Contains Nonbinding Recommendations Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised) Guidance for Industry and Food and Drug Administration Staff November 2020 This document supersedes “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency” issued June 19, 2020. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (CDRH) Office of Strategic Partnerships and Technology Innovation (OST) Contains Nonbinding Recommendations Preface Public Comment This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket number FDA-2020-D-1138 and complete title of the guidance in the request. Additional Copies Additional copies are available from the FDA webpage titled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders ,” available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related- guidance-documents-industry-fda-staff-and-other-stakeholders, and the FDA webpage titled “Search for FDA Guidance Documents,” available at https://www.fda.gov/regulatory- information/search-fda-guidance-documents. You may also send an e-mail request to CDRH- Guidance@fda.hhs.gov to receive an additional copy of the guidance. Please include the document number 20032-R2 and complete title of the guidance in the request. Questions For questions about this document, contact CDRHManufacturerShortage@fda.hhs.gov. ii Contains Nonbinding Recommendations Table of Contents I. Introduction ................................................................................................................................. 1 II. Background ................................................................................................................................. 2 III. Policy for Notifying CDRH of an Interruption or Permanent Discontinuance in Manufacturing ..................................................................................................................................................... 3 A. Who Must Notify ................................................................................................................. 3 B. When To Notify ................................................................................................................... 5 C. What Information To Include in 506J Notifications ............................................................ 6 D. How To Notify ..................................................................................................................... 7 E. Failure to Notify ................................................................................................................... 7 IV. FDA’s Determination That a Device Is In Shortage ................................................................... 8 A. How FDA Determines What Devices Are In Shortage........................................................ 8 B. FDA’s List of Devices Determined to Be In Shortage......................................................... 9 C. Expedited Inspections and Reviews ..................................................................................... 9 V. Example 506J Notification.............................................................................................................. 10 iii Contains Nonbinding Recommendations Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356j), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency. 1 Section 506J of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. 2 This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate 1 This guidance applies only to devices regulated by the Center for Devices and Radiological Health (CDRH). 2 See section 506J(a) of the FD&C Act. 1 Contains Nonbinding Recommendations shortages of such devices during the COVID-19 public health emergency. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. II. Background There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, HHS issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. 3 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. 4 On March 27, 2020, the CARES Act was signed into law. Section 3121 of the CARES Act amends the FD&C Act by adding section 506J to the statute. Section 506J provides the Secretary with new authorities intended to help prevent or mitigate medical device shortages 5 “during, or in advance of, a public health emergency declared by the Secretary under section 319 of the PHS Act.” 6 3 Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists (originally issued on Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. 4 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national- emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. 5 “Shortage” is defined as “a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.” See section 506J(i)(2) of the FD&C Act. 6 See section 506J(a) of the FD&C Act. 2 Contains Nonbinding Recommendations Under 506J(a) of the FD&C Act, manufacturers of certain devices, 7 as described in more detail in Section III of this guidance, are required to “notify the Secretary…of a permanent discontinuance in the manufacture of the device…or an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States” during a declared public health emergency. 8 If a person fails to submit the information required under section 506J(a) in accordance with the timing set forth in section 506J(b) of the FD&C Act, section 506J(e) of the FD&C Act requires that the Secretary shall issue a letter informing them of such failure. 