Can anyone pls tell me if FDA has stayed the requirement for using FDA Form (Baseline Reporting)? The instructions for completing the. FDA FORM MEDICAL DEVICE REPORTING BASELINE REPORT. Find the most up-to-date version of FDA FORM at Engineering
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The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force GHTF was conceived in by five members: All regulated countries have clearly defined medical devices, as has the GHTF.
Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF.
Further, regulated countries have classified medical devices on the basis of their associated risk. In the Fprm regulatory system, medical devices are still considered as forrm. In addition, medical devices are not classified by any Indian regulatory authority.
Although India has moved towards harmonizing its medical device fva with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.
European Union, United States, Australia, Japan, and Canada wherein the vigilance of devices was among the study groups. All regulated countries have distinctly defined medical devices, but GHTF defined a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, which is thereby intended to be used by the cda for human beings for one or more of the specific purposes of: The Medicines and Healthcare products Regulatory Agency MHRA 9 has excluded materials used for disinfecting medical devices from the definition, whereas the Therapeutic Goods and Administration TGA 3 has excluded tampons and hospital, household, and commercial grade disinfectants.
However, to date, India has considered medical devices as drugs. This study forn the result of the examination and comparison of regulations to monitor medical devices in national regulatory authorities: The issue of whether India should establish a vigilance system in harmony with those of the GHTF members or start with a clean slate was also taken into account.
Hence, the study was initiated to examine the proposed framework, and its implication, for the Indian medical device vigilance system with respect to global harmonization, ie, GHTF. During this study, the information was collected through secondary media, ie, the official Websites of the respective regulatory authorities and the knowledge gained by interaction with various industrial professionals in the field of regulatory affairs. In the Indian regulatory system, medical devices are considered as drugs by the Ministry of Health and Family Welfare.
It declared 10 devices, such as cardiac stents, drug-eluting stents, catheters, intraocular lenses, bone cements, heart valves, scalp vein sets, and so on, corm be considered drugs and included another 19 sterile medical devices on March 20, [on hold] such as extension tubes, arterial venous fistulas and spinal needles, ofrm measuring sets, heart lung packs, and so on, under the provisions as such.
Inthe Medical Device Regulation Bill 12 was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India for establishing and maintaining a national system of controls relating to quality, safety, efficacy, and availability of medical devices that are used in India, whether produced in India or elsewhere and exported from India. It was recommended that the provisions of this Act should come into force by December 31,but the bill was not passed by the Rajya Sabha and and the bill was abolished.
It was expected that a definition of medical devices and other likely changes shall be incorporated in Schedule M III by With the initiation of such amendments, it was addressed to include medical device with the Drugs and Cosmetics Act and Rules in a recent press release from the Medical Device Regulatory Authority of India. It has been working closely with the Central Drug Standard Control Organization CDSCO and Indian medical regulators both importer and native manufacturers to increase access to medical device, promoting its manufacturing and streamlining the regulatory process toward global harmonization.
If the product is being imported to India, the importer has to submit postmarket surveillance data including protocol and report not exceeding 5 years for the following: However, the requirements specified do not require the manufacturer to provide the data for a specified period, but the manufacturers have been required to submit postmarket surveillance data for at least a period of 3—5 years.
Each regulatory authority has classified medical devices in its own way.
In general, the basis for medical device classification is: The US Food and Drug Administration FDA 17 has classified medical devices into three classes on the basis of level of control necessary to assure the safety and effectiveness of the device and on the basis of information about marketing requirements and has grouped them into 16 medical specialties:.
The TGA 18 has classified medical devices into five classes on the basis of set of four classification rules: Likewise, the MHRA 4519 has classified medical devices into three groups:. The general medical devices were then further classified into four classes as described in Table 1. Also, the MHRA classified medical devices within a series of 18 rules depending on functions, parts foem body treated, and properties of medical devices. If more than one rule applies to a medical device, the higher would be its classification.
