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Notice

Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program

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Start Preamble

AGENCY:

Food and Drug Administration, Department of Health and Human Services (HHS).

ACTION:

Notice; request for information.

SUMMARY:

To provide Americans with expanded access to certain medical devices to respond to the COVID-19 Public Health Emergency, FDA issued guidance documents providing numerous regulatory flexibilities, including a temporary waiver of premarket notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act. For seven class I devices for which 510(k) premarket review as temporarily waived during the PHE, the Department of Health and Human Services is permanently exempting those seven (7) class I devices from the 510(k) requirement and is also proposing to exempt an additional 83 class II devices and 1 unclassified device class from the 510(k) requirement, for which premarket review had also been waived during the PHE. The Department is soliciting the public's views on whether premarket review should be permanently waived for some or all of these 83 devices and views on ways to improve the 510(k) premarket notification program.

DATES:

Part III.A of this Notice shall be effective immediately on publication in the Federal Register. To be considered, responses and comments related to Part III.B of this Notice must be received electronically, within sixty days of publication in the Federal Register as provided below. The Department will consider information submitted by the public in response to Part IV of this Notice on a rolling basis, and until further notice.

ADDRESSES:

You may submit comments through the Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted to http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov. Comments must be identified by 0991-ZA52. Because of staff and resource limitations, all comments must be submitted electronically to www.regulations.gov. Follow the “Submit a comment” instructions.

Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments may be posted on the internet and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to comments received.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including personally identifiable or confidential business information that is included in a comment. You may wish to consider limiting the amount of personal information that you provide in any voluntary public comment submission you make. HHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov. Follow the search instructions on that website to view the public comments.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Dan Barry, 200 Independence Ave. SW, Washington, DC 20201; or by email at daniel.barry@hhs.gov; or by telephone at 1-877-696-6775.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The Administration is committed to creating a data-based regulatory process that appropriately balances benefits and costs. Consistent with the President's executive order on COVID-19 regulatory flexibilities, and Congress' direction in the 21st Century Cures Act, the Department is issuing this Notice to permanently exempt or proposing to permanently exempt certain class I and class II medical devices from the premarket notification requirement in section 510(k) of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360(k). Under this notice, the Department is immediately making permanent the exemption of 7 class I device classes from the section 510(k) requirement and proposes to exempt an additional 84 class II and unclassified device classes from the same requirement on a permanent basis. These 91 devices were all subject a 510(k) waiving during the PHE.

I. Background

A. Statutory Framework

Under the Food, Drug, and Cosmetic Act (FD&C Act), medical devices are placed “in three categories based on the risk that they pose to the public.” [1] Class I devices, products “that present no unreasonable risk of illness or injury,” [2] are subject to general controls. FD&C Act 513(a)(1)(A), 21 U.S.C. Start Printed Page 4089360c(a)(1)(A). Class II devices are “potentially more harmful” than class I devices, and “must comply with federal performance regulations known as `special controls.'” [3] Class III devices carry the highest risk, in that they are for “use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present[ ] a potential unreasonable risk of illness or injury.” FD&C Act 513(a)(1)(C)(ii)(I)-(II), 21 U.S.C. 360c(a)(1)(C)(ii)(I)-(II).

Medical devices are generally subject to FDA premarket review in one of two forms. The first is premarket approval (PMA) review under section 515 of the FD&C Act, 21 U.S.C. 360e. This form of “rigorous” review, analogous to FDA review of a New Drug Application for a “new drug,” requires manufacturers to “submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews.” [4] During the mid-1990s, FDA reported spending “an average of 1,200 hours on each [PMA] submission,” [5] though the time for review has likely increased since Lohr was decided.

The second form of premarket review is the premarket notification process, which is commonly referred to as the 510(k) process after section 510(k) of the FD&C Act, 21 U.S.C. 360(k). Generally, under the 510(k) process, a device that is “substantially equivalent” to another legally marketed predicate device is “cleared” (as opposed to “approved”) [6] by FDA for legal marketing in the United States. See FD&C Act 510(k), 513(i), 21 U.S.C. 360(k), 360c(i). FDA regulations specify the required contents of 510(k) notifications, including labeling, intended use, and clinical and performance data requirements. 21 CFR 807.92. FDA previously reported requiring “an average of only 20 hours” to complete a 510(k) review,[7] which would be around 60 times less than the time required for PMA review.

Obtaining either a PMA approval or a 510(k) clearance to legally market a medical device is expensive and time-consuming. According to a 2010 survey of medical device companies, “the average total cost from concept to approval [of a PMA device] was approximately $94 million, with $75 million spent on stages linked to the FDA.” [8] For PMAs, survey respondents reported “that it actually took them an average of 54 months to work with the FDA from first communication to approval.” [9]

While 510(k) devices trod a swifter, less expensive path to market than PMA devices do, the same survey found that “the average total cost for participants to bring a low-to-moderate-risk 510(k) product from concept to clearance was approximately $31 million, with $24 million spent on FDA dependent and/or related activities.” [10] Respondents also reported “an average of 10 months from first filing to clearance” for a 510(k) device.[11] The survey authors acknowledged that respondents “were most likely those companies working on innovative, new medical technologies that required clinical data to get through the FDA rather those seeking relatively simple extensions to low-risk, ubiquitous product lines already in existence.” [12] Nevertheless, the survey found the average total cost connected to the “Process of Obtaining [a] 510(k) [clearance]” to be more than $4 million per product.[13] Even if these estimates overstate costs by a factor of ten, a firm could still spend $2.4 million “on FDA dependent and/or related activities,” to include an estimated $400,000 on the 510(k) clearance process itself. Similarly, even if the survey respondents overstated delays, and the actual time were much closer to FDA's goal date of 90 days for review, it is undisputed that the 510(k) clearance process delays a device's introduction to the market.

