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May 17, 2023
4 Min Read
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Now that the COVID-19 public health emergency has ended, manufacturers may be wondering if 506J notifications regarding medical device shortages are still required under the Federal Food, Drug, and Cosmetic (FD&C) Act.
Section 506J of the FD&C Act requires manufacturers of certain devices to notify FDA of a permanent discontinuance or an interruption in the manufacture of a device that is likely to lead to a meaningful disruption in domestic supply of the device during, or in advance of, a declared public health emergency.
The mandatory nature of 506J notifications only applies during or in advance of a declared public health emergency. So, the short answer is no, manufacturers are no longer required to submit 506J notifications. FDA does, however, encourage manufacturers to continue to notify the agency about interruptions and discontinuances on a voluntary basis, as such information will help FDA prevent and mitigate disruptions in the supply of critical medical devices.
In January 2022, FDA issued a draft guidance related to 506J notifications. This guidance, when finalized, is intended to help manufacturers in providing timely, informative notifications about changes in the production of certain medical devices to help prevent or mitigate supply shortages. The guidance is also meant to help stakeholders in the agency's implementation of section 506J of the FDA&C Act outside of the COVID-19 public health emergency. The finalized guidance would also serve as a baseline for information about 506J notifications during or in advance of future public health emergencies.
Frequently asked questions about 506J notifications
Q. How do I submit voluntary 506J notifications?
FDA has developed an online webform to assist manufacturers in submitting 506J notifications. Manufacturers may submit both initial notifications and update notifications online using the webform. Or, manufacturers may email 506J notifications to [email protected] and begin the email subject line with the word "notification."
In follow-up to a 506J notification, FDA may seek additional information, on a voluntary basis.
Other stakeholders (patients, healthcare providers, healthcare systems, distributors, group purchasing organizations) experiencing supply chain disruptions may also notify FDA directly of by emailing [email protected].
Q. Is the information I submit confidential?
A. Any information provided to FDA that is trade secret or confidential information will be treated as such, consistent with applicable laws.
Q. I realized I submitted incorrect information. How can I correct or change a notification I previously submitted?
A. Email [email protected] and describe the error included in your 506J notification.
Q. How does FDA determine what devices are in shortage?
A. "Shortage" is defined in section 506J of the FD&C Act as "a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device." The agency reviews each notification it receives, and uses this information, along with additional information on the supply of and demand for the device, to determine whether a device is in shortage. Other information FDA may consider in making shortage determinations includes, but is not limited to:
Indications of supply disruptions
Indications of distribution pressures (for example, from distributors and group purchasing organizations)
Indications of demand or projected demand, such as availability issues reported from users (for example, patients, healthcare providers, hospitals, nursing homes, and associations representing these groups)
International factors (for example, export restriction)
Certain actions taken to help prevent or mitigate shortages including, but not limited to, actions taken by manufacturers, FDA, or other stakeholders.
In determining whether a medical device is in shortage, the agency said it tries to consider the entirety of relevant and reliable information and data available it at the time of a decision. At this time, FDA's determination of whether there is adequate supply to meet demand for a specific device category does not take the quantity of supplies accrued in the Strategic National Stockpile into consideration.
Q. What is FDA doing to help medical device manufacturers with the global shortage of semiconductor chips?
A. Semiconductor chips are essential building blocks for many products, including some medical devices. FDA said it continues to work with federal partners and other stakeholders to help mitigate challenges associated with semiconductor shortages. In addition, the agency has issued guidance documents to help provide clarity when a change in a medical device might trigger the requirement that a manufacturer submit a new premarket submission to FDA, including:
If you are experiencing supply issues for a medical device related to the global semiconductor shortage, you may contact FDA about a medical device supply chain issue. This information supports the agency's shortage analysis that informs measures the FDA may be able use to help address device supply availability.
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