The Food and Drug Administration (FDA) is responsible for regulating the safety and proper labeling of foods, medicines, medical devices, veterinary drugs, animal feed, cosmetics, vaccines, and blood products. Listed below you will find some information on how the reporting system works and on what manufacturers and healthcare facilities are required to do.

1. The FDA requires any medical equipment manufacturer to report any complaints of malfunctions, serious injuries or deaths caused by a certain piece of equipment. These regulations are included in the Medical Device Report (MDR) released in 1984 and updated in 1996 and 1998.

2. The main purpose of MDR has been to provide an efficient mechanism through which both the FDA and medical manufacturers can monitor adverse effects related to medical devices. In this way, the FDA intends to more rapidly detect when a problem arises so as to promptly correct it, before more serious incidents occur.

3. Reports can be submitted not only by medical device manufacturers and distributors, but also by the users of the devices. Device user facilities include hospitals, ambulance providers, outpatient treatment facilities, rescue services, and nursing homes. Even patients and families of patient have the ability to send a report to the FDA, on their official website. Nonetheless, private medical practitioners are not considered to be device user facilities.

4. The format and the information contained in the report depend on whether it is being submitted by the device user and distributor or by the device manufacturer. Device users and distributors have to submit info about the patient, the type of event, relevant medical records, the manufacturer’s name and contact details.

5. Reports sent in by device manufacturers contain more detailed information about the device, methods through which the equipment was evaluated as well as any actions taken to correct the situation.

6. Foreign device manufacturers that operate within the United States are required to designate an agent in the country that will take on the responsibility of sending reports to the Administration. The agent, which first has to register with the FDA, will have to follow the same regulations as all medical device manufacturers in the US.

7. Certain individuals are exempt from the obligation to report to the FDA. These individuals include practitioners who manufacture or purchase devices for the treatment of their own patients alone, persons who manufacture devices only for their personal research or study, and dental and optical laboratories.

8. Additionally, the FDA can also choose to grant certain exemption from reporting, upon a written request or even at its own discretion. Apart from exemptions, the Administration also has the power to grant manufacturers alternative forms of reporting, to change the frequency of reporting or to change the requirements.

FDA reporting for safer medical products may be a little tricky to understand at first but it is important for healthcare facilities, medical device manufacturers and distributors to be aware of it. The information presented above represents the most important aspects involved in submitting a report to the FDA regarding the safety of a medical product.

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Category: Medical Business
Keywords: FDA Reporting for Safer Medical Products,Medical device manufacturers,healthcare facilities