(253 days)
Not Found
No
The device description and intended use clearly define a physical sharps container with no mention of software, data processing, or any AI/ML related terms.
No
The device is a sharps container for the safe collection and disposal of hazardous sharps, not for therapeutic treatment.
No
Explanation: The device is a sharps container used for the safe collection and disposal of hazardous sharps, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical container made of a body and lid, available in different sizes, and can be used with a stainless steel pedal frame cart. This is a hardware device for collecting and disposing of sharps.
Based on the provided information, the MAUSER PG II Sharps Container is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the safe collection and disposal of hazardous sharps in healthcare facilities. This is a waste management function, not a diagnostic one.
- Device Description: The device is a container designed to hold sharps. It does not perform any tests or analyses on biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to provide diagnostic information. The MAUSER PG II Sharps Container's purpose is solely for the safe containment of hazardous waste.
N/A
Intended Use / Indications for Use
MAUSER PG II Sharps Container is intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, veterinarian offices and other waste generators for the safe collection and disposal of hazardous sharps.
MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.
The single-use, non-sterile device is intended for over-the-counter use. The manufacturer's pedal bin frame is required if the device is used on medication carts. The pedal bin frame cart is constructed of stainless steel and comes fully preassembled. The cart offers a hands free collection option and fully integrates with all sizes of container and lid styles.
The full containers are collected and transported by a licensed health care waste contractor for disposal in accordance with federal and state regulations.
Product codes
MMK
Device Description
MAUSER PG II Sharps Container is a single-use device, which consist of rectangular body and available in three sizes 30 liter, 50 liter and 60 liter. Each container has two parts, the body and the lid, which assemble together to form a unit. Two lid styles are available: grip, and click with port hole.
MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.
Manufacturer offers a stainless steel pedal frame cart that offers a hands free collection process and integrates with all sizes of container and lid type.
The container is designed for safe collection and disposal of sharps, i.e. items that can cause puncture wounds, cuts or tears in skin or mucous membranes, including, but not limited to hypodermic, surgical, suture, and IV needles; Pasteur pipets, lancets, razors, scalpels, and other blades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MAUSER PG II Sharps Container is intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, veterinarian offices and other waste generators.
Target population: Healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No FDA performance standard for MAUSER PG II Sharps Container have been established. The following tests were performed to ensure that the performance of the subject device meets MAUSER USA, LLC. requirements.
-
Puncture resistance
- Test Method: ASTM F2132-01 (Reapproved 2008) Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps.
- Results: Pass. Puncture resistance was measured by taking various sections of container and subjecting them to penetration with a 21 gage by 1 inch needle. The force required to puncture the container was measured. The puncture resistance of each section of the container was greater than 15 N and the passing criterion was met.
-
Drop test (Impact resistance)
- Test Method: §178.603 United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199
- Results: Pass. Drop test was conducted by filling six containers to maximum authorized gross mass (60 liter -30 kg; 50 liter -28 kg; 30 liter -15 kg) with simulated medical waste. The containers were then conditioned at -18° C for 24 hours and dropped in specific orientations from a height of no less than 1.2 meters. No release of contents was observed and the passing criterion was met.
-
Leak resistance test
- Test Method: §173.197 Regulated medical waste (United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199)
- Results: Pass. Leak resistance was conducted by filling container to rated liquid capacity with water. The containers were then closed as per closing instructions and positioned upside down on cardboard paper to show any evidence of leaking. Contained upside down for 60 minutes while being observed for leakage. No leakage was observed and the passing criterion was met.
-
Stack Test
- Test Method: §178.606 (c) (United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199)
- Results: Pass. Containers were filled to the required test capacity and closed as for shipment. Each container was subjected to a force applied to the top surface equivalent to the total weight of identical packages which might be stacked on it during transport. The minimum height of the stack, including the test sample, was 3 meters. Upon completion of the stack test, containers were observed for deformation. The containers did not deteriorate or release contents, and the passing criteria were met.
-
Vibration Test
- Test Method: §178.608 (United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199)
- Results: Pass. Containers were filled with simulated medical waste, closed as for shipment and placed on vibration table. The containers were then vibrated sing a vibration with a 1 in. vertical peak-to-peak displacement, for 60 minutes at a frequency that causes them to be raised enough such that a piece of material 1.6-mm thick can be passed between the container and the vibration platform. The containers did not rupture, leak or deteriorate, and the passing criteria were met.
-
Stability
- Test Method: ISO 23907 Sharps Injury Protection - Requirements and test methods - Sharps Containers (First Edition 2012-09-01)
- Results: Pass. Container stability was evaluated by filling containers with a material of density 0.20+/-0.01 kg/l and placed on an incline with a minimum angle of 15°. Testing was conducted for each side of the container. The container did not slide or topple and the passing criteria were met.
-
Strength of handles
- Test Method: ISO 23907 Sharps Injury Protection - Requirements and test methods - Sharps Containers (First Edition 2012-09-01)
- Results: Pass. Handle strength was measured by filling container to 150% of its authorized gross mass and suspending it from handles for an hour at 23+/-5°C. The containers remained intact and handles did not rupture, tear. crack, or separate from the container and the passing criteria were met.
Clinical data were not submitted in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Oak Ridge Products LLC. Sharps Containers (K130281) O, Oak Ridge Products LLC. Multi-purpose Sharps Containers (K141759) O
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
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1
Image /page/1/Picture/2 description: The image shows the word "MAUSER" in large, bold, blue letters. Above the "M" is a small, red, downward-pointing triangle. The font is sans-serif and the letters are spaced closely together. The overall impression is one of strength and precision.
510K SUMMARY
5.1 SUBMITTER
MAUSER USA, LLC. 2 Tower Center Drive, 20th floor East Brunswick, NJ 08816 Telephone: (732) 353-7015 Fax: (732) 353-7030
Contact person: Tatiana Smoleeva Date prepared: November 1, 2017
5.2 DEVICE NAME AND CLASSIFICATION
Common name: Classification Name: Classification Regulations: Product Code: Trade/Proprietary Name:
Sharps container Hyperdermic single lumen needle 21 CFR 880.5570, Class II MMK MAUSER PG II Sharps Container
5.3 PREDICATE DEVICE
MAUSER PG II Sharps Container is substantially equivalent in indications and design principle to the following predicate devices
- Oak Ridge Products LLC. Sharps Containers (K130281) O
- Oak Ridge Products LLC. Multi-purpose Sharps Containers (K141759) O
DEVICE DESCRIPTION 5.4
MAUSER PG II Sharps Container is a single-use device, which consist of rectangular body and available in three sizes 30 liter, 50 liter and 60 liter. Each container has two parts, the body and the lid, which assemble together to form a unit. Two lid styles are available: grip, and click with port hole.
MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.
Manufacturer offers a stainless steel pedal frame cart that offers a hands free collection process and integrates with all sizes of container and lid type.
The container is designed for safe collection and disposal of sharps, i.e. items that can cause puncture wounds, cuts or tears in skin or mucous membranes, including, but not limited to
MAUSER USA. LLC. 2 Tower Center drive, 20th floor East Brunswick, NJ 08816 USA
Managing Director
Hans-Peter Schaefer, CEO
Bjorn Kreiter, CFO
al Court : Cologne
info.us@mausergroup.com www.mausergroup.com
CONFIDENTIAL
2
Image /page/2/Picture/2 description: The image shows the word "MAUSER" in blue, with a red triangle above the "M". The font is bold and sans-serif. The word is likely a logo or brand name. The overall impression is clean and professional.
hypodermic, surgical, suture, and IV needles; Pasteur pipets, lancets, razors, scalpels, and other blades.