A 2014 report on antibacterial products produced for the Assistant Secretary for Planning and Evaluation (ASPE) contains similar findings. The report noted that, to conduct a pivotal clinical study to support a 510(k) submission for a MRSA point-of-care diagnostic, a manufacturer could expect to spend “from a low of $250,000 to as high as $4.0 million.” [14] The report estimated the cost to prepare and submit a 510(k) application “at $100,000” while acknowledging the amount “could be highly variable depending on device characteristics.” [15]

These costs are barriers to new market entrants. To the extent imposing the section 510(k) premarket notification on a device does not create corresponding safety and efficacy benefits for Americans, those barriers are unjustified. Such barriers warrant scrutiny, particularly when market incumbents have an interest in retaining them. As FDA acknowledged in a 1975 proposed rule in the analogous context of drug approvals, “the manufacturer who holds the `pioneer' NDA for a drug may well have an economic interest in retaining the new drug status of that drug” because “[a]s long as either a full or an abbreviated NDA is required, entry into the market place, and thus increased competition is impeded.” [16] FDA noted its belief “that it was not the intention of Congress that section 505 of the [FD&C Act] would be used as an economic trade barrier.” [17]

Start Printed Page 4090

Congress has taken action to ensure that the section 510(k) premarket notification process does not create undue economic barriers for new medical devices. Under the FD&C Act, the Secretary is authorized to exempt class I and II medical devices from the 510(k) requirement if the Secretary finds those devices “no longer require[ ] a report under section [510](k) to provide reasonable assurance of safety and effectiveness.” FD&C Act 510(l)(2), 510(m)(1)(A)(i), 21 U.S.C. 360(l)(2), 360(m)(1)(A)(i). Congress did this in part to “allow the Secretary to expend limited premarket review resources on potentially risky and technologically advanced devices” so that “the public continues to be adequately protected and will still benefit from the earlier availability of new products.” [18] In section 3054 of the 21st Century Cures Act, Public Law 114-255, 130 Stat. 1033, 1126-27 (Dec. 13, 2016), Congress imposed additional requirements on the Secretary to take action to affirmatively review class I and II devices to determine whether they are exempt from the 510(k) requirement. This Notice is responsive to these previous mandates.

B. Waiver of Premarket Notification Requirement During COVID-19 PHE

Beginning in March 2020, in response to the COVID-19 Public Health Emergency (PHE), FDA issued a series of guidance documents designed to provide the private sector with regulatory flexibility to meet the sudden, increased need for personal protective equipment, disinfectant products, and other devices to combat the pandemic. The table below presents the various guidance documents issued in April 2020 to assist in the response to the PHE.

Table 1—List of FDA Medical Device Enforcement Policies Responsive to PHE

Title of guidanceDate
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyApril 2020.
Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyApril 2020.
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)May 2020.
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health EmergencyMarch 2020.
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyMarch 2020.
Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyApril 2020.
Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyApril 2020.
Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyApril 2020.
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyApril 2020.
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency (Revised)March 2020 (original). June 2020 (revised). October 2020 (revised).
Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyApril 2020.
Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyApril 2020.
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyMarch 2020.

As FDA explained in its clinical thermometer guidance, FDA provided these flexibilities to “ensure the availability of equipment that might offer some benefit to health care providers and the general public during the public health emergency.” [19] To that end, among other things, FDA announced that the agency “does not intend to object to the distribution and use of clinical thermometers that are not currently 510(k) cleared.” [20] Some of the flexibilities, such as those extended to remote patient monitoring, have helped facilitate telemedicine during the PHE. FDA extended similar flexibility to additional devices in other guidance documents shown in Table 1.

II. HHS' Review of 510(k) Premarket Notification Flexibilities

On May 19, 2020, the President issued Executive Order No. 13924, instructing “[t]he heads of all agencies” to “review any regulatory standards that they have temporarily rescinded, suspended, modified, or waived during the public health emergency,” in order to “determine which, if any, would promote economic recovery if made permanent.” [21] Further, Congress already instructed the Secretary to consider whether to exempt class I and II devices from the section 510(k) requirement “at least once every 5 years.” FDCA 510(l)(2), 510(m)(1)(A), 21 U.S.C. 360(l)(2), 360(m)(1)(A).

Consistent with the President's executive order, and Congress' direction in the 21st Century Cures Act, the Department conducted a data-driven review to determine whether temporary waiver of the section 510(k) premarket notification requirement for some devices during the PHE should be made permanent. The flexibilities given by FDA during the PHE presented the Department with a unique opportunity to analyze the adverse event records of Start Printed Page 4091devices in periods of time with and without the premarket notification requirement. In view of this, the overarching question for HHS was whether premarket notification provided corresponding safety and efficacy benefits. Below the Department describes the methodology for its review and the results of the same.

