Medical Devices Authority

Congress expanded FDA s authority in 1962 with the Dmg Amendments of 1962, which stipulated that, before a dmg could be marketed, it must be shown to be effective as well as safe. In 1976, Congress similarly expanded FDA s authority over medical devices with the Medical Device Amendments. 

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

As described previously, persons responsible for placing medical devices on the EU market are only required to notify the Competent Authority in the state where... 

The responsibilities of Competent Authorities in terms of market vigilance are set out in the Articles of the device directives, whereas the obligations for manufacturers are contained in the Armexes. MEDDEV guide 2.12-1 provides detailed practical guidance on how the medical device vigilance system should operate within the EU, the European Economic Area (EEA) and Switzerland. This guidance was significantly... 

Sub mission of this report does not. in itself, represent a oonclusion ty the manