| Apr 15, 2025 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 5 cited references- 21 CFR 803.50(a)(2). Individual Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
- 21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
- 21 CFR 820.50(a). Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by suppliers have not been established.
| Official Action Indicated (OAI) |
| Oct 18, 2016 | Devices · Compliance: Devices | None posted | Voluntary Action Indicated (VAI) |
| Aug 26, 2016 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Apr 8, 2016 | Devices · Project Evaluation: Devices | None posted | No Action Indicated (NAI) |
| Aug 7, 2014 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Apr 18, 2014 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 1 cited reference- 21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
| Voluntary Action Indicated (VAI) |
| Sep 26, 2012 | Devices · Bioresearch Monitoring | None posted | Voluntary Action Indicated (VAI) |
| Apr 19, 2012 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 7 cited references- 21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
- 21 CFR 820.50(b). Supplier notification of changes There is no agreement with suppliers to notify you of changes in the product or service.
- 21 CFR 820.30(d). Design output - Lack of or inadequate procedures Procedures for design output have not been adequately established.
- 21 CFR 820.70(b). Production and Process Change Procedures, lack of or Inad. Procedures for changes to a specification, method, process, and procedure have not been adequately established.
- 21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device, labeling, and packaging to meet any of its specifications were not investigated where necessary.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
| Voluntary Action Indicated (VAI) |
| Nov 15, 2011 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 4 cited references- 21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
- 21 CFR 821.25(d). Notification of FDA re: non-compliant distributor FDA was not notified, nor were reasonable steps taken concerning a distributor who has not collected, maintained, or furnished any record or information required by the device tracking regulations.
- 21 CFR 820.30(g). Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.
- 21 CFR 820.25(b). Training records Personnel training is not documented.
| Voluntary Action Indicated (VAI) |
| Aug 18, 2011 | Devices · Bioresearch Monitoring | 1 cited reference- 21 CFR 812.140(b)(2). Sponsor device disposition records inadequate Records of disposition of a device which describe the batch number or code marks of any devices returned to the sponsor, repaired, and disposed of by the investigator or another person and the reasons for and method of disposition reports are not all accurate and complete.
| Voluntary Action Indicated (VAI) |
| Jun 7, 2011 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 5 cited references- 21 CFR 821.25(b). Records not current Current records for each tracked device while in distribution for use were not complete and up-to-date.
- 21 CFR 821.25(c)(3). Quality assurance procedures: 6-month & annual audits A quality assurance program that includes audit procedures for each device subject to tracking and audits performed at 6-month intervals for the first 3 years of distribution and annual audits thereafter using a statistically relevant sampling has not been established.
- 21 CFR 820.70(b). Production and Process Change Procedures, lack of or Inad. Procedures for changes to a procedure have not been adequately established.
- 21 CFR 820.30(j). Design history file The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
| Official Action Indicated (OAI) |
| Mar 18, 2011 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 7 cited references- 21 CFR 821.25(c)(3). Quality assurance procedures: 6-month & annual audits A quality assurance program that includes audit procedures for each device subject to tracking and audits performed at 6-month intervals for the first 3 years of distribution and annual audits thereafter using a statistically relevant sampling has not been followed.
- 21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 820.30(g). Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.
- 21 CFR 803.18(e). MDR not evaluated per 820.198 A submitted MDR event was not evaluated in accordance with the requirements of the regulations regarding Complaint Files.
- 21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
- 21 CFR 821.25(a). Written tracking program An adequate written device tracking program was not implemented for each device subject to a tracking order.
| Official Action Indicated (OAI) |
| Nov 12, 2010 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Mar 8, 2010 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 4 cited references- 21 CFR 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for the timely and effective identification of events that may be subject to medical device reporting requirements.
- 21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
- 21 CFR 820.100(a). Lack of or inadequate procedures The procedures for implementing corrective and preventive actions were not complete.
- 21 CFR 820.30(d). Essential design outputs Design outputs that are essential for the proper functioning of the device were not identified.
| Official Action Indicated (OAI) |
| Sep 14, 2009 | Devices · Compliance: Devices | 6 cited references- 21 CFR 820.100(a)(5). Implementing changes Corrective and preventive action procedures addressing implementation and recording of changes in methods and procedures to correct and prevent identified quality problems were not documented, complete, and implemented.
- 21 CFR 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for the timely and effective evaluation of events that may be subject to medical device reporting requirements.
- 21 CFR 820.100(a)(2). Investigation procedures The corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes, and the quality system were not implemented.
- 21 CFR 820.50(b). Supplier notification of changes There is no clear agreement from the suppliers that they will notify you of changes in the product or service.
- 21 CFR 820.30(g). Design validation - user needs and intended uses Design validation did not ensure that devices conform to defined user/patient needs and intended uses.
- 21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for identifying training needs were not implemented.
| Voluntary Action Indicated (VAI) |
Chelmsford, Massachusetts, United States. Part of