In comparison to the fotm countries, medical devices in India are not classified on the basis of risk. Rather, the device category of medical devices has been notified to be regulated as drugs. Once the medical devices are marketed, they must be tracked up to the end-user for the useful life of the device to facilitate patient notification or recall at the time of any defect or problem with the device.
The FDA 220 — 23 has included medical device tracking as one of its postmarket surveillance activities, but tracking is still in the development stage for inclusion in the TGA vigilance system. The devices require tracking if they meet statutory requirements according to the FDA act and if the FDA has issued a tracking order.
It has also listed some implantable devices that are subjected to tracking. Furthermore, it requires submission of tracking information fotm the manufacturer, distributor, and user facility.
The manufacturer must provide critical information about the devices within 3 or 10 days if a device has not or has been distributed to a patient, respectively. The written records for the useful life of device must also be maintained by the manufacturer and the distributor. Each incident is given an AITS reference number, and the risk associated with the device is assessed. The adverse incident is then accordingly allocated into one of the five investigation categories, ie, urgent in depth, in depth, standard, information, and others.
It is the responsibility of manufacturer or authorized representative to track incident reports, but the information to be tracked is not being specified. In-depth investigations lead to the issue of a Medical Device Alert, whereas standard investigations are initially conducted via a series of standardized letters issued directly by the adverse incident center.
In India, the labeling provisions for devices include identification of lot number or batch number for easy traceability of the device, but maintenance of the tracking records by the manufacturer is not a mandatory requirement. However, in a recent press release by the FICCI, 13 the Health Minister Dinesh Trivedi had promised to set up a National Health Portal for sharing information in the public domain on standardization and protocols and to ensure that the medical records of all citizens are electronically stored for ease of access by pathologists and doctors for diagnosis and treatment of patients.
The statement seemed to represent promising progress toward the establishment of a tracking portal for medical devices. The adverse event reporting system has been considered as a tool to improve and protect the health and safety of patients and users, thereby reducing the likelihood of adverse events, to prevent repetition of adverse events, or to alleviate consequences of such repetition. Despite the steps taken by the GHTF to achieve uniformity among adverse event reporting systems, the system still differs in founding member countries.
The GHTF 27 provided the guidance on mandatory reporting of adverse events for device manufacturers and voluntary reporting for users. Also, the manufacturer must decide the reportability of adverse events on the basis of information available. The regulations do not require foreign manufacturer to meet FDA regulations, but if employed, the agent could forward reports and will be viewed as an employee of a foreign firm.
The TGA 2432 has encouraged the reporting of adverse events not only by the manufacturers and sponsors but also by users. The EEC 93334 directives include requirements not only for manufacturers or authorized representatives of medical device to report certain types of incidents to a competent authority such as the MHRA, but also for the MHRA to disseminate the information to other competent authorities and the EEC.
However, the FDA 28 — 31 also requires the manufacturer to report malfunctions and events occurring due to user errors. The TGA 2432 also requires the sponsor or manufacturer to report malfunctions. In addition to the above reporting criteria, a manufacturer in India 15 must also report events that do not require to be reported under regulations, so that trends or patterns of their occurrence can be monitored.
The regulated countries, along with India, 15 defined not-reportable events similarly with few exceptions.
The following events 27 — 45 are exempted from reporting in all countries:. As mentioned above, the manufacturer is required to report adverse events occurring in Australia 2432 and 33417 if they occur after the issuance of an advisory foorm, and their occurrence and frequency are submitted with the annual report, whereas in the United States, 35 the manufacturer can request remedial action exemption RAE with or after the submission of one fa more 5-day or day initial reports on events.
The RAE can be requested if the information received is erroneous; the forrm does not result in death, serious injury, or other adverse events; death or serious injury did not occur; and another manufacturer has made the device. Although the reportability of the adverse event is uncertain, the GHTF 2745 requires immediate reporting by the manufacturer of unanticipated death, serious injury, or public health threat and all other reportable events as soon as possible, but no later than 30 elapsed calendar days following the date of awareness of the event.
Medical device vigilance systems: India, US, UK, and Australia
Also, if the adverse events are reported within the first 2 weeks based on an incomplete investigation, it may require a subsequent follow-up report. The FDA 28 — 31 requires reporting of events not only by the manufacturer, whether domestic or foreign, but also by the user facility and distributor.
The manufacturer must submit four reports depending on the event reported: The user facility and distributor need to report death and serious injury within 10 working days on FDA form A.
The user facility is also required to submit semi-annual reports to FDA form from January 1 to July 1. Eventually, form A should report events for each device, and only one report must be submitted for the same patient or same event irrespective of the multiple sources of information for an event.
Voluntary reports may be submitted at any time for adverse events, product problems, and product use errors through completion of online MedWatch FDA form In Australia, 2432 although it is the manufacturer who must assess an incident, the sponsor is held accountable for forwarding information about events to the manufacturer and then for forwarding the results of any analysis to the TGA.
Hence, the reporting time frame for reporting adverse events is as follows:. In certain cases, if all information is not available, the sponsor or manufacturer must provide it later when it is, as additional information along with a statement to the effect that the report is made by the manufacturer and sponsor without prejudice and does not imply any admission of liability for the incident or its consequences.
All reports should be submitted to the Coordinator of the Medical Device. In United Kingdom, 3334 the manufacturer is required to report within the time frame relating to the type of incident upon becoming aware that an event has occurred and one of its devices has caused or contributed to the incident, ie. If the report is made orally, it should be followed by a written report as soon as possible and a statement to the effect that the report is made by the manufacturer without prejudice and does not imply any admission of liability for the incident or its applicability.
The manufacturer or authorized representative must submit an initial incident report to MHRA for record and evaluation, followed by final reports, which should not be delayed by incomplete information. According to the recent amendments directed by the CDSCO, 15 the manufacturer is liable to report unanticipated death or serious injury or a serious public health threat within 10 days of becoming aware of the event, and all other reportable events not later than 30 elapsed calendar days.
Because of the uncertainty of the reportable events, the manufacturer must report within the expected time frame. The reports being submitted are determined on the grounds of stipulated reporting time frames. Thus, GHTF 2745 has not recommended any report types for manufacturers. The type of report to be submitted differs among the regulated countries, as the reporting time frame differs. However in United Kingdom, 3334 the manufacturer or authorized representative can report incidents by submission of following reports:.
All device complaints, potential use error events, and abnormal use events must be reported and investigated by the manufacturer. The manufacturer must perform the investigation after the initial report in consultation with the user while informing the MHRA of the progress through periodic reports or trend reports as appropriate.
If initial assessment involves an alteration of the device that might affect subsequent analysis, the MHRA must be informed before proceeding with alteration. The choice of report type depends on the availability of applicable data within the appropriate report time.
The dissemination of information among the National Competent Authorities NCAs can help to improve the health and safety of patients, users, and others by reducing the likelihood of repeated similar adverse events. The necessity for NCAR exchange would depend on the seriousness of the incident associated with the device and its extent of global distribution. The criteria for NCAR exchange are as follows:. However, the FDA does not specify a vigilance exchange program as one of its postmarket activities.
In Australia, 2432 the NCAR program is obliged to exchange vigilance information with overseas regulatory agencies through its participation in the GHTF and various mutual recognition agreements. Consequently, the information will be exchanged on incidents and events for which corrective action, including recalls, is to be taken and there is a serious risk to the safety of patients or other users, but where no corrective action has yet been established, although measures are under consideration, or where there is not yet a final report from the sponsor.
In spite of communicating the information to the public, it is recommended to communicate notification directly to the medical practitioner or health professional, unless required.
Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent to the quality of the final product. Manufacturers are required to establish and maintain written procedures for implementation of the MDR regulation, including the following:.
The records related to an event whether reportable or not must be maintained for 2 years from the date of the event or a period equivalent to the expected life of the device, whichever is longer.
The sponsors marketing medical devices in Australia are required to keep distribution records and retain them for 5 years after the last product has been made and to provide the records, or copies of the records, when requested by the TGA.