9 In addition, under section 506J(f) of the FD&C Act, if the Secretary concludes, that there is, or is likely to be, a shortage of a device, inspections, as well as review of submissions, may be prioritized and expedited to help mitigate or prevent shortages. Section 506J(g) of the FD&C Act also requires the Secretary to establish and maintain a publicly-available, up to date list of the device that have determined to be in shortage. FDA is issuing this guidance to clarify and make recommendations regarding who must notify FDA, what information to include in the notification, and how to notify FDA, for the duration of the COVID-19 public health emergency. 10 On June 19, 2020, FDA revised this guidance to announce the availability, on FDA’s website, 11 of a table of device types that FDA recommends manufacturers consider in determining whether a notification under section 506J of the FD&C Act (hereafter referred to as a “506J notification”) is required during the COVID-19 pandemic. This update includes information about failure to submit notifications as required under section 506J(e) of the FD&C Act, as well as a discussion of factors FDA considers in determining whether a device is in shortage, FDA’s public list of devices determined to be in shortage per section 506J(g) of the FD&C Act, and information regarding expedited inspections and reviews per section 506J(f) of the FD&C Act. This update also revises the recommended timeline for updates to 506J notifications. III. Policy for Notifying CDRH of an Interruption or Permanent Discontinuance in Manufacturing A. Who Must Notify Under section 506J of the FD&C Act, manufacturers of the following devices must submit notifications of an interruption or permanent discontinuance in manufacturing: 7 See section 506J(a) and (b) of the FD&C Act. 8 See section 506J(a) of the FD&C Act. 9 See section 506J(d) of the FD&C Act. 10 This guidance applies to reporting under section 506J of the FD&C Act during the COVID-19 public health emergency. Implementation of section 506J of the FD&C Act is ongoing, and the Agency intends to provide more details regarding implementation when they are available. 11 See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-device-types-help- determine-section-506j-notification-obligations 3 Contains Nonbinding Recommendations • Devices that are critical to public health during a public health emergency, including those that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery; 12 or • Devices for which FDA determines information on potential meaningful supply disruptions is needed during a public health emergency. 13 For purposes of this guidance, FDA interprets the term “manufacturer” to mean the entity that holds the medical device marketing submission authorization, or, if a medical device marketing submission is not required, the entity responsible for listing the medical device under section 510(j) of the FD&C Act. If a manufacturer makes a device described in section 506J(a)(1) – (2) that has marketing authorization from FDA, or is listed under section 510(j) of the FD&C Act, that device is subject to a 506J notification. For example, manufacturers of ventilators or thermometers that have received 510(k) clearance, or of surgical gowns listed pursuant to section 510(j) of the FD&C Act are subject to the notification requirement in section 506J. Manufacturers of devices, such as ventilators or thermometers that are required to submit a premarket notification under section 510(k) of the FD&C Act to FDA and obtain FDA clearance prior to marketing the devices in the United States, but have not received such clearance and are distributing the device in light of an FDA guidance on enforcement discretion during the COVID-19 public health emergency, are not subject to the notification requirements of section 506J. 14 Under section 506J of the FD&C Act, manufacturers of devices that are critical to public health during a public health emergency, or for which FDA determines information on potential meaningful supply disruptions is needed during a public health emergency, are required to notify FDA of an interruption or permanent discontinuance in manufacturing of such devices. FDA recommends that manufacturers evaluate the following circumstances when determining whether they are required to notify FDA: • Whether the device (with or without accessories) is life-supporting, life-sustaining, or intended for use in emergency medical care (examples could include ventilator and ventilator tubing, hemodialysis equipment, automated external defibrillator); • Whether the device (with or without accessories) is intended for use during surgery (examples could include cardiopulmonary bypass oxygenators, infusion pumps and tubing); • Whether the device (with or without accessories and/or testing supplies) is used to diagnose, cure, treat, mitigate or prevent COVID-19 (examples could include specific supplies from diagnostic and serological specimen collection kits, reagents for extraction or PCR amplification or serological testing, pulse oximeters, cardiac and other monitoring equipment); or • Whether the device (with or without accessories) would be in higher-than-typical demand during the response to COVID-19 pandemic compared to a similar period of time (examples could include personal protective equipment). 