Poetry and prose

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above. We cannot determine if the device is substantially equivalent to a legally marketed predicate device based solely on the information that you provided. Therefore, this is to inform you that we are putting your submission on hold. To complete the review of your submission, we require that you address the following (please note that all page numbers listed correspond to those in the submission):

a. Your Indications for Use states that your device is to be used in the home or in the healthcare facilities. An alert statement in your user’s manual (p.175), however, states that the product is designed for single patient use. Please clarify if your device is intended for single patient use (home use only), or for both home use and professional use/multiple patient use.

The letter initially describes the requirements for addressing the intended use of the BGMS (Section 1. Intended Use). In summary, if it is intended for “single patient – home use” only, your IFU statement should clearly state that it is intended to be used by lay users and should only be used by a single person and should not be shared. If it is intended for “multiple patient, professional use”, your IFU statement should clearly state that the device is intended for multiple patients in a professional healthcare setting. We continue to allow sponsors to check “OTC” on the Indications for Use form for the “multiple patient, professional use” device if they have the data to support the OTC claim.

If your device is intended for both single-patient and multiple-patient use, you should market distinct meters for each type of use: one meter type for single patient use and one meter type for multiple-patient use. Each meter type should have separate indications for use (as described in the previous paragraph) in addition to separate names and separate labeling. Please note that each meter type may have the same physical components (e.g. meter, test strips, control solution) and performance data.

You should provide BGMS starter kits for each intended use. The kit for the single patient may contain auto-disabling, a single-use lancing device, or a multiple-use lancing device. The kit for multiple patients can only contain auto-disabling, single use lancing devices. The labeling for the multiple-patient kit should clearly state that only auto-disabling, single-use lancing devices should be used. Furthermore, instructions for how to obtain auto-disabling devices should be provided.

Please read the letter thoroughly to obtain exact requirements for establishing the intended use.

b. Your Indications for Use states that testing sites include fingertip along with palm, forearm, upper arm, thigh, and calf. You have provided the results of consumer studies that support the claim for the fingertip (fingerstick) testing site. You have not, however, provided the results of consumer studies that support the claim for the palm, forearm, upper arm, thigh, and calf. If you intend for the user to test these alternative sites, you should perform additional studies to support the alternative site testing (AST) claim. These studies should be conducted with lay users who perform the test for each alternative site without assistance or coaching, using only the instructions that will be marketed with the device. Study participants should be in “steady state”. We recommend that you design your studies to evaluate performance for each alternative site with test results compared to a laboratory reference method such as YSI. We recommend at least 100 samples per anatomical site. Please provide your study protocol, acceptance criteria, glucose range tested, data analysis, summary, and conclusions or your results.

c. Your Indications for Use indicates that test strips can be used on neonatal blood. You did not provide any testing on neonatal blood. Furthermore, elsewhere in your submission (e.g. p. 129), you indicate that the device should not be used on newborns. Please clarify if you intend for your device to be used on neonates. If you do not intend for your device to be used on neonates, please remove this claim from the intended use and indications for use statement. If you do intend for your device to be used on neonates, we recommend you refer to the guidance “Points to consider for portable blood glucose monitoring devices intended for bedside use in the neonate nursery”. The url for the guidance is here: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094125.pdf. Please note that the use of the device on neonates should be limited to professional use only.

d. You did not provide separate Indications for Use statements for the control solutions and the test strips. Based on your intended use which will determine the types of meters you plan to market, you will need to provide updated Indications for Use statement forms that include statements for each type of test strips and control solutions (please remember that each meter type, as explained above, will have dedicated test strips and control solutions).

e. An example of an Indications for Use statement for a single-patient meter type and for a multiple-patient meter type are below:

The ABC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The ABC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ABC Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ABC Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The ABC Test Strips are for use with the ABC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The ABCMulti Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous whole blood or fresh capillary whole blood from fingertip, palm, or forearm. The ABCMulti Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices.