The following MAUSER PG II Sharps Container models and accessories are described in this submission:
| Model or part | Product Description and Closure Type | Overall size
(mm) | Aperture (mm) |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------------------------|
| 060V4080RO
060V4080GE
060V4080Z0
060V4080WI | MAUSER PG II Sharps Container, 60
liter, Grip lid (Red, Yellow, Black,
White w/blue lid) | (L) 376 x (W)
309 x (H) 640 | (L) 375 x (W) 305 |
| 050V4080RO
050V4080GE
050V4080ZW
050V4080WI | MAUSER PG II Sharps Container, 50
liter, Grip lid,
(Red, Yellow, Black, White w/blue lid) | (L) 376 x (W)
309 x (H) 534 | (L) 375 x (W) 305 |
| 030V4080RO
030V4080GE
030V4080ZW
030V4080WI | MAUSER PG II Sharps Container, 30
liter, Grip lid
(Red, Yellow, Black, White w/blue lid) | (L) 376 x (W)
309 x (H) 312 | (L) 375 x (W) 305 |
| 060V4080RO
060V4080GE
060V4080Z0
060V4080WI | MAUSER PG II Sharps Container, 60
liter, Click lid w/porthole
(Red, Yellow, Black, White w/blue lid) | (L) 376 x (W)
309 x (H) 640 | (L) 375 x (W) 305(Major)
152 (porthole diameter) |
| 050V4080RO
050V4080GE
050V4080ZW
050V4080WI | MAUSER PG II Sharps Container, 50
liter, Click lid w/porthole
(Red, Yellow, Black, White w/blue lid) | (L) 376 x (W)
309 x (H) 534 | (L) 376 x (W) 309(Major)
152 (porthole diameter) |
| 030V4080RO
030V4080GE
030V4080ZW
030V4080WI | MAUSER PG II Sharps Container, 30
liter, Click lid w/porthole
(Red, Yellow, Black, White w/blue lid) | (L) 376 x (W)
309 x (H) 312 | (L) 376 x (W) 309(Major)
152 (porthole diameter) |
| 710374 (Red)
710371(Black)
710258 (Yellow)
710303 (Blue) | Grip lid | (L) 395.5 x (W)
329 | NA |
| 700260 (Red)
700156 (Black)
700256 (Yellow)
700901 (Blue) | Click lid w/porthole | (L) 395.5 x (W)
329 | 152 (porthole diameter) |
| N/A | Steel pedal bin frame | N/A | N/A |
INDICATIONS FOR USE 5.5
MAUSER USA, LLC. 2 Tower Center drive, 20th floor East Brunswick, NJ 08816 USA Managing Director Hans-Peter Schaefer, CEO Bjorn Kreiter, CFO
Registered Seat 50321 Brüehl
Local Court : Cologne Registration HBB 58469
3
Image /page/3/Picture/2 description: The image shows the word "MAUSER" in a bold, sans-serif font. The word is blue, and there is a red triangle above the "M". The triangle is pointing downwards. The overall design is simple and modern.
MAUSER PG II Sharps Container is intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, veterinarian offices and other waste generators for the safe collection and disposal of hazardous sharps.
MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.
The single-use, non-sterile device is intended for over-the-counter use. The manufacturer's pedal bin frame is required if the device is used on medication carts. The pedal bin frame cart is constructed of stainless steel and comes fully preassembled. The cart offers a hands free collection option and fully integrates with all sizes of container and lid styles.
The full containers are collected and transported by a licensed health care waste contractor for disposal in accordance with federal and state regulations.
5.6 EQUIVALENCE TO MARKETED DEVICE
MAUSER USA, LLC. Submits the following information in this premarket notification to demonstrate, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indication and design principle to the following legally marketed predicate device:
| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| MAUSER PG II Sharps | |||
| Container | Oak Ridge Products Sharps | ||
| Containers (K130281) | Oak Ridge Products Multi- | ||
| purpose Sharps Containers | |||
| (K141759) | |||
| MAUSER USA, LLC. | |||
| 2 Tower Center Drive, 20th | |||
| floor | |||
| East Brunswick, NJ 08816 | |||
| USA | Oak Ridge Products L.L.C | ||
| 4612 Century Court | |||
| McHenry, Illinois, 60050 | |||
| USA | Oak Ridge Products L.L.C | ||
| 4612 Century Court | |||
| McHenry, Illinois, 60050 | |||
| USA | |||
| Target | |||
| population | Healthcare professionals | Healthcare professionals | Healthcare professionals |
| Indication for | |||
| use | MAUSER PG II Sharps | ||
| Container is intended to be | |||
| used in healthcare facilities | |||
| including nursing stations, | |||
| medication carts, | Oak Ridge Products Sharps | ||
| containers are single-use, | |||
| disposable, non-sterile | |||
| containers intended to be used | |||
| for healthcare purposes for | |||
| safe disposal of hazardous | Oak Ridge sharps containers | ||
| are intended to be used for | |||
| the safe disposal of | |||
| hazardous sharps |
- Oak Ridge Products LLC. Sharps Containers (K130281) O
- Oak Ridge Products LLC. Multi-purpose Sharps Containers (K141759) O
MAUSER USA. LLC 2 Tower Center drive, 20th floo East Brunswick, NJ 08816 US/
Managing Director Hans-Peter Schaefer, CEO Registered Seat 50321 Brüe Local Court : Cologne
4
Image /page/4/Picture/2 description: The image shows the word "MAUSER" in large, bold, blue letters. Above the "M" is a red triangle pointing downwards. The font is sans-serif and the overall design is clean and modern.
| MAUSER USA LLC, 2 Tower Center Drive 20th floor, East Brunswick, New Jersey 08816 USA | |||
|---|---|---|---|
| laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, veterinarian offices and other waste generators for the safe collection and disposal of hazardous sharps. | sharps such as hypodermic needles, syringes, lancets, and blood needles. | ||
| Performance | Single use | Single use | Single use |
| Manufacturing | Injection molded | Injection molded | Injection molded |
| Materials of construction | Polypropylene | Polypropylene | Polypropylene |
| Color | Red, yellow, black, white | Red, natural | Red |
| Sharps elimination | Sharps inserted through the top | Sharps inserted through the top | Sharps inserted through the top |
| Method of visualizing the fill line | Large apertures opening provides clear and unrestricted view of fill line | A translucent container component provides view of fill line | A translucent container component provides view of fill line |
| Mounting Accessory | Available for use on medication carts | Available and necessary for 1 quart and 5.4 quart models | Unknown |
| Impact resistance (Drop test) | Yes | Yes | Yes |
| Vibration test | Yes | Unknown | Unknown |
| Stack test | Yes | Unknown | Unknown |
| Puncture resistance | Yes | Yes | Yes |
| Leak Resistance | Yes | Yes | Yes |
5.7 PERFORMANCE DATA
No FDA performance standard for MAUSER PG II Sharps Container have been established. The following tests were performed to ensure that the performance of the subject device meets MAUSER USA, LLC. requirements.
| Test | Test Method | Results | |
|---|---|---|---|
| 1 | Puncture resistance | ASTM F2132-01² (Reapproved 2008) | Pass |
| 2 | Drop test (Impact | ||
| resistance) | §178.603¹ | Pass | |
| 3 | Leak resistance test | §173.197¹ Regulated medical waste | Pass |
| 4 | Stack Test | §178.606¹ (c ) (1) | Pass |
MAUSER USA, LLC.
2 Tower Center drive, 20th floor
East Brunswick, NJ 08816 USA
Managing Director Hans-Peter Schaefer, CEO Bjorn Kreiter, CFO
Registered Seat 50321 Brüehl
Local Court : Cologne Registration HBB 58469
5
| 5 | Vibration Test | §178.608¹ | Pass |
|---|---|---|---|
| 6 | Stability | ISO 23907³ | Pass |
| 7 | Strength of handles | ISO 23907³ | Pass |
1United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199
2 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
3 Sharps Injury Protection - Requirements and test methods - Sharps Containers (First Edition 2012-09-01)
Puncture resistance – ASTM F2132-01 (Reapproved 2008) Standard Specification for Puncture Resistance of Materials used in Containers for Discarded Medical Needles and Other Sharps.
Puncture resistance was measured by taking various sections of container and subjecting them to penetration with a 21 gage by 1 inch needle. The force required to puncture the container was measured. The puncture resistance of each section of the container was greater than 15 N and the passing criterion was met.
Drop test - $178.603 (United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199)
Drop test was conducted by filling six containers to maximum authorized gross mass (60 liter -30 kg; 50 liter -28 kg; 30 liter -15 kg) with simulated medical waste. The containers were then conditioned at -18° C for 24 hours and dropped in specific orientations from a height of no less than 1.2 meters. No release of contents was observed and the passing criterion was met.
Leak resistance test - §173.197 Regulated medical waste (United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199)
Leak resistance was conducted by filling container to rated liquid capacity with water. The containers were then closed as per closing instructions and positioned upside down on cardboard paper to show any evidence of leaking. Contained upside down for 60 minutes while being observed for leakage. No leakage was observed and the passing criterion was met.
Stack test - §178.606 (c) (United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199)
Containers were filled to the required test capacity and closed as for shipment. Each container was subjected to a force applied to the top surface equivalent to the total weight of identical packages which might be stacked on it during transport. The minimum height of the stack, including the test sample, was 3 meters. Upon completion of the stack test, containers were observed for deformation. The containers did not deteriorate or release contents, and the passing criteria were met.
MAUSER USA. LLC. 2 Tower Center drive, 20th floor East Brunswick, NJ 08816 USA
Managing Director Hans-Peter Schaefer, CEO Registered Seat 50321 Brileh Local Court : Cologne Registration HBB 58469
info.us@mausergroup.com www.mausergroup.com
CONFIDENTIAL
6
Image /page/6/Picture/2 description: The image shows the word "MAUSER" in large, bold, blue letters. Above the "M" is a red triangle pointing downwards. The font is sans-serif and the overall design is simple and modern. It is likely a logo for the Mauser company.
MAUSER USA LLC, 2 Tower Center Drive 20th floor, East Brunswick, New Jersey 08816 USA Vibration test - §178.608 (United States Department of Transportation Code of Federal Regulations (CFR) Title 49, Transportation, Parts 100-199)
Containers were filled with simulated medical waste, closed as for shipment and placed on vibration table. The containers were then vibrated sing a vibration with a 1 in. vertical peak-to-peak displacement, for 60 minutes at a frequency that causes them to be raised enough such that a piece of material 1.6-mm thick can be passed between the container and the vibration platform. The containers did not rupture, leak or deteriorate, and the passing criteria were met.
Container Stability - ISO 23907 (Sharps Injury Protection - Requirements and test methods - Sharps Containers, First Edition 2012-09-01)
Container stability was evaluated by filling containers with a material of density 0.20+/-0.01 kg/l and placed on an incline with a minimum angle of 15°. Testing was conducted for each side of the container. The container did not slide or topple and the passing criteria were met.
Strength of Handles - ISO 23907 (Sharps Injury Protection - Requirements and test methods - Sharps Containers, First Edition 2012-09-01)
Handle strength was measured by filling container to 150% of its authorized gross mass and suspending it from handles for an hour at 23+/-5°C. The containers remained intact and handles did not rupture, tear. crack, or separate from the container and the passing criteria were met.
Clinical data were not submitted in this premarket notification
5.8 CONCLUSION
MAUSER PG II Sharps Container is substantially equivalent to Oak Ridge Products Sharps Container and Oak Ridge Products Multi-purpose Sharps Container (K130281 and K141759).
MAUSER USA. LLC 2 Tower Center drive, 20th floo East Brunswick, NJ 08816 USA Managing Director
Registered Seat 50321 Brüe Local Court : Cologne
7
Image /page/7/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2017
Mauzer Usa LLC Tatiana Smoleeva Sr. Associate, Technology & Regulatory Affairs 2 Tower Center Drive, 20th Floor East Brunswick, New Jersey 08816
Re: K170513
Trade/Device Name: Mauser PG II Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: September 25, 2017 Received: September 28, 2017
Dear Tatiana Smoleeva:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
8
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure