Medical Device Reporting requirements

Surgical sutures are sterile, flexible strands used to close wounds or to tie off tubular structures such as blood vessels. Made of natural or synthetic fiber and usually attached to a needle, they are available ia monofilament or multifilament forms. Sutures are classified by the United States Pharmacopeia (USP) (1) as either absorbable or nonabsorbable. The USP also categorizes sutures according to size (diameter) and Hsts certain performance requirements. Sutures are regulated by the Food and Dmg Administration (FDA) as medical devices under the Food, Dmg, and Cosmetics (FDC) Act of 1938, the Medical Device Act of 1976, and the Medical Device Reporting regulation of 1995. 

The requirements for market vigilance and oversight in the US are set out in 21 CFR 803, Medical Device Reporting, 21 CFR 806, Reports of Corrections and Removals and 21 CFR 822 Post market Surveillance. 

Table 12.4 Summa of Medical Device Reporting (MDR) requirements for individual adverse incidents.

E. Medical Device Reporting. The manufacturers, distributors, importers, and users of all devices, including those regulated by CDER, shall report to CDRH under Section 519 of the Act as required. The Center for Devices and Radiological Health will provide monthly reports and special reports as needed to CDER for investigation and follow-up of those medical devices regulated by CDER. 

The Safe Medical Devices Act requires reporting of medical devices that probably caused the death, serious filness, or injury of a patient. Postmarket surveillance on permanently implanted devices required with methods for tracing and locating patients depending on such devices. FDA is authorized to recall device product. 

The Equivalent of a Development Report for Medical Devices in the Design History File. This comprehensive file would include critical information about the device s design, changes, review, and design controls. For medical devices, the requirements for the device s history have been codified under 21CFR 820.30. 

In accordance with 21 CFR 814.84(a), you must also comply with Medical Device Reporting (MDR) requirements, 21 CFR Part 803, and any requirements made applicable by other regulations or by order approving the device, including the following. 

Nursing homes, hospitals, and other facilities that utilize medical devices were required to report to the FDA information arising out of medical devices that contributed to the death or serious injury of a patient. The FDA acquired the authority to order device recalls. Manufacturers of devices were required to conduct post-market surveillance on all permanently implanted devices whose failure might cause serious harm or death. 

Adverse Events. The Safe Medical Devices Act of 1990 included a provision by which both users and manufacturers (and distributors) of medical devices are required to report adverse patient events that may be related to a medical device. Manufacturers must report to the FDA if a device (a) may have caused or contributed to a death or serious injury, or (b) malfunctioned in such a way as would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur. Device users are required to notify the device manufacturer of reportable incidents, and must also notify the FDA in case of a device-related death. In addition, the FDA established a voluntary program for reporting device problems that may not have caused an untoward patient event, but which may have the potential for such an occurrence under altered circumstances. 

The pharmacist or physician can report any problems experienced with dmg products and medical devices. In cases where the PDA and/or manufacturer finds that a marketed product constitutes an actual or potential threat to the safety and welfare of the pubhc, that product must be withdrawn from the marketplace, ie, recalled. Several classes of recalls exist, depending on the relative danger that the product exhibits. C/ass I dmgs pose a serious health threat and may require withdrawal at the consumer level C/ass II dmgs pose a possible or potential health problem that usually means withdrawal at the pharmacy or wholesaler levels and C/ass III dmgs may present a remote hazard to health and safety. 

Class 1 medical devices, which include some simple IVDs, are usually exempt from the premarket section 510(k) application process, and their manufacturers are only required to register and list, follow good manufacturing practices, and report device failures. As experience develops with a given medical device it can be reclassified downward from class 3 to class 2 and eventually to class 1. 

All adverse events with medical devices of which the manufacturer becomes aware must be recorded. The detailed legal requirements in relation to recording and reporting are, curiously, more onerous in relation to MDs than AIMDs. However, the Commission s guidance is that they should be treated the same in practice. In general, a manufacturer of general medical devices should report, and a Member State record and evaluate,... 

Dr Yoshinobu Hirayama, Director, Evaluation Division 1, of the MHW Pharmaceuticals and Medical Devices Evaluation Centre confirmed that the current GAIYO (Expert Report) will be replaced by CTD Module II documents. He cautioned, however, that although the CTD provides a common content and format, there will be cases where differences would necessarily occur in dossiers for the three regions (e.g. there may be different dosage recommendations and different quality requirements). He sympathised its the impact on industry who would feel the burden of transition more than regulators and indicated that the transition time before the CTD... 

It is very important to ensure that having a signed paper-based record (e.g., a report) associated with one or more electronic records, the electronic file(s) associated with these records must not be deleted. The Part 11 regulation is very specific regarding this issue. Electronic files in hybrid systems must be maintained electronically. The interpretation of this requirement in the medical devices CGMP regulations (21 CFR 820) is different. Part 820 requires that the results of acceptance activities are recorded, but are not necessarily raw data, and these results must have audit trails. This interpretation is contained in the medical device quality system preamble (pp. 52631 and 52646). 

The submission of an application conveys an acceptance of certain responsibilities, including the accuracy and the quality of the data as well as the required subsequent reporting and technical commitments for the product and its intended use. To assure the accuracy and quality of the data and information provided in applications, the Act gives the FDA broad authority to inspect pharmaceutical and medical device establishments, including manufacturers and other research testing facilities from which data are derived. Applicants therefore must have documented systems in place for all processes from which data are derived and included... 

The FDA Critical Path Opportunities Report [2] recognizes that there is a need for better animal disease or tissue injury models that could provide more accurate predictions of the toxicity of drugs, devices, and biological products that are used in ill or injured patients. Use of such models could also enhance our understanding of the potential toxic effects of compounds associated with many types of medical devices. It is important to note that the regulatory authorities will always require solid scientific justification for the use of these animal models for disease to support safety. 

---