A. Methodology

HHS first reviewed the thirteen FDA guidance documents listed in Table 1 to determine which device types are subject to those enforcement policies. The Department identified 221 unique device types. HHS analyzed those device types using FDA's Product Code Database [22] to determine how many of those devices require premarket review. Of those 221 device types, the Department determined that 5 require a PMA, 29 are exempt from the 510(k) requirement, 3 are marketed subject to FDA's enforcement discretion, and 184 require 510(k) clearance prior to marketing. Of the 184 devices types that would require 510(k) clearance without the guidance documents list in Table 1, 10 are class I devices, 173 are class II devices, and 1 is unclassified. These 184 devices are referred to collectively in this Notice as the “Review Devices.”

FDA maintains a publicly available adverse event reporting database called the Manufacturer and User Facility Device Experience database or MAUDE. MAUDE “houses [medical device reports or] MDRs submitted to the FDA by mandatory reports (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.” [23] Like any “passive surveillance system,” MAUDE has “limitations, including the potential submission of incomplete, inaccurate, untimely, or biased data,” which means “incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.” [24] Even with the system's limitations, MAUDE is an important source of data. FDA has previously used data from MAUDE to inform the agency's decision making.[25] Products liability plaintiffs also make use of the database.[26] As the CDRH Director previously explained to Congress, systems like MAUDE set the United States apart from jurisdictions like the European Union that “do not have publicly available centralized data base[s] for that kind of information.” [27]

In this review, the Department performed searches of the Review Devices in FDA's online searchable MAUDE database. Updated on a monthly basis, the online “searchable database data contains the last 10 year's data” of reports “on medical devices which may have malfunctioned or caused a death or serious injury.” [28] HHS entered the three-letter product code for each Review Device into the online MAUDE database. HHS then collected data on the number of reports for each Review Device from November 1, 2010 to November 30, 2020, tabulating the reports from November 1, 2010 to the beginning of the PHE, and for the time period subsequent the beginning of the PHE to November 30, 2020.

B. Results

Of the 184 Review Devices, HHS found there were 120 or more MAUDE reports for 74 devices and less than 100 MAUDE reports for the 110 other devices during the last ten years. This means roughly 60% of the Review Devices have less than 100 MAUDE reports over the last ten years. Of those 110 devices, 35 devices had no MAUDE reports from November 1, 2010 to November 30, 2020. Those 35 devices are shown in Table 2 below.

Table 2—Review Devices With Zero Adverse Event Reports in MAUDE for the Time Period November 1, 2010 to November 30, 2020

Device descriptionDevice classProduct codeSection in 21 CFR
Powder-Free Polychloroprene Patient Examination GloveIOPC880.6250
Ventilator, Continuous, Minimal Ventilatory Support, Home UseIINQY868.5895
Airway Monitoring SystemIIOQU868.5730
Impedance Measuring Device Utilizing Oscillation TechniquesIIPNV868.1840
Gauge, Pressure, Coronary, Cardiopulmonary BypassIIDXS870.4310
Valve, Pressure Relief, Cardiopulmonary BypassIIMNJ870.4400
Oximeter, Tissue Saturation, ReprocessedIINMD870.2700
Multivariate Vital Signs IndexIIPLB870.2300
Electrocardiograph Software For Over-The-Counter UseIIQDA870.2345
Sterilizer, Dry HeatIIKMH880.6870
Check Valve, Retrograde Flow (In-Line)IIMJF880.5440
Intravascular Administration Set, Automated Air Removal SystemIIOKL880.5445
Neuraxial Administration Set—Intrathecal DeliveryIIPYR880.5440
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, LiquidIIPSW892.1570
Pediatric/Child FacemaskIIOXZ878.4040
Normalizing Quantitative Electroencephalograph SoftwareIIOLU882.1400
Computerized Cognitive Assessment AidIIPKQ882.1470
Physiological Signal Based Seizure Monitoring SystemIIPOS882.1580
Computerized Behavioral Therapy Device For Psychiatric DisordersIIPWE882.5801
Monitor, Phonocardiographic, FetalIIHFP884.2640
Monitor, Cardiac, FetalIIKXN884.2600
Digital Pathology DisplayIIPZZ864.3700
Digital Pathology Image Viewing And Management SoftwareIIQKQ864.3700
Start Printed Page 4092
System, Imaging, Holography, AcousticIINCS892.1550
Lung Computed Tomography System, Computer-Aided DetectionIIOEB892.2050
Chest X-Ray Computer Aided DetectionIIOMJ892.2050
Computer-Assisted Diagnostic Software For Lesions Suspicious For CancerIIPOK892.2060
Radiological Computer-Assisted Triage And Notification SoftwareIIQAS892.2080
Radiological Computer Assisted Detection/Diagnosis Software For FractureIIQBS892.2090
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerIIQDQ892.2090
Radiological Computer-Assisted Prioritization Software For LesionsIIQFM892.2080
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software DeviceIIQHA892.1600
Automated Radiological Image Processing SoftwareIIQIH892.2050
Image Acquisition And/Or Optimization Guided By Artificial IntelligenceIIQJU892.2100
Apparatus, Vestibular AnalysisUnclassifiedLXVN/A

Another 43 devices had no reports in MAUDE following declaration of the PHE, and the waiver of the 510(k) premarket notification requirement, with anywhere from 1 to 86 reports in MAUDE prior to the PHE for those same devices. For the ten-year period spanning November 1, 2010 to November 30, 2020, there were a total of 637 reports in MAUDE associated with theses 43 devices listed in Table 3.1. This equates to about 1.5 MAUDE reports per year per device. Table 3.1 below shows each device with the corresponding number of adverse events before and after the PHE.