The ABCMulti Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The ABCMulti Blood Glucose Test Strips are for use with the ABCMulti Blood Glucose Meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

f. Please submit a revised Indications for Use statement form, 510(k) summary, and labeling to reflect the requirements described above.

The letter referenced above also includes a description of requirements for a cleaning and disinfection protocol (Section 2. Validated cleaning and disinfection procedures). You should follow all recommendations provided in this letter as the data from cleaning and disinfection studies are necessary to support the clearance of your devices. We strongly encourage you to submit any questions you may have regarding cleaning and disinfection study protocols and labeling requirements before you conduct these studies. We recognize that addressing these new requirements can be time consuming and costly; therefore, we strongly recommend that you submit your questions and study protocols to us for comment prior to initiating these studies. This is known as a “pre-IDE”, a type of submission that allows a sponsor to receive feedback based, on FDA’s current thinking, on your proposed study (refer to Item VIII. Attachment – Pre-IDE Information Package). You can submit a pre-IDE while your 510(k) is on hold. If you wish to submit a pre-IDE, please send your proposal to our document mail center and identify the submission as a “pre-IDE” for the Division of Chemistry and Toxicology Division.

a. Disinfection Testing – Meters. Please provide one chart (including photos) of materials identifying all of the meters and the materials used to make those meters. You should also link materials specific for each device to the materials you intend to submit for your disinfection studies. Terminology in this chart should match terminology in the disinfection report. Further, a detailed description of the materials used for your glucose meters is needed, including texture, paint/color, and type of plastic material (e.g., ABS) used. If any materials are not tested then you should provide justification explaining why you determined that testing was not necessary.

b. Robustness Testing – Meters. Robustness testing is the resistance of the meters to cleaning and disinfection procedures and should be performed for all glucose meters currently claimed in your submission.

c. Disinfection Testing – Lancing Devices. Materials from the lancing devices should be tested in your disinfection studies as well.

d. Robustness Testing – Lancing Devices. Please provide robustness testing for all lancing devices in your submission.

1. You provided a study protocol and results for the “within-day” precision testing. The protocol states “two tests were performed with each glucose meter” and a “total of 20 replicas were performed by ten glucose meters”. The ISO 15197 standard specifies that 10 measurements are to be performed for each meter per glucose concentration. Please perform a study and data analysis of your “within-day” testing using the specifications outlined in ISO 15197. Please test more than one lot of test strips. Additionally, please provide your study protocol, acceptance criteria, glucose range tested, summary, and conclusions of your results.

2. You provided a study protocol and results for the “inter-meter and inter-reagent strip batch variability precision test”. It states that a mean whole blood glucose concentration of 127 mg/dL was obtained using the YSI reference. Finally, it states that venous whole blood samples were used. The ISO 15197 standard states that an intermediate precision evaluation is to be performed with control materials as samples at three specified concentrations. The standard also states at least 10 meters are to be used. Please perform a study and data analysis of your intermediate precision testing using the specifications outlined in ISO 15197. Additionally, please provide your study protocol, acceptance criteria, glucose range tested, number of days the test was conducted, summary, and conclusions of your results.

You provided a study protocol and the results for the consumer (lay user) study which also served to demonstrate accuracy.

1. The protocol does not conform to the ISO 15197 standard for system accuracy. For example, the protocol and results do not show the concentrations of samples specified in the ISO standard. Please provide a study protocol, data analysis, acceptance criteria, glucose range tested, number of days the test was conducted, number of patients, summary, and conclusion of your results for the consumer study and system accuracy as outlined in the ISO 15197 standard. Please note that the lay user study should not contain any unaltered samples and there must be some samples with concentrations below 75 mg/dL. Also, the system accuracy study must show performance by the lay user relative to the YSI reference, and the professional relative to the YSI reference. Additionally, the accuracy study can only use altered samples at concentrations <50 mg/dL and >400 mg/dL. Please identify the altered samples in your report.

2. Your results for accuracy do not follow the analysis and presentation as specified in the ISO standard. Please present your data as specified in the ISO 15197 standard. An illustration is below:

Within ±5 mg/dL	Within ±10 mg/dL	Within ±15 mg/dL

Within ±5 %	Within ±10 %	Within ±15 %

Please ensure you calculate results based on one measurement and not an average of replicates.

