment.
In summary, the present FDA guidance provides an overview of the approach to be applied concerning the actions to be taken in response to issues identified to ensure the public health protection and the safety of patients. The authority explains the importance of proper determination of the regulatory status of changes to medical devices depending on their nature and intended purpose.
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