12 See section 506J(a)(1) of the FD&C Act. 13 See section 506J(a)(2) of the FD&C Act. 14 During the COVID-19 public health emergency, FDA has issued a number of guidances where it has stated that it does not intend to object to modifications to FDA-cleared devices, or to the distribution and use of new devices, without prior submission of a premarket notification pursuant to section 510(k) of the FD&C Act. See https://www.fda.gov/emergency- preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders. 4 Contains Nonbinding Recommendations FDA’s website 15 also contains a table of device types and corresponding product codes that FDA recommends manufacturers consider in determining whether they are required to notify FDA during the COVID-19 pandemic. This table represents FDA’s current understanding of the circumstances described above. This table is not exhaustive, and FDA intends to update it as the COVID-19 pandemic evolves. If a device type is not included on this table, but you believe it requires a 506J notification, or if you have questions regarding the device types on this table, you should contact FDA at CDRHManufacturerShortage@fda.hhs.gov and include “Question” in the subject line of the email. If a manufacturer is not certain whether to notify FDA about a particular device, we recommend the manufacturer contact the Agency at CDRHManufacturerShortage@fda.hhs.gov. B. When To Notify Manufacturers must submit a notification at least six months in advance of a permanent discontinuance 16 in manufacturing of a device or an interruption in manufacturing of a device that is likely to lead to a meaningful disruption in supply of the device in the United States. 17 If that timeframe is not possible, notification should be done “as soon as is practicable.” 18 For purposes of this guidance, FDA considers “as soon as practicable” to mean that a manufacturer should notify FDA no later than 7 calendar days after the discontinuance or interruption in manufacturing occurs. With sufficient notice, FDA can work with the manufacturer and other stakeholders to potentially prevent and mitigate shortages, helping prevent negative impacts to patients and healthcare personnel. The term “meaningful disruption” is defined in section 506J(i)(1)(A) of the FD&C Act as “a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product.” For purposes of this guidance, we interpret this to mean that a manufacturer should base its reporting on its own capacity, supply, and orders, and should not consider other manufacturers’ or competitors’ capacities or assumed capacities, or what it understands about market demand for the device. Section 506J(i)(1) of the FD&C Act also provides that the term “meaningful disruption” does not include: • “[I]nterruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing, so long as the manufacturer expects to resume operations in a short period of time, not to exceed six months;” 19 15 See https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-types-help- determine-section-506j-notification-obligations 16 FDA interprets a “permanent discontinuance” to be a decision by the manufacturer to cease manufacturing and distributing a product indefinitely for business or other reasons. All such discontinuances are required to be reported within the timeframe prescribed by section 506J(b) of the FD&C Act. 17 See section 506J(b)(1) of the FD&C Act. 18 See section 506J(b)(2) of the FD&C Act. 19 See section 506J(i)(1)(B) of the FD&C Act. 5 Contains Nonbinding Recommendations • “[I]nterruptions in manufacturing of components or raw materials, so long as such interruptions do not result in a shortage of the device, and the manufacturer expects to resume operations in a reasonable period of time.” 20 For purposes of this guidance, FDA believes a “reasonable period of time” would not exceed one month. • “[I]nterruptions in manufacturing that do not lead to a reduction in procedures or diagnostic tests associated with a medical device designed to perform more than one procedure or diagnostic test.” 21 For devices designed to perform more than one procedure or diagnostic or serological test, manufacturers should provide notification of any interruption that could lead to reduction in any of the procedures or testing capabilities. For example, if a device can be used for five types of procedures, and the manufacturing interruption means only four types of procedures can be performed, this should be reported to FDA. The COVID-19 pandemic triggered unprecedented increased demand for some medical devices, as well as significant disruptions to global medical device manufacturing and supply chain operations. For purposes of this guidance, FDA interprets “interruptions in manufacturing” to include those that occur as a result of a decrease in manufacturing capability or increased demand. After the initial 506J notification of an interruption in manufacturing, FDA recommends that manufacturers provide updates every six weeks on the situation, including the expected timeline for recovery, even if the status remains unchanged. These updates are important to ensure that FDA can act on the most current information. We recommend such updates be submitted until the shortage risk has been resolved. FDA may contact manufacturers that have not submitted updates within six weeks of their 506J notification or their latest update (as