The article highlights the key points related to notification requirements medical device manufacturers should follow with respect to possible discontinuance or interruption in the manufacturing process.
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The Food and Drug Administration. the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to notifying about a permanent discontinuance or interruption in manufacturing of a medical device under Section 506J of the Federal Food, Drug, and Cosmetic (FD&C) Act.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers in order to ensure compliance to it.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.
In particular, the authority has issued this guidance to address the requirements of section 506J of the FD&C Act, as established by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
This guidance is crucial in the context of a public health emergency (PHE), outlining the responsibilities of manufacturers in notifying the FDA of any permanent discontinuance or significant interruption in the manufacturing of medical devices, which could potentially result in a meaningful disruption in their supply.
Role of FDA and Section 506J Requirements
According to the document, the FDA plays an essential role in protecting the United States from various threats, including emerging infectious diseases and other PHEs.
According to section 506J, manufacturers are required to notify the FDA during or in advance of a PHE about any permanent discontinuation or significant interruption in the production of certain medical devices.
This notification is important to prevent or mitigate any potential shortages of these devices. The guidance aims to assist manufacturers in providing timely and informative notifications, which are crucial for the FDA to ensure uninterrupted availability of vitally important medical devices and prevent shortages in supply.
Additionally, the guidance encourages manufacturers to voluntarily provide extra information to ensure the FDA has comprehensive details necessary for addressing potential shortages during or ahead of a PHE.
Implementation
This guidance is instrumental in aiding stakeholders to implement section 506J effectively. It establishes a baseline for 506J notifications during or before any PHE.
The FDA may, if deemed necessary, issue PHE-specific updates or guidance documents as appendices to this guidance.
These decisions are made based on specific situations and informational needs.
CARES Act and PREVENT Pandemics Act
The CARES Act, signed into law on March 27, 2020, amended the FD&C Act by introducing section 506J.
This amendment provides the FDA with new authorities to help prevent or mitigate shortages of medical devices during or in anticipation of a PHE. Further amendments came with the PREVENT Pandemics Act, signed on December 29, 2022.
This act directed the FDA to issue or revise guidance regarding section 506J requirements and to compile a list of each device product code requiring notification under section 506J.
Additionally, section 2514 of the FY 2023 Omnibus amended section 506J to include section 506J(h) for “Additional Notifications,” directing the FDA to facilitate voluntary notifications and proposing revisions to this guidance.
Notification Requirements in Detail
As further explained by the FDA, under section 506J(a), manufacturers of certain devices are obligated to inform the FDA of any permanent discontinuance or interruption in manufacturing that is likely to cause a significant disruption in the device’s supply in the United States during or before a PHE.
Manufacturers must also provide reasons for such discontinuance or interruption. Non-compliance with these requirements, such as failing to submit necessary information within the specified timing, results in the FDA issuing a letter of non-compliance to the manufacturer.
In situations where a shortage of a device is identified or anticipated, the FDA prioritizes and expedites inspections and premarket reviews to help mitigate or prevent the shortage.
Furthermore, section 506J(g) mandates the FDA to establish and maintain a current, publicly accessible list of devices determined to be in shortage.
Policy for Notifying FDA of Manufacturing Changes
The policy for notifying the FDA under section 506J requires manufacturers to submit notifications for devices critical to public health during or before a PHE.
It clarifies who is required to notify the FDA, the appropriate timing for such notifications, the expected content of these notifications, and the process for submission.
Manufacturers with questions regarding 506J notifications are encouraged to contact the FDA through specified email addresses.
Even if they have queries, manufacturers are still advised to proceed with submitting a 506J notification.
Conclusion
In summary, the present FDA’s guidance dedicated section 506J of the FD&C Act, as amended by the CARES Act and further by the PREVENT Pandemics Act, describes in detail the approach to be followed for ensuring the continuous supply of critical medical devices during public health emergencies.
By outlining the requirements for manufacturers’ notifications and offering recommendations for compliance, the FDA seeks to mitigate the impact of device shortages, ensuring that healthcare providers and patients have access to essential medical devices when needed.
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