3B Medical, Inc. dba Reach Health, Inc.(CMS # 725108)

Issuing Office:

Center for Devices and Radiological Health

United States

WARNING LETTER
CMS # 725108

May 20, 2026

Dear Mr. Shoop:

During an inspection of your firm located in Dublin, OH from December 1, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures iCodeConnect, a cloud-based software device, intended for use in conjunction with Continuous Positive Airway Pressure (CPAP) and Auto-Adjusting Positive Airway Pressure (Auto-CPAP or APAP) ventilator devices, in treating obstructive sleep apnea (OSA) in adults. Your firm also imports and provides complaint handling for APAP and Bilevel Positive Airway Pressure (BPAP) ventilator devices from BMC Medical Co., Ltd. (Beijing, China) to include, but not limited to, Luna G3 APAP (LG3600), G3X APAP (G4600), Luna G3 BPAP (LG3700), Luna G3 30VT (LG3800), and Luna G2 APAP (LG2A02). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Quality System Regulation Violations

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from Rebecca Legare, Quality Systems and Compliance Director, dated January 2, 2026, and February 13, 2026, and from Shalini Yadav, Senior Manager of Regulatory Affairs on March 27, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner and complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a), 820.198(a)(1), and 820.198(a)(3).

Specifically:

A. Your firm failed to implement section 9.1.1 of your “Customer Complaints” procedure (SP.QA.0011; Rev. G-I; Effective: 8/27/24, 12/5/24, 6/27/25) which requires you to “***determine if there is a complaint based on the definition of a complaint above and Complaint Decision Tree***,” as required by 21 CFR 820.198(a). For example:

1. Seven (7) out of eleven (11) complaint records reviewed were cancelled although they met the definition of a complaint defined in your procedure as “Any written, electronic, or verbal communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device following release for distribution.” Examples include:

 CN-028565 (9/5/25) for Luna G3 APAP states “***used it Wednesday and Thursday nights. It collected data that shows in the machine display. But, using the React Health Plus app on my iPhone, when I try to upload the data by scanning the iCode QR+ code, the app appears to scan successfully, but the data does not show in the app***.” The documented justification for cancelling the complaint was “***The device was not returned. Tech Support provided information to the customer about data transmission, and the customer later confirmed that data was being displayed. The ticket was canceled. No issue was confirmed***.” However, this incident meets the definition of a complaint due to alleged concern with performance regardless of whether it was determined to be a use error.

 CN-030142 (10/3/25) for Luna 2 Auto states “***Pt dropped machine and it stopped working***.” The documented justification for cancelling the complaint was “***This issue is not a complaint because the patient dropped the device.***” However, this incident meets the definition of a complaint due to alleged concern with durability, regardless of whether it was determined to be a use error.

From August 28, 2024 to November 21, 2025, your firm cancelled (b)(4) complaints despite allegations for pressure delivery issues (fluctuations, pulsating, surging, etc.), shutdowns, and electronic and software failures (data transmission, modem connectivity, error codes, etc.) with your Luna G3 APAP/BPAP devices; abnormal pressure readings, low oxygen output, and persistent red-light alarms for your Stratus oxygen concentrators; abnormal smells from your Phoenix 5L oxygen concentrators; and durability issues with your Rio masks.

2. Thirteen (13) out of fifteen (15) inquiries reviewed met the definition of a complaint defined in your procedure. Examples include:

 INQ-26292 (8/18/25) for Luna G3 APAP states “***Pt turned machine over on nightstand, causing water to flow back into machine. Machine pressure now fluctuates heavily and constantly***.” The documented justification for not logging this incident as a complaint was “***Because the patient turned the device over on the nightstand, this is considered patient damage, not a complaint***.” However, this incident meets the definition of a complaint due to alleged concern with performance regardless of whether it was determined to be a use error.

 INQ-23277 (6/23/25) for Luna 2 Auto states “***Button on machine is broken***.” The documented justification for not logging this incident as a complaint was “***The device was not confirmed to be received from React Health with a broken button. Since the device is out of warranty, it has been used, and the damage is considered to be customer induced. Therefore, this is not a complaint***.” However, this incident meets the definition of a complaint due to alleged concern with durability regardless of whether it was determined to be a use error or out of warranty.

Your firm has received over (b)(4) records from August 26, 2024, to December 23, 2025, that you classified as inquiries and found that several should have been categorized as complaints because they contained allegations similar to 1(A)(1) for your Luna G3 APAP/BPAP ventilator devices, Stratus and Phoenix oxygen concentrators, and Rio masks. For example, on August 1, 2025, you received an allegation that "***CPAP suddenly started to pulsating in pressure after ramp up***” (INQ-25644) that was logged as an inquiry instead of a complaint.

B. Your firm’s “Customer Complaints” procedure (SP.QA.0011; Rev. G-I; Effective: 8/27/24, 12/5/24, 6/27/25) and “Incident Reporting Procedure” (SP.QA.0013; Rev. G-I; Effective: 8/27/24, 12/5/24, 6/27/25) do not ensure that additional information is requested to evaluate the need for medical device reportability when the alleged issue has the potential to result in a serious injury, as required by 21 CFR 820.198(a)(3). For example, in three (3) out of eleven (11) complaints reviewed, there was no documentation of follow-up questions asked of complainants to determine whether the incidents were reportable although complainants reported incidents of choking and shortness of breath.

 CN-011887 (1/31/25) for Luna G3 APAP states “***that the machine shuts off in the middle of the night***chokes her out and she is afraid to use it***.” There is no additional documentation in the complaint record about whether medical complications occurred, including the nature of the complication, and/or if medical or surgical intervention was required to preclude permanent impairment of a body function/structure. No medical device report (MDR) was filed.

 CN-026089 (7/24/25) for Luna G3 APAP states “***that in the middle of therapy the device will suddenly send burst of hard rapid airflow that wakes him and makes him short of breath***.” There is no additional documentation in the complaint record about whether medical complications occurred, including the nature of the complication, and/or if medical or surgical intervention was required to preclude permanent impairment of a body function/structure. No MDR was filed.

 CN-014116 (2/21/25) for Luna G3 APAP states that the “***device not auto adjusting, pt woke up short of air, device not tracking***.” There is no additional documentation in the complaint record about whether medical complications occurred, including the nature of the complication, and/or if medical or surgical intervention was required to preclude permanent impairment of a body function/structure. No MDR was filed.

C. Your firm failed to implement section 9.1.2 of your “Customer Complaints” procedure (SP.QA.0011; Rev. G-I; Effective: 8/27/24, 12/5/24, 6/27/25) which states that “***Complaints shall be processed in a uniform and in a timely manner***,” as required by 21 CFR 820.198(a)(1). For example, your June 18, 2025 Quality Data Review documents that as of May 2025, there were backlogs of over (b)(4) complaints for your Stratus oxygen concentrator devices and over (b)(4) complaints for your Luna ventilator devices. In addition, review of the (b)(4) complaints received between August 27, 2024 and December 2, 2025 revealed that over (b)(4) complaints were in the workflow status of “open”, “pending approval”, “evaluation in process”, or “investigation in process” for at least (b)(4) or more.

We reviewed your firm’s responses and conclude that they are not adequate. Under CAPA 2504, your firm reviewed FDA-483 observation 1 with your complaint team; re-launched complaint awareness training; updated SP.QA.0011 with an end-to-end complaint investigation workflow to ensure collection of medical and patient outcome information in cases of potential or suspected patient harm; developed a complaint intake tool; provided training on identification of potential patient harm to complaint handling employees; and initiated a retrospective review project of all cancelled complaints and inquiries with a target date of November 1, 2026; and developed an intake ticketing system that defines complaint sources. However, neither the updated SP.QA.0011 or “Customer Contact Form” provide assurance that additional follow-up questions are requested of complainants in cases where sufficient information is not provided (but there is a possibility of patient harm) in order to determine whether the complaint represents an MDR reportable event. Furthermore, no actions were identified to address the backlog of open complaints noted in the 1(C) above or to assess whether staffing levels are adequate. The inspection found that (b)(4) employees, (b)(4) of whom were temporary, were tasked with the responsibility of processing over (b)(4) complaints received during the 15-month period prior to the inspection. Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.

2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Specifically, your firm failed to implement section 10.4 of your “Corrective and Preventive Action (CAPA) Procedure” (SP.QA.0012; Rev. D; Effective: 7/12/23) which requires that the containment phase “***(b)(4).” For example, you initiated CAPA 2408, dated November 25, 2024, due to the shipment of expired Ultra Soft 12 Food Oxygen Cannulae (Part # 02U2012; Lot # (b)(4); Exp: 4/2022) from your warehouse to a customer on October 28, 2024. However, the containment activities only included (b)(4) out of (b)(4) possible warehouses that could receive product. Your firm did not consider the other (b)(4) warehouses to ensure that they were also unable to ship products that are past expiration date.

Moreover, although section 10.4 of SP.QA.0012 states a “***recall, correction, or removal requires CAPA initiation***” and your Manager of Quality Systems and Compliance stated that CAPA 2408 was opened in part to control the field action initiated on November 27, 2024, there is no mention of this field action (RES 95918) in this CAPA record.

We reviewed your firm’s responses and conclude that they are not adequate. Under CAPA 2505, your firm ran a full inventory report for all expiry-dated products across all warehouses; performed a gap assessment on all active Supplier Quality Agreements (SQAs); updated the CAPA 2408 record to document containment verification and include linkage to the field action; and conducted a for-cause supplier audit at the (b)(4) as a follow-up to the Expired Cannula Recall (RES 95918). By May 15, 2026, your firm also plans to add expiration controls to ensure expired products cannot be released or shipped; a requirement for routine inventory checks at all warehouses, including third-party logistics (b)(4) partners; and mandatory review of these results at Management Review meetings. However, there was no action identified to conduct a risk assessment on whether a field action is needed for product released from the additional warehouses which were not accounted for in CAPA 2408 and subsequent field action under RES 95918. This includes the (b)(4) distribution centers operated by (b)(4). Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.

3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, including requirements for analyzing processes, work operations, concessions, quality audit, reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1).

Specifically, the “Matrix, Quality Data Metrics” form (SP.QA.0035.F1; Rev. D; Effective: 10/29/24) used by your firm to trend quality data is inadequate because it does not ensure that reported complaints are analyzed in a manner which detects all potential sources of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(1). Your Quality Data Review (QDR) dated June 18, 2025 identified "Pressure Fluctuation/ Pulsating" as the most frequently reported issue in complaints received from June 2024 to May 2025 across all ventilator devices (G3X APAP, Luna G3 APAP, Luna G3 BPAP, and Luna G3 30VT, and Luna G2 APAP) but no additional analysis was performed to uncover other potential issues that may warrant evaluation for the need for corrective actions. For example, when this same analysis was applied to complaint data from August 27, 2024, to December 2, 2025 for the G3X APAP and Luna G3 APAP devices individually, the highest reported issues differed, with “Damaged/Broken” and “Error Code Message” reported as the most frequently reported allegations, respectively. Your CAPA Log from December 2022 to December 2025 shows that no CAPA has been initiated for damaged or broken G3X APAP devices or error codes associated with Luna G3 APAP devices.

We reviewed your firm’s responses and conclude that they are not adequate. Under CAPA 2505, your firm re-ran complaint trending QDR for December 2024 through May 2025 (6-month review) to depict data by Luna model; re-evaluated "Pressure Fluctuation" Dec 2024 through May 2025 (6-month review) trend that triggered review for potential CAPA or SCAR; and added “investigated issue (root cause)” charts to QDR. However, no supporting evidence was provided to allow review of the adequacy of the revised analysis method applied to the December 2024 to May 2025 complaint data, including the outcome of the assessment for the need for CAPAs as well as the added corrective action in CAPA 2505 to revise SP.QA.0015 and SP.QA.0035 to require ongoing complaint trending by 510(k) model, failure mode, and root cause. Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.

4. Failure to establish and maintain procedures for validating the device design, including risk analysis, as required by 21 CFR 820.30(g).

Specifically, your firm failed to implement section 9.10 of your “Risk Management Process” procedure (SP.QA.0025; Rev. C; Effective: 3/27/23) which states that “***Prior to, or commensurate with, the release for commercial distribution of the medical device***The risk management report shall (b)(4)***.” For example, upon acquisition of the iCodeConnect software on May 8, 2025, your firm accepted an outdated version 1.1 of the Risk Management Report (YF-CSP1-3-02; Effective: 8/13/16) instead of version 4.0 listed in Appendix A of the “Software Copyright Transfer Contract”. Consequently, this 2016 version of the Risk Management Report fails to include an assessment of the risk acceptability of post-production design changes to the iCodeConnect software which transpired between 2018 and 2025 such as (but not limited to) the release of a refactored version in July 2024 and added ability for use with the following ventilator devices:

 Luna G2 APAP in October 2018
 Luna G3 APAP in January 2022
 Luna G3 25A Bilevel in January 2022
 Luna G3 30VT BiPap in February 2023
 G3 X APAP in July 2025

The adequacy of your firm’s responses cannot be determined at this time. Under CAPA 2508, your firm froze software development and design changes for the iCodeConnect software; performed a regulatory assessment for the intent of a health hazard evaluation; created an iCodeConnect quality plan to establish a comprehensive Design History File (DHF), including the risk management file in the QMS; performed training for personnel supporting regulated stand-alone software, DHF requirements, and document control expectations under 21 CFR 820 and ISO 13485; updated the Design Controls procedures to clarify the process that will be used for developing & maintaining regulated software; created an architecture document that describes the scope of iCodeConnect; and performed a Regulatory Assessment of the iCodeConnect software. By May 15, 2026, your firm plans to establish a new, complete and compliant DHF based on the results of the Regulatory Assessment of the iCodeConnect and update and formalize the risk management file for the current version 3.0 of the iCodeConnect. Please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.