applicable) and request that the manufacturer provide the most current information on the situation. If a manufacturer is considering taking an action that may lead to a meaningful disruption in the supply of a device (e.g., holding production to investigate a quality issue or transfer of ownership), FDA requests that the manufacturer notify FDA immediately through the process explained in Section III.D. of this guidance. In addition, if a manufacturer is ordered by another United States government entity to take an action that diverts supply from the originally intended customer, FDA requests that the manufacturer notify FDA using the process explained in Section III.D. of this guidance. If a manufacturer is not certain whether to notify FDA, we recommend the manufacturer contact the Agency at CDRHManufacturerShortage@fda.hhs.gov. C. What Information To Include in 506J Notifications Per section 506J(a) of the FD&C Act, 22 manufacturers of the devices identified in Section III.A. of this guidance must submit notifications of: • “a permanent discontinuance in the manufacture of the device (except for discontinuances as a result of an approved modification of the device);” or • “an interruption of the manufacture of the device that is likely to lead to a meaningful 20 See section 506J(i)(1)(C) of the FD&C Act. 21 See section 506J(i)(1)(D) of the FD&C Act. 22 See section 506J(a) of the FD&C Act. 6 Contains Nonbinding Recommendations disruption in the supply of that device in the United States;” and • “the reasons for such discontinuance or interruption.” When providing a 506J notification, in addition to the information described in 506J(a) of the FD&C Act, the manufacturer should also provide FDA with appropriate identifying information, such as marketing submission holder name, marketing submission number (if applicable), manufacturer name (if manufacturer different from marketing submission holder), FDA Establishment Identifier (FEI) number, device name, product code, and contact information. Having this information enables FDA to appropriately identify the specific device for which the 506J notification has been submitted. In addition, FDA recommends that manufacturers submit other information, as outlined in Section V of this guidance, that enables us to work more effectively with other manufacturers and entities to prevent or limit any negative impact on patients or healthcare providers during the COVID-19 public health emergency. Section V of this guidance provides an example of the information that FDA recommends be included in a 506J notification and examples of reasons for the discontinuance or interruption, as well as the other voluntary information described above. It is important to note that manufacturers need not have all of the information before submitting a 506J notification; 506J notifications can be updated at any time to include additional information. Therefore, we recommend that manufacturers not delay notifying the Agency until all information is available, but instead recommend that they provide initial 506J notification as soon as is practicable and additional information as it becomes available. Any information provided to FDA that is trade secret or confidential information will be treated as such, consistent with section 552(b)(4) of title 5, United States Code, section 1905 of title 18, United States Code, and other applicable laws. 23 D. How To Notify If you have questions about submitting a 506J notification, we recommend that you either consult FDA’s website 24 or contact the Agency at CDRHManufacturerShortage@fda.hhs.gov and include “Question” in the subject line of the email. E. Failure to Notify If a manufacturer fails to provide notification of a permanent discontinuance or an interruption in manufacturing as required by section 506J(a) of the FD&C Act and in accordance with the timelines set forth in section 506J(b) of the FD&C Act, FDA will issue a letter to that manufacturer informing the manufacturer of such failure. 25 The manufacturer must respond to FDA’s letter not later than 30 calendar days after issuance of FDA’s letter, setting forth the basis for noncompliance and providing the required information on the discontinuance or interruption per 506J(a) of the FD&C Act. 26 Not 23 See section 506J(d) of the FD&C Act. 24 See https://www.fda.gov/medical-devices/medical-device-safety/contact-fda-about-medical-device-supply-chain-issue 25 Section 506J(e)(1) of the FD&C Act. 26 Section 506J(e)(2) of the FD&C Act. 7 Contains Nonbinding Recommendations later than 45 calendar days of issuance of the letter to the manufacturer, FDA will make that letter and any response received available to the public on FDA’s website with appropriate redactions to protect trade secrets or confidential commercial information. 27 However, FDA will not post the letter and response if the Agency determines that the letter was issued in error or, after review of the manufacturer’s response, that the manufacturer had a reasonable basis for not notifying FDA as required. 