Table 3.1—Review Devices with Zero Adverse Events Post-PHE and 86 or Fewer Adverse Events Pre-PHE in MAUDE

Device descriptionDevice classProduct codeSection in 21 CFRMAUDE events November 1, 2010 to PHEMAUDE events Post-PHE to November 30, 2020
Patient Examination Glove, SpecialtyILZC880.6250460
Radiation Attenuating Medical GloveIOPH880.625010
Powder-Free Non-Natural Rubber Latex Surgeon's GlovesIOPA878.446010
Powder-Free Guayle Rubber Examination GloveIOIG880.625020
Latex Patient Examination GloveILYY880.6250480
Meter, Peak Flow, SpirometryIIBZH868.1860270
Monitor, Apnea, Facility UseIIFLS868.2377860
Monitor, Apnea, Home UseIINPF868.2377410
Oximeter, ReprocessedIINLF870.2700650
Stethoscope, ElectronicIIDQD870.187520
Defoamer, Cardiopulmonary BypassIIDTP870.423040
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary BypassIIJOD870.427020
Detector, Bubble, Cardiopulmonary BypassIIKRL870.4205440
Cpb Check Valve, Retrograde Flow, In-LineIIMJJ870.4400120
Sterilizer, Ethylene-Oxide GasIIFLF880.6860290
Cabinet, Ethylene-Oxide Gas AeratorIIFLI880.610020
Purifier, Air, Ultraviolet, MedicalIIFRA880.650010
Cleaner, Air, Medical RecirculatingIIFRF880.504570
Controller, Infusion, Intravascular, ElectronicIILDR880.5725270
Cleaners, Medical DevicesIIMDZ880.699250
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter PositionIIOMF880.597090
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical EmergenciesIIORW880.626010
Two Or More Sterilant SterilizerIIPJJ880.686060
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, MistIIOUJ892.157030
Gown, PatientIIFYB878.404010
Surgical Mask With Antimicrobial/Antiviral AgentIIOUK878.404010
Cerebral OximeterIIQEM870.270020
Device, Sleep AssessmentIILEL882.505040
Standard Polysomnograph With ElectroencephalographIIOLV882.140090
Source Localization Software For Electroencephalograph Or MagnetoencephalographIIOLX882.140020
Automatic Event Detection Software For Polysomnograph With ElectroencephalographIIOLZ882.140010
Amplitude-Integrated ElectroencephalographIIOMA882.140010
Start Printed Page 4093
Automatic Event Detection Software For Full-Montage ElectroencephalographIIOMB882.140040
Burst Suppression Detection Software For ElectroencephalographIIORT882.140010
Monitor, Heart Rate, Fetal, UltrasonicIIHEL884.2660120
Transducer, Ultrasonic, ObstetricIIHGL884.296060
Uterine Electromyographic MonitorIIOSP884.272030
Tonometer, Ac-PoweredIIHKX886.193010
Tonometer, ManualIIHKY886.193080
Automated Digital Image Manual Interpretation MicroscopeIIOEO864.186010
System, X-Ray, TomographicIIIZF892.1740350
Analyzer, Medical ImageIIMYN892.207010
C-Arm Fluoroscopic X-Ray SystemIIRCC892.1650730

The Department further analyzed the details of the MAUDE reports listed in Table 3.1. For the 5 class I glove devices listed, there were 98 reports. As shown in Table 3.2 below, after review of the detailed narratives for those 98 reports, they can be broken down into eight categories.

Table 3.2—MAUDE Report Breakdown for 5 Class I Devices in Table 3.1

Device description (Product Code)MAUDE report category
Rip/tear/ holeDiscolor/ debrisAllergy/skin issueNot device relatedImproper useMislabeledOdorTotal
Patient Examination Glove, Specialty (LZC)22194100046
Radiation Attenuating Medical Glove (OPH)00001001
Powder-Free Non-Natural Rubber Latex Surgeon's Gloves (OPA)00100001
Powder-Free Guayle Rubber Examination Glove (OIG)00200002
Latex Patient Examination Glove (LYY)6729401148
Total282636511198

More than half of the reports (55%) related to material flaws such as tears, discoloration, or foreign debris in the gloves. For the 36 allergic reaction reports, there was only one report connected with a hospital visit for which the patient was ultimately monitored and discharged. There are 5 MAUDE events from which the report narrative does not provide a basis to infer that the device itself caused the harm.[29] None of the 98 reports involved a death.

The 38 class II devices listed in Table 3.1 were connected to another 539 MAUDE reports. Of those reports, 322 (59.7%) involved device malfunctions, 71 (13.2%) involved injuries, 22 (4.1%) involved deaths, and 124 (23%) have the event type listed as “other” or “NA.” Table 3.3 below provides the breakdown of the 539 MAUDE reports by device type.

Table 3.3—MAUDE Report Breakdown for 38 Class II Devices in Table 3.1

Device descriptionProduct codeMAUDE report category
MalfunctionInjuryDeathOtherNATotal
Meter, Peak Flow, SpirometryBZH26100027
Monitor, Apnea, Facility UseFLS529169086
Monitor, Apnea, Home UseNPF34520041
Oximeter, ReprocessedNLF491400265
Stethoscope, ElectronicDQD100102
Defoamer, Cardiopulmonary BypassDTP310004
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary BypassJOD100102
Start Printed Page 4094
Detector, Bubble, Cardiopulmonary BypassKRL330011044
Cpb Check Valve, Retrograde Flow, In-LineMJJ11100012
Sterilizer, Ethylene-Oxide GasFLF79011229
Cabinet, Ethylene-Oxide Gas AeratorFLI020002
Purifier, Air, Ultraviolet, MedicalFRA100001
Cleaner, Air, Medical RecirculatingFRF600017
Controller, Infusion, Intravascular, ElectronicLDR27000027
Cleaners, Medical DevicesMDZ400105
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter PositionOMF320409
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical EmergenciesORW100001
Two Or More Sterilant SterilizerPJJ060006
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, MistOUJ110103
Gown, PatientFYB001001
Surgical Mask With Antimicrobial/Antiviral AgentOUK010001
Cerebral OximeterQEM110002
Device, Sleep AssessmentLEL400004
Standard Polysomnograph With ElectroencephalographOLV720009
Source Localization Software For Electroencephalograph Or MagnetoencephalographOLX110002
Automatic Event Detection Software For Polysomnograph With ElectroencephalographOLZ010001
Amplitude-Integrated ElectroencephalographOMA100001
Automatic Event Detection Software For Full-Montage ElectroencephalographOMB100124
Burst Suppression Detection Software For ElectroencephalographORT100001
Monitor, Heart Rate, Fetal, UltrasonicHEL9210012
Transducer, Ultrasonic, ObstetricHGL060006
Uterine Electromyographic MonitorOSP111003
Tonometer, Ac-PoweredHKX000011
Tonometer, ManualHKY340108
Automated Digital Image Manual Interpretation MicroscopeOEO100001
System, X-Ray, TomographicIZF31111135
Analyzer, Medical ImageMYN100001
C-Arm Fluoroscopic X-Ray SystemRCC00017273
Total322712223101539

An additional 32 devices had from 1 to 32 reports in MAUDE after the PHE began and anywhere from 1 to 78 reports in MAUDE from November 1, 2010 to the start of the PHE. These devices are shown in Table 4.1 below.

Table 4.1—Review Devices with MAUDE Reports Before and After PHE

Device descriptionDevice classProduct codeSection in 21 CFRMAUDE events November 1, 2010 to PHEMAUDE events Post-PHE to November 30, 2020
Vinyl Patient Examination GloveILYZ880.6250401
Mechanical VentilatorIIONZ868.589521
Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism ProtectionIINCP870.421061
Dual Lumen Ecmo CannulaIIPZS870.410024
Respirator, N95, For Use By The General Public In Public Health Medical EmergenciesIINZJ880.626011
Sterilizer Automated Loading SystemIIPEC880.688081
Infusion Safety Management SoftwareIIPHC880.572561
Gown, Isolation, SurgicalIIFYC878.4040121
Non-Normalizing Quantitative Electroencephalograph SoftwareIIOLT882.1400121
Monitor, Ultrasonic, FetalIIKNG884.2660162
Whole Slide Imaging SystemIIPSY864.370021
Oxygenator, Long Term Support Greater Than 6 HoursIIBZG868.1840101
Transmitters And Receivers, Electrocardiograph, TelephoneIIBZQ868.2375388
Start Printed Page 4095
Extracorporeal System For Long-Term Respiratory/Cardiopulmonary FailureIINFB868.5905241
Catheter, Percutaneous, Intraspinal, Short TermIINHJ868.5905182
Implanted Subcutaneous Securement CatheterIINHK868.5905781
Subcutaneous Implanted Apheresis PortIIQAV868.545401
Non-Coring (Huber) NeedleIIBYS870.410001
Administrations Sets With Neuraxial ConnectorsIIDXH870.2920185
Port & Catheter, Implanted, Subcutaneous, IntraventricularIIQJZ870.4100012
Hood, SurgicalIIMAJ868.5120171
N95 Respirator With Antimicrobial/Antiviral AgentIIOKC880.5970161
Reduced- Montage Standard ElectroencephalographIIPTD880.59654032
Monitor, Uterine Contraction, External (For Use In Clinic)IIPTI880.55703610
Coil, Magnetic Resonance, SpecialtyIIPWH880.544005
Solid State Fluoroscopic X-Ray ImagerIILKG882.5550201
Oxygenator, Long Term Support Greater Than 6 HoursIIFXY878.4040201
Transmitters And Receivers, Electrocardiograph, TelephoneIIONT878.404001
Extracorporeal System For Long-Term Respiratory/Cardiopulmonary FailureIIOMC882.140001
Catheter, Percutaneous, Intraspinal, Short TermIIHFM884.2720131
Implanted Subcutaneous Securement CatheterIIMOS892.1000721
Subcutaneous Implanted Apheresis PortIIQHY892.165001

Table 4.2 presents the devices in Table 4.1 broken down by type of MAUDE. Of the 630 MAUDE reports analyzed, the majority (383 or 60.7%) involved product malfunctions with a limited number connected to death (24 or 3.8%).

Table 4.2—Review Devices in Table 4.1 by MAUDE Report

Device descriptionsDevice classProduct codeMAUDE Reports
MalfunctionDeathInjuryOtherNATotal
Vinyl Patient Examination GloveILYZ200191141
Mechanical VentilatorIIONZ111003
Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism ProtectionIINCP205007
Dual Lumen Ecmo CannulaIIPZS114006
Respirator, N95, For Use By The General Public In Public Health Medical EmergenciesIINZJ101002
Sterilizer Automated Loading SystemIIPEC702009
Infusion Safety Management SoftwareIIPHC700007
Gown, Isolation, SurgicalIIFYC12010013
Non-Normalizing Quantitative Electroencephalograph SoftwareIIOLT11200013
Monitor, Ultrasonic, FetalIIKNG21150018
Whole Slide Imaging SystemIIPSY201003
Oxygenator, Long Term Support Greater Than 6 HoursIIBZG7021111
Transmitters And Receivers, Electrocardiograph, TelephoneIIBZQ38530046
Extracorporeal System For Long-Term Respiratory/Cardiopulmonary FailureIINFB11491025
Catheter, Percutaneous, Intraspinal, Short TermIINHJ10190020
Implanted Subcutaneous Securement CatheterIINHK68460179
Subcutaneous Implanted Apheresis PortIIQAV100001
Non-Coring (Huber) NeedleIIBYS100001
Administrations Sets With Neuraxial ConnectorsIIDXH9190423
Port & Catheter, Implanted, Subcutaneous, IntraventricularIIQJZ9120012
Hood, SurgicalIIMAJ12060018
N95 Respirator With Antimicrobial/Antiviral AgentIIOKC12031117
Reduced- Montage Standard ElectroencephalographIIPTD521190072
Monitor, Uterine Contraction, External (For Use In Clinic)IIPTI220240046
Coil, Magnetic Resonance, SpecialtyIIPWH500005
Start Printed Page 4096
Solid State Fluoroscopic X-Ray ImagerIILKG16140021
Oxygenator, Long Term Support Greater Than 6 HoursIIFXY19020021
Transmitters And Receivers, Electrocardiograph, TelephoneIIONT001001
Extracorporeal System For Long-Term Respiratory/Cardiopulmonary FailureIIOMC100001
Catheter, Percutaneous, Intraspinal, Short TermIIHFM10130014
Implanted Subcutaneous Securement CatheterIIMOS130527173
Subcutaneous Implanted Apheresis PortIIQHY100001
Total38324203119630

III. Exemption from 510(k) Premarket Notification Requirement

A. Class I Devices

Section 510(l)(2)(A)-(B) of the FD&C Act, 21 U.S.C. 360(l)(2)(A)-(B), provides that “the Secretary shall identify through publication in the Federal Register, any type of class I device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness” and that “[u]pon such publication—each type of class I device so identified shall be exempt from the requirement for a report under subsection (k); and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.”

In view of the complete lack of or de minimis number of adverse events in MAUDE following FDA's waiver of the premarket notification requirement for the class I devices listed in Tables 2, 3.1, and 4.1, the Department has concluded that the premarket notification requirement is no longer required to provide reasonable assurance of the safety and efficacy of those devices. As such, as of this Notice, the 7 class I devices listed in Table 5 below shall be exempt from the 510(k) premarket notification requirement.

Table 5—Class I Devices Immediately Exempt from 510(k) Notification Requirement

Device descriptionDevice classProduct codeSection in 21 CFR
Powder-Free Polychloroprene Patient Examination GloveIOPC880.6250
Patient Examination Glove, SpecialtyILZC880.6250
Radiation Attenuating Medical GloveIOPH880.6250
Powder-Free Non-Natural Rubber Latex Surgeon”s GlovesIOPA878.4460
Powder-Free Guayle Rubber Examination GloveIOIG880.6250
Latex Patient Examination GloveILYY880.6250
Vinyl Patient Examination GloveILYZ880.6250

B. Class II Devices

Section 510(m)(2) of the FD&C Act, 21 U.S.C. 360(m)(2), provides that, after a 60-calendar-day-notice comment period, “the Secretary may exempt a class II device from the requirement to submit a report under subsection (k) . . . if the Secretary determines that such report is not necessary to assure the safety and effectiveness of the device.” Within 120 days of publication, “the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice.” Given the lack of any adverse event reports in MAUDE for class II and the unclassified medical devices listed in Table 2, and the lack of non-death-related adverse event reports for class II devices in Tables 3.3 and 4.2, the Department has determined that 510(k) premarket notification for the 84 class II devices and the unclassified device listed in Table 6 below is no longer necessary to assure the safety and effectiveness of those devices.

Table 6—Class II Devices and Unclassified Devices Proposed Exempt from 510(k) Requirement