5. Failure to establish and maintain procedures to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).

Specifically, your firm failed to implement section 8 of the “Training and Competency Procedure” (SP.HR.004; Rev. C; Effective: 6/28/24) which includes the requirement to “Evaluate Training Effectiveness” after conducting assigned training in the process flow chart. For example, the training record forms (FO.HR.0004) for (b)(4) out of (b)(4) employees who conduct complaint handling and incident reporting revealed that no “Effectiveness Check(s)” were conducted after receiving training on the “Customer Complaint Procedure” (SP.QA.0011) or Electronic Medical Device Reporting (eMDR) Procedure (SP.QA.0013).

The adequacy of your firm’s responses cannot be determined at this time. Under CAPA 2509, your firm performed a training gap assessment, verified training completeness, and conducted training effectiveness checks for the (b)(4) identified employees; updated SP.HR.004 to establish role-based training needs identification, training effectiveness verification methods, and management governance controls; and implemented standardized training tools (e.g., training needs assessment criteria, instructions for use of training effectiveness templates, and monitoring mechanisms) followed with training. Please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.

Unapproved Device Violations
Our inspection revealed that the APAP devices that your firm distributes as Luna G3 APAP and Luna G3X APAP are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with significant changes or modifications without submitting a new premarket notification to FDA, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

According to our records, the most recent FDA clearance for the APAP devices was granted on September 8, 2016, under 510(k) number K153387. The cleared intended use for these APAP devices, branded as Luna® CPAP and Auto CPAP System, was "for single-patient use by prescription in the home or hospital/institutional environment on adult patients." However, the user manuals obtained during the inspection, authored by your firm, and available for public download from your firm's website (https://www.reacthealth.com/sleep/pap-devices) as of May 19, 2026, indicate that the APAP devices are intended "for single-patient re-use in the home environment or for multi-patient re-use in the hospital/institutional environment." This constitutes a major change or modification to the intended use of these devices for which they lack clearance or approval. This major change or modification to the intended use could significantly affect the safety and effectiveness of these devices because multi-patient use introduces risks of cross-contamination and transmission of infectious pathogens between patients, including respiratory viruses and bacteria, that are not present in single-patient use. These risks are new and not addressed by the cleared device's labeling or existing reprocessing instructions, as the device was not evaluated or cleared for the decontamination protocols necessary to ensure patient safety between uses.

FDA’s regulations at 21 CFR 807.81(a)(3)(i) provide that submission of a 510(k) is required for “a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.” FDA requests that your firm cease any activities that result in the misbranding or adulteration of these devices.

For further explanation on the need for a new premarket notification, or "510(k)," for changes to the intended use or design affecting safety and effectiveness, consult the guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov)." The “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff,” is also recommended for obtaining FDA feedback on the 510(k) submission for the modified Luna G3 APAP devices.

Corrections and Removals Violations
Our inspection also revealed that your firm’s Rio II Nasal Pillows devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

1. Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: your Rio II Nasal Pillows devices were packaged in boxes that incorrectly all had one part number on the front and all size checkboxes filled in. The box labels for all sizes incorrectly had the same UDI number, regardless of size. An incorrect sized mask can result in high leaks (when using larger size) or inability to use the mask (when incorrectly using small size). When this happens, the therapy is not provided to the patients with obstructive sleep apnea, which presents a risk to health. You notified Durable Medical Equipment (DME) companies beginning June 22, 2023, to remedy the violation or reduce the risk to health posed by the device. This action is a medical device correction or removal initiated to reduce the risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. As of December 10, 2025, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.

We reviewed your firm’s responses and conclude that they are not adequate. Your responses do not address Reports of Correction or Removal, and your firm has not submitted a Report of Correction or Removal to FDA for the incorrectly labeled Rio II Nasal Pillows as of May 19, 2026.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection from December 1, 2025 to December 10, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose, or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage:
https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Gina Brackett, Establishment Assessment Team 1 Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 725108” when replying. If you have any questions about the contents of this letter, please contact: Sargum Morgan, Compliance Officer at sargum.morgan@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Barbara A. Marsden
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health