28 IV. FDA’s Determination That a Device Is In Shortage In determining whether a medical device is in shortage, FDA considers factors such as the relevant information and data available to the Agency, including indications of supply disruptions through 506J notifications and voluntary manufacturer notifications. The analysis of information related to potential device shortages informs FDA work related to other measures FDA uses to help address the public health emergency, including issuance of EUAs for products that play an important role in meeting demand. Certain products currently available in the United States during the COVID-19 public health emergency are only available under an EUA, which requires, among other things, that there be no adequate, approved, and available alternatives. 29 The analysis of information related to potential device shortages also informs FDA’s consideration of additional mechanisms for addressing device supply availability, including use of enforcement discretion, expediting inspections or premarket reviews, and working with other federal partners. A. How FDA Determines What Devices Are In Shortage FDA carefully reviews each 506J notification it receives, and uses this information, along with additional information on the supply and demand of the device, to determine whether a device is in shortage. The other information FDA reviews in making shortage determinations includes, but is not limited to: • indications of supply disruptions (e.g., 506J notifications and voluntary manufacturer information); • indications of distribution pressures (e.g., from distributors and group purchasing organizations); • indications of demand or projected demand, such as availability issues reported from users (e.g., patients, healthcare providers, hospitals, nursing homes, and associations representing these groups); • international factors (e.g., export restriction); and • certain actions taken to 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, FDA considers the entirety of relevant and reliable information and data available to the Agency at the time of a decision. 27 Section 506J(e)(3) of the FD&C Act. 28 Section 506J(e)(3) of the FD&C Act. 29 See section 564(c) of the FD&C Act. 8 Contains Nonbinding Recommendations B. FDA’s List of Devices Determined to Be In Shortage Section 506J(g) of the FD&C Act requires the establishment and maintenance of an up-to-date list of medical devices that have been determined to be in shortage. This list also identifies medical devices for which there has been notification that manufacturing has been permanently discontinued (“a discontinuance”). FDA’s website 30 contains a list that fulfills this statutory obligation and reflects the categories of devices the FDA has determined to be in shortage at this time, and the list will be maintained and updated as the COVID-19 public health emergency evolves. The FDA publishes this device shortages list to provide transparency to the American public, particularly those who use and/or purchase medical devices. As outlined by Section 506J(g)(2) of the FD&C Act, this list includes the category or name of the device in shortage, the name of each manufacturer, and the reason for the shortage, and the estimated shortage duration. The basis for the interruption identified on the list is determined by FDA considering the following factors and categories, with additional clarifications from FDA in parenthesis: • Requirements related to complying with good manufacturing practices (see section 506J(g)(2)(C)(i)); • Regulatory delay (see section 506J(g)(2)(C)(ii)); • Shortage or discontinuance of a component, part or accessory of the device (see section 506J(g)(2)(C)(iii)) (including specific supplies from diagnostic and serological specimen collection kits or reagents for extraction or PCR amplification or serological testing); • Discontinuance of the manufacture of the device (see section 506J(g)(2)(C)(iv)); • Delay in shipping of the device (see section 506J(g)(2)(C)(v))(e.g., due to export or import challenges, or transportation challenges); • Delay in sterilization of the device (see section 506J(g)(2)(C)(vi)); • Increase in demand for the device (see section 506J(g)(2)(C)(vii)); and/or • Facility closure (see section 506J(g)(2)(C)(viii)). As appropriate, FDA intends to work with manufacturers to ensure the accuracy and appropriateness of information before posting publicly on its website. FDA may elect not to make information collected under section 506J publicly available if the Agency determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of the device to patients). 31 C. Expedited Inspections and Reviews If FDA concludes, based on 506J notifications and/or any other relevant information, that there is, or is likely to be, a shortage of a device, the Agency will, as appropriate: • “prioritize and expedite the review of a submission under section 513(f)(2), 515, review 30 See https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during- covid-19-public-health-emergency 31 Section 506J(g)(3)(C) of the FD&C Act. 9 Contains Nonbinding Recommendations notification under section 510(k), or 520(m) for a device that could help mitigate or prevent such shortage; or” • “prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent such shortage.” 32 FDA continues to complete prioritized, on-site surveillance inspections for domestic firms. During the COVID-19 public health emergency, FDA intends to prioritize the types of inspections that can safely occur within a region. When prioritizing such work, FDA considers 506J notifications as well as other information related to potential device shortages. In addition to the authority under 506J(f) of the FD&C Act, FDA is committed to providing timely access to critical devices to address the COVID-19 pandemic, including through issuance of EUAs. FDA considers several factors in prioritizing the review of EUA requests, including the availability of the product, such as 506J notifications and other information related to potential device shortages. 33 V. Example 506J Notification Note: This example is intended to illustrate the type of information that FDA recommends be included in a notification pursuant to section 506J of the FD&C Act. Section 1: Type of 506J notification  Initial 506J notification  Update to previous 506J notification Section 2: Identifier information • Are you submitting on behalf of another party? • Submitter’s contact information (First Name, Last Name, Email Address, Phone) • Marketing submission holder • Marketing submission number (as applicable) • Manufacturer name (if different from marketing submission holder) • FDA Establishment Identification (FEI) number(s) (where device is manufactured) • Generic device name • Product code • Device trade name • UDI number  Yes; UDI numbers provided below UDI number(s) 32 Section 506J(f) of the FD&C Act. 33 See FDA’s guidance “Emergency Use Authorization of Medical Products and Related Authorities” https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical- products-and-related-authorities. 10 Contains Nonbinding Recommendations  No; model or catalog number(s) provided below Model or catalog number(s) • Contact name • Contact email and phone number Section 3: Reason(s) for the discontinuance or interruption (more than one may apply)  Requirements related to complying with good manufacturing practices  Regulatory delay  Order to divert devices from other U.S. government entities  Shortage or discontinuance of a component, part or accessory of the device (including specific supplies from diagnostic and serological specimen collection kits or reagents for extraction or PCR amplification or serological testing)  Discontinuance of the manufacture of the device  Delay in shipping of the device (e.g., due to export or import challenges, or transportation challenges)  Delay in sterilization of the device  Increase in demand for the device  Facility closure  Device is currently in shortage (i.e., demand currently exceeds supply)  Device is expected to be in shortage (i.e., projected demand exceeds projected supply)  Device on backorder (i.e., temporarily out of stock)  Device on allocation (i.e., limiting the quantity distributed to customers to extend the life of the existing supply)  Device on export restriction  Longer than usual delay from order to delivery  Other reasons not listed above; description below. Description of reason(s) for the discontinuance or interruption. Section 4: Duration of discontinuance or interruption Estimated timeframe (i.e., dates) and/or duration (i.e., number of days) of the discontinuance or interruption. 11 Contains Nonbinding Recommendations In addition to the information in Sections 1-4, it would be helpful to FDA, during the COVID-19 public health emergency, to receive the following information to help enable FDA to better manage any potential shortages or meaningful disruptions to the device supply chain. Section 5: COVID-19 pandemic-specific inquiries • Has the COVID-19 pandemic further affected your ability to manufacture or distribute your device(s)?  No  Yes; issue(s) described below  Labor shortages  Lack of protective equipment for employees  Shortage or delay in raw material supply  Temporary plant closure  Shipping/transportation challenges  Export/import challenges  Other Additional details of issue(s). • Do you rely on any critical suppliers that might be affected by the COVID-19 pandemic?  No  Yes; impact and supplier(s) below. Description of how reliance on critical suppliers affected by the COVID-19 pandemic might adversely impact your ability to manufacture device(s). (If you are willing/able), names of your critical supplier(s). Section 6: Additional information, including possible mitigations • Is this device manufactured on multiple lines?  No  Yes • Is this device manufactured in multiple facilities?  No  Yes 12 Contains Nonbinding Recommendations • How much device inventory do you have? Current device inventory. • Have you provided, or will you provide, public information for your stakeholders and patients regarding this actual or potential shortage (e.g., Dear Healthcare Provider (DHCP) Letters, supply or shortage information posted on your website)?  No  Yes • Do you have a proposal for FDA to review to expedite availability of your device? What else do you think FDA can do to help prevent or mitigate a supply disruption?  No  Yes Proposal to expedite availability of device and/or for FDA to help prevent or mitigate a supply disruption. • Do you have shortage mitigation plans in place that could be shared with FDA?  No  Yes; description below Describe shortage mitigation plans or provide a copy as an attachment. Section 7: Production Capacity & Market Share (for this FEI and product code) Device descriptor Estimated Avg Historic Avg Historic Current Prod Current US Max US market Production US Volume distribution Production share (%) Volume distribution [# / mo] [# / mo] Volume [# / mo] [# / mo] [# / mo] e.g., e.g., 10% e.g., 300 e.g., 250 e.g., 100 e.g., 100 e.g., 500 GenericDevice 13