Device descriptionDevice classProduct codeSection in 21 CFR
Ventilator, Continuous, Minimal Ventilatory Support, Home UseIINQY868.5895
Airway Monitoring SystemIIOQU868.5730
Impedance Measuring Device Utilizing Oscillation TechniquesIIPNV868.1840
Gauge, Pressure, Coronary, Cardiopulmonary BypassIIDXS870.4310
Valve, Pressure Relief, Cardiopulmonary BypassIIMNJ870.4400
Oximeter, Tissue Saturation, ReprocessedIINMD870.2700
Multivariate Vital Signs IndexIIPLB870.2300
Electrocardiograph Software For Over-The-Counter UseIIQDA870.2345
Sterilizer, Dry HeatIIKMH880.6870
Check Valve, Retrograde Flow (In-Line)IIMJF880.5440
Start Printed Page 4097
Intravascular Administration Set, Automated Air Removal SystemIIOKL880.5445
Neuraxial Administration Set—Intrathecal DeliveryIIPYR880.5440
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, LiquidIIPSW892.1570
Pediatric/Child FacemaskIIOXZ878.4040
Normalizing Quantitative Electroencephalograph SoftwareIIOLU882.1400
Computerized Cognitive Assessment AidIIPKQ882.1470
Physiological Signal Based Seizure Monitoring SystemIIPOS882.1580
Computerized Behavioral Therapy Device For Psychiatric DisordersIIPWE882.5801
Monitor, Phonocardiographic, FetalIIHFP884.2640
Monitor, Cardiac, FetalIIKXN884.2600
Digital Pathology DisplayIIPZZ864.3700
Digital Pathology Image Viewing And Management SoftwareIIQKQ864.3700
System, Imaging, Holography, AcousticIINCS892.1550
Lung Computed Tomography System, Computer-Aided DetectionIIOEB892.2050
Chest X-Ray Computer Aided DetectionIIOMJ892.2050
Computer-Assisted Diagnostic Software For Lesions Suspicious For CancerIIPOK892.2060
Radiological Computer-Assisted Triage And Notification SoftwareIIQAS892.2080
Radiological Computer Assisted Detection/Diagnosis Software For FractureIIQBS892.2090
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerIIQDQ892.2090
Radiological Computer-Assisted Prioritization Software For LesionsIIQFM892.2080
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software DeviceIIQHA892.1600
Automated Radiological Image Processing SoftwareIIQIH892.2050
Image Acquisition And/Or Optimization Guided By Artificial IntelligenceIIQJU892.2100
Apparatus, Vestibular AnalysisUnclassifiedLXVN/A
Meter, Peak Flow, SpirometryIIBZH868.1860
Oximeter, ReprocessedIINLF870.2700
Stethoscope, ElectronicIIDQD870.1875
Defoamer, Cardiopulmonary BypassIIDTP870.4230
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary BypassIIJOD870.4270
Detector, Bubble, Cardiopulmonary BypassIIKRL870.4205
Cpb Check Valve, Retrograde Flow, In-LineIIMJJ870.4400
Sterilizer, Ethylene-Oxide GasIIFLF880.6860
Cabinet, Ethylene-Oxide Gas AeratorIIFLI880.6100
Purifier, Air, Ultraviolet, MedicalIIFRA880.6500
Cleaner, Air, Medical RecirculatingIIFRF880.5045
Controller, Infusion, Intravascular, ElectronicIILDR880.5725
Cleaners, Medical DevicesIIMDZ880.6992
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter PositionIIOMF880.5970
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical EmergenciesIIORW880.6260
Two Or More Sterilant SterilizerIIPJJ880.6860
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, MistIIOUJ892.1570
Surgical Mask With Antimicrobial/Antiviral AgentIIOUK878.4040
Cerebral OximeterIIQEM870.2700
Device, Sleep AssessmentIILEL882.5050
Standard Polysomnograph With ElectroencephalographIIOLV882.1400
Source Localization Software For Electroencephalograph Or MagnetoencephalographIIOLX882.1400
Automatic Event Detection Software For Polysomnograph With ElectroencephalographIIOLZ882.1400
Amplitude-Integrated ElectroencephalographIIOMA882.1400
Automatic Event Detection Software For Full-Montage ElectroencephalographIIOMB882.1400
Burst Suppression Detection Software For ElectroencephalographIIORT882.1400
Transducer, Ultrasonic, ObstetricIIHGL884.2960
Tonometer, Ac-PoweredIIHKX886.1930
Tonometer, ManualIIHKY886.1930
Automated Digital Image Manual Interpretation MicroscopeIIOEO864.1860
Analyzer, Medical ImageIIMYN892.2070
C-Arm Fluoroscopic X-Ray SystemIIRCC892.1650
Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism ProtectionIINCP870.4210
Respirator, N95, For Use By The General Public In Public Health Medical EmergenciesIINZJ880.6260
Sterilizer Automated Loading SystemIIPEC880.6880
Infusion Safety Management SoftwareIIPHC880.5725
Gown, Isolation, SurgicalIIFYC878.4040
Whole Slide Imaging SystemIIPSY864.3700
Oxygenator, Long Term Support Greater Than 6 HoursIIBZG868.1840
Subcutaneous Implanted Apheresis PortIIQAV868.5454
Non-Coring (Huber) NeedleIIBYS870.4100
Hood, SurgicalIIMAJ868.5120
N95 Respirator With Antimicrobial/Antiviral AgentIIOKC880.5970
Monitor, Uterine Contraction, External (For Use In Clinic)IIPTI880.5570
Coil, Magnetic Resonance, SpecialtyIIPWH880.5440
Start Printed Page 4098
Oxygenator, Long Term Support Greater Than 6 HoursIIFXY878.4040
Transmitters And Receivers, Electrocardiograph, TelephoneIIONT878.4040
Extracorporeal System For Long-Term Respiratory/Cardiopulmonary FailureIIOMC882.1400
Implanted Subcutaneous Securement CatheterIIMOS892.1000
Subcutaneous Implanted Apheresis PortIIQHY892.1650

C. Impact of Exemptions on Patient Access to Medical Devices

With this Notice, the Department is immediately exempting 7 devices from the premarket notification requirement, and proposes to exempt an additional 84 devices from the requirement after public comment is closed. As noted above in Part I.A, estimates on the cost of preparing a 510(k) submission range from $100,000 to $4 million. The exemptions provided for and proposed under this Notice for these 91 device classes could eliminate anywhere from $9.1 to $364 million in startup costs if there were one new entrant into each device market. Savings could further accrue based on each new market entrant. Instead of being costs passed along to patients and taxpayers, these savings could be invested in other areas such as research and development and manufacturing.