3. You may incorporate the alternative site testing with this lay user study (please refer to Section 1, paragraph b above). Please present the results vs. YSI, for each anatomical site being claimed, for example, palm results vs. YSI, forearm results vs. YSI, etc. Additionally, please include the linear regression analysis for the comparisons by lay users vs. YSI.

You provided a study protocol and the results for the point-of-care (POC) and physician’s office laboratory (POC) testing.

1. The POC protocol describes a procedure for comparing your device to the YSI reference. Please clarify if this study was supposed to demonstrate accuracy. If so, you will need to follow the ISO 15197 guidelines for system accuracy. Please refer to Item III.b.

2. The POL protocol describes a procedure for comparing the capillary samples to plasma samples derived from venous blood. Your intended use lists venous blood as another type of matrix to be tested. Please provide the results of a study comparing venous blood samples on your device to those using the YSI reference.

3. Your overall protocol mentions arterial blood samples, but neither the POC nor the POL specific protocol mention arterial blood samples. Furthermore, the results do not indicate that arterial blood was tested. Your intended use lists arterial blood as another type of matrix to be tested. Please provide the results of a study comparing arterial blood samples on your device to those using the YSI reference.

4. If you intend for the POC/POL study to support matrix comparisons, we recommend you follow CLSI guideline EP14-A2 “Evaluation of Matrix Effects”.

You tested exogenous, endogenous, anticoagulant and preservative compounds for your interference study.

1. Your protocol states that the test range of exogenous substances ranges from each substance’s highest therapeutic amount up to the maximum test level amount. Please clarify if the minimum amount will represent the minimum concentration available on the market. We are concerned that the highest therapeutic amount may be too high. We recommend you follow CLSI EP7-A2 “Interference Testing in Clinical Chemistry”, in particular Appendix C. Interference Test Concentrations, to ensure you cover the appropriate therapeutic range.

2. Your study included anticoagulant compounds that were spiked into samples after they were collected. This is not an acceptable way of testing anticoagulants. In order to indicate acceptable anticoagulants, the sample must be collected in a tube already containing the anticoagulant. Please perform matrix studies that span the claimed range of your device by testing the anticoagulant using your device and comparing the results to the YSI reference. Please provide a detailed description of the study including a description of the samples, how the samples were prepared, the glucose concentrations, the number of meter, the number of test strip lots. Please include the results of the regression analysis and a description of the statistical method used.

3. Your glucose concentration range seems to run from approximately 70 – 280 mg/dL, depending on the compound being tested. We consider this range too narrow as it does not adequately span your claimed range of 20 – 600 mg/dL. Please provide the results of your interference study using a concentration range that spans the claimed range of your device. We recommend your range be consistent for all compounds tested.

4. Please provide a summary of results that show the limit of interference for each compound tested.

5. A limitation of interference for any tested compound that does not meet the acceptance criteria must be stated in the test strip package insert.

You provided the study protocol and results of a high altitude test to demonstrate the performance of your device at an altitude up to 10,000 feet.

1. Your tested concentrations include three different levels with a range of approximately 84 – 270 mg/dL. We recommend that you include at least one concentration less than 84 mg/dl and one or two greater than 270 mg/dl.

2. Your results display the percent bias relative to the YSI reference method based on averages. Please provide the percent bias relative to the YSI device based on each replicate and not on averages.

3. Your acceptance criteria state that each bias result should not exceed 15%. We consider your acceptance criteria too broad. Please provide the results of your test using narrower acceptance criteria within a clinically acceptable range.

You provided the study protocol and results of a temperature test to demonstrate the performance of your device in a temperature range of 8-44 °C (46.4 – 111.2 °F) and constant humidity of 45%.

1. Your specifications in your user manual indicate that the device can be operated in 10 – 90% humidity. Please provide the results of your study to support the claims for the claimed humidity range.

2. Your study should test the extreme conditions (i.e. lowest and highest temperature combined with lowest and highest humidity). Please provide results of your temperature study that incorporates extreme temperature and humidity combinations.

3. We consider your acceptance criteria of 15% bias too broad. Please provide the results of your test using narrower acceptance criteria within a clinically acceptable range.

You provided the study protocol and results of a linearity study to establish your claimed glucose concentration range of 20 – 600 mg/dL.

1. You state in your protocol that one lot of glucose test strips was used. Please provide the results of your study using multiple lots of test strips.

2. You state in your protocol that the mean value of each aliquot was used in the regression calculations. Please provide the results of your study using the individual replicate, rather than the mean, per aliquot in the regression analyses.

3. Your protocol does not contain acceptance criteria. Please state the acceptance criteria and state whether the results met the acceptance criteria.

You provided the study protocol and results of a stability test to determine the shelf life of the test strips by real time monitoring.

1. Your protocol states to keep blood glucose test strips away from sunlight and humidity. Please provide an actual humidity level or range.

2. Your protocol states that you tested 1 lot of strips. We do not consider this to be an adequate number of lots. Please provide the results of your stability study based on multiple lots of strips.

3. Your user manual states that the control solution is good for 90 days after opening or until the expiration date on the label. Your stability study provides data to support the stability claim for the test strips, but not the control solution. Please provide the protocol and acceptance criteria of your stability study to support the claimed stability of the control solution.

You provided the study protocol and results of a hematocrit test to support the claimed acceptable hematocrit range of 30 – 55%.

1. Your protocol used one glucose concentration in the following set of ranges: 50 – 100 mg/dL, 100 mg/dL, 200 – 300 mg/dL. We recommend you test more than three concentration levels.

2. Your results display the bias relative to the YSI reference using averages. Please calculate the bias relative to the YSI reference using individual replicates.

You submitted the image of the meter box label that is illegible. Please provide an image whereby all text on the box can be easily read in PDF.

1. The label describes three control solution ranges as “low”, “normal”, and “high”. These labels may confuse the user into thinking that these correspond to blood glucose measurements. We suggest renaming the concentrations numerically (e.g. “1”, “2”, “3”) or alphabetically (e.g. “a”, “b”, “c”).

2. The label states the enzyme as glucose dehydrogenase. The enzyme glucose oxidase is mentioned elsewhere in the submission, for example, Section 11, Device Description (p. 27), potential hazard and effect analysis (p. 302 - 307), similarities and differences table (p. 531). Please clarify the type of enzyme used in this device. Please ensure this is properly displayed on all labeling.

3. The vial label lists a website address, XXXXX, that does not appear to exist. Please clarify if this address is functional. If you intend to list a web address, please ensure it is functional.

4. Both labels list a toll-free number, 1-800-XXX-XXXX. Repeated attempts have been made to contact a live person who is affiliated with this device using this phone number. We are concerned that this is not a customer service number. Please provide an active toll-free U.S. customer service number to provide assistance on behalf of your company for your device. Please state the operating days and hours. Please ensure that all customer service representatives who answer the phone are able to answer basic questions about your device in English. We will call and verify that the number is operational, connects to a live voice, and that customers will be given appropriate support.

You submitted the image of the control solution box label for the “normal” concentration level.

1. Please label the concentration for all three control solutions numerically or alphabetically as mentioned in item IV.b.1. Please submit a revised image of the box label for the control solution.

2. The box and vial label both contain the concentration range of the control solution. These ranges are expected to vary with different test strip lots. As such, please remove the ranges from the control solution box and vial labels.

1. The section “Important Information”, p. 123, indicates that meter is not to be used on newborns. Your indications for use statement, however, claims use of the meter on newborns. Please clarify if you intend to use this meter on newborns. If not, please remove this claim from the indications for use.

2. The section “Important Information”, p. 123, indicates that abnormally high (above 60%) or low (below 20%) hematocrit levels can lead to incorrect test results. Your hematocrit study supports the claimed range of 30 – 55%. Your user manual specifications (pps. 29 and 175) state a hematocrit range of 35 – 55%. Your test strip specifications (p. 187) states a hematocrit range of 20 – 70%. Please clarify the exact range of the hematocrit intended to be acceptable when using the device, based on the range supported by your hematocrit study data. Please ensure this range is consistently displayed in all labeling.

3. The manual indicates that your device is equipped with audio capabilities (pp. 127 and 163). Please describe the function of the audio (e.g. the type of information it provides), and how you validated this feature.

4. The section “Important Information”, p. 129, states an operating range of 10 – 600 mg/dL. This range is for a neonatal claim. The operating range throughout the submission, however, is stated as 20 – 600 mg/dL. Please clarify the intended operating range. Please ensure this range is consistently displayed in all labeling. If you intend to make a neonatal claim, please refer to Item I.c. for more information.

5. The section “Important Information”, p. 129, states a storage temperature range of 36 – 90 F for the test strips and an operating temperature range of 46 – 107 F for the test strips. The storage temperature range on the test strip box label states a range of 36 – 86 F. The user manual specifications on page 175 state an operating temperature range of 50 – 104 F. Please clarify the appropriate storage temperature range and operating temperature range for the test strips. Please ensure these ranges are consistently displayed in and on all labeling.

6. The glucose control levels (p. 131) provide “lo”, “mid”, and “hi” labels. Please replace these with numeric or alphabetical labels as mentioned in Item IV.b.1.

7. On page 135 and 156, the user manual indicates that the meter can store about 1000 tests under normal conditions. The user manual specifications (p. 175) state that the memory can store 300 results with date and time. Please clarify if the 1000 tests correspond to the 300 results with date and time. If they do not, please provide the correct number of stored results intended for the device. Please ensure this number is consistently displayed in all labeling.

8. On page 137, the user manual states that the meter can test blood glucose on a user’s forearm, fingers, upper arm, palm, thigh, and calf. All of the sites other than the fingers are considered alternative sites and you have not conducted adequate studies to demonstrate the device can correctly measure glucose from these sites. Please refer to Section I (Intended Use/Indications for Use), paragraph b, regarding the alternative site testing.

9. On page 148, the user manual provides the suggested blood glucose range for an adult with diabetes. We do not recommend this and suggest you provide the expected blood glucose range for an adult without diabetes. Please provide values from in-house studies or up-to-date references. Please display these values in the appropriate labeling.

10. On page 169, the user manual describes the steps to care for the meter, including cleaning the meter with a damp cloth and mild soap or detergent. We do not consider this adequate to ensure the meter is safe between testing. Please refer to the addendum letter for further information regarding validated cleaning and disinfection procedures.

11. On page 174, the user manual cites various compounds that will not affect test results when occurring in normal blood concentrations, but will lead to inaccurate results in abnormally high concentrations. Please provide the lowest concentration of each compound that will yield inaccurate results.

12. On page 175, the user manual lists specifications of various parameters with which to operate the device. Please ensure that all specifications are consistent throughout the manual and labels, and that the all specified claimed ranges have data to support the claim.

13. On a few pages (for example, p. 123, 176, etc.), you list your customer service number. We are concerned that this number is not operational. Please refer to Item IV.b.4 for more information. Please ensure an operational number is consistently listed in the user manual.

14. On a few pages (for example, p. 168, 176, etc.), you list your website address. We are concerned that this address does not exist. Please refer to Item IV.b.4 for more information. If you plan to list your website, please ensure that an active website with live links is in place.

1. The “Storage & Handling” section states storage temperature of 36 – 90 F, but the box and vial labeling state 39 – 86 F. Please provide the correct range in this section and ensure it is consistently displayed in all appropriate labels.

2. The “Blood Glucose Test Procedure” is bulleted for a majority of the steps. We recommend you enumerate or alphabetize all steps.

3. The “Normal Glucose Value” section provides a suggested normal blood glucose range for an adult with diabetes. We do not recommend and suggest you provide the expected blood glucose range for an adult without diabetes. Please provide values from in-house studies or cited from up-to-date references.