At the same time, should these waivers go into effect as proposed, patients stand to gain more immediate access to new products that would otherwise be required to obtain a 510(k) clearance prior to marketing.

The exemptions provided for in this Notice also conserve FDA's scarce review resources. The COVID-19 PHE stretched FDA's review capacity. Under this Notice, FDA's review resources can be redeployed to review other innovative technology, to include devices designed to mitigate the impact of COVID-19.

IV. Request for Information, Data, and Further Study

HHS' review in this Notice warrants expansion and further study. FDA's medical device Product Code database contains 6,651 unique codes (to include those discussed in this Notice). Of those unique codes, 157 are for class I devices that require 510(k) clearance, and 2,662 are for class II devices that require 510(k) clearance. Applying the $100,000 to $4 million in estimated costs for 510(k) preparation and submission to these 2,819 devices yields approximately $281.9 million to $11.276 billion in startup costs, assuming one new market entrant in each of the 2,819 device classes. Further, again assuming a 90-day review period and one new device entrant in each of the 2,819 device classes that require 510(k) notification, FDA's current approach creates 253,710 review days or 695.1 review years between Americans and new devices. The question of whether the 510(k) notice is justified in view of safety and efficacy concerns merits comprehensive analysis for the benefit of Americans. The Department seeks public comment, research, and analysis on whether other devices should be exempt from the premarket notification requirement.

At a more detailed level, the Department observed internal inconsistencies in FDA's regulation of some device classes that merit discussion. Manual stethoscopes are exempt from the premarket notification requirement. 21 CFR 870.1875(a)(2). Electronic stethoscopes are also exempt, but only if the device “is a lung sound monitor.” 21 CFR 870.1875(b)(2). Similarly, FDA exempts “clinical mercury thermometer . . . device[s] used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury” from the 510(k) premarket notification requirement. 21 CFR 880.2920. By contrast, clinical electronic thermometers which never enter into any body orifice require 510(k) premarket notification. 21 CFR 880.2910. These apparent inconsistencies merit scientific scrutiny. To that end, the Department seeks public comment as to whether other inconsistencies in the medical device regulatory framework exist.

Start Signature

Dated: January 8, 2021.

Alex M. Azar II,

Secretary, Department of Health and Human Services.

End Signature End Supplemental Information

Footnotes

1.  Medtronic, Inc. v. Lohr, 518 U.S. 470, 476 (1996).

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2.  Id. at 476-77.

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3.  Lohr, 518 U.S. at 477; see also FD&C Act 513(a)(1)(B), 21 U.S.C. 360c(a)(1)(B).

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4.  Lohr, 518 U.S. at 477.

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6.  See 21 CFR 807.97 (providing that “determination by the Commissioner that the device intended for introduction into commercial distribution is substantially equivalent” to a predicate device “does not in any way denote official approval of the device”).

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8.  Josh Makower, Aabed Meer & Lyn Denend, FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Device Companies, at 7 (Nov. 2010), https://www.medtecheurope.org/​wp-content/​uploads/​2015/​07/​01112010_​FDA-impact-on-US-medical-technology-innovation_​Backgrounder.pdf. During a 2011 hearing before a House subcommittee, the Director for the Center for Devices and Radiological Health (CDRH) raised concerns regarding the methodology used in this study. FDA Medical Device Approval: Is There a Better Way?, Hearing Before the H. Subcomm. on Health Care, District of Columbia, Census and the National Archives, 112th Cong. 29 (2011) (hereinafter the “2011 Hearing”). The CDRH Director's criticisms largely focused on the report's comparison of FDA's regulation of medical devices to the European Union's regulatory system. The CDRH Director otherwise acknowledged that FDA does not “do cost analyses for what the manufacturers are doing” and that the agency “would not know of the total cost to a particular company.” Id. at 32. Here, the Department is citing this study for 510(k) cost and time estimates, not for purposes of comparing the U.S. and E.U. medical device regulatory systems.

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9.  Id. at 22.

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10.  Id. at 7.

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11.  Id. at 22.

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12.  Id. at 29, fig. 10.

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14.  Aylin Sertkaya et al., Analytical Framework for Examining the Value of Antibacterial Products, at 5-3 (Apr. 15, 2014).

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15.  Id. at 5-4.

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16.  40 FR 26142, 26148 (June 20, 1975).

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18.  H.R. Conf. Rep. 105-399, at 96 (1997).

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19.  FDA, Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, at 3 (Apr. 2020), https://www.fda.gov/​media/​136698/​download.

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21.  85 FR 31353, 31356 (May 22, 2020).

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23.  FDA, MAUDE—Manufacturer and User Facility Device Experience, https://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfmaude/​search.cfm.

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25.  E.g., 85 FR 70003, 70006 (Dec. 20, 2019).

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27.  2011 Hearing at 30.

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29.  For example, there was one MAUDE incident where a user reported suffering a third-degree burn after “pouring boiling nitric acid into a beaker and without warning a chemical reaction occurred causing acid to spill onto the wrist.” Nothing in the report indicates the gloves themselves caused the burn or otherwise exacerbated the burn.

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[FR Doc. 2021-00787 Filed 1-14-21; 8:45 am]

BILLING CODE 4150-26-P