4. Please include the accuracy summaries for each anatomical site (fingertip and each alternative testing site) and each matrix (venous, arterial, neonate). The data for each summary should comply with the data presentation for accuracy in the ISO standard. Please refer to item III.b.2 for more information.

5. Please ensure the specifications listed are consistent throughout the manual and labels, and that all specified claimed ranges have data to support the claim.

6. Please ensure that your information and limitations section is consistent with your intended use and indications for use statement. Please ensure that all stated claimed ranges or levels are consistent throughout the labeling and that they have data to support the claim.

7. The insert lists a website and telephone number for customer service support. It is apparent that these methods of contact are not operational. Please refer to Item IV.b.4. for more information.

1. Please specify, in the intended use, the devices that the control solution can be used with your control solution.

2. In the “Performing a Control Solution Test”, please recommend that two levels of controls should be tested. Additionally, since the meter has memory abilities, please state whether or not the control solution values are retained.

3. The insert lists a website and telephone number for customer service support. It is apparent that these methods of contact are not operational. Please refer to Item IV.b.4 for more information.

You provided the results of the user evaluation administered to 60 respondents who operated your device and filled out a questionnaire. Please provide a copy of the post-testing questionnaire administered to the participants. Please note that if you choose to perform alternative site testing, you will need to administer a post-questionnaire to those lay users as well. The questionnaire should evaluate the user’s ability to follow the user manual, and their understanding of the test results and how to use the information, as well as ease of use of the device. The format of the questions should permit participants to grade or scale their responses, e.g. they should choose one of 5 possible answers to the question rather than answering “yes” or “no”. Additionally, the users should be able to provide comments or suggestions.

It is not apparent in your submission that you provided a readability assessment. Please provide a readability assessment (in terms of grade level) for each user manual (including the data transmission software user manual), test strip insert, and control solution insert. For an over-the-counter product, these labels should be at an 8^th grade reading level or lower. An example of a reading assessment tool, the Flesch-Kincaid Readability Score can be found at http://www.rfp-templates.com/Readability-Scores/Flesch-Kincaid-Readability-Score.html.

a. Your meter has a USB port for data transmission to a PC. We are concerned that data may not be transmitted correctly in the intended use setting. We regularly ask at a minimum, that glucose meter data should be transmitted using lay-users to a cleared diabetes data management system. In your instructions for use indicates the USB port can transmit data to the XXXXXX Health system over the internet. We do not have a record of the XXXXXX Health system clearance. Clearing these functions is more involved than just clearing the glucose meter, and is beyond the scope of this review. Please remove all reference to the USB port, data transmission and XXXXXXX Health system. We suggest you submit a protocol for review under the pre-IDE program (Section VI. Attachments) for the USB data transmission functions and for the XXXXXX Health system.

b. The meter has a choice of mg/dL or mmol/L. In the US we have concerns over mixing these units up and the results being misinterpreted. We expect all meters sold in the US to default to mg/dL on initial setup, when changing the batteries and during the use of the meter, unless the unit of measurement is intentionally changed by the user. Please supply software documentation and updated labeling to support these requirements.

c. You have provided traceability information in a reference format which is difficult to review. As per FDA premarket software guidance, a traceability analysis should link together your product design requirements, design specifications, and testing requirements. Please provide traceability information/data in a matrix format. A Matrix format allows linking of hazard identification and mitigation information with software requirements, validations, test results, etc. This can be in the form of an updated hazard analysis table formatted as below to include identified hazards with requirement/mitigation id (brief description), and testing id (brief description) with pass/fail results.

Haz ID

Cause(s)

Risk level before mitigation

Risk level after mitigation

Requirement and/or mitigation desc.

Req. ID

Test Desc.

Test ID

Test

Result

(P/F)

The software and other documentation indicate there are a microphone, earphone and speaker. Please describe the functions of these components.

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Please note that additional issues or deficiencies may be identified as the submission undergoes further review and/or based upon your response to these deficiencies. Please do not hesitate to contact me if you have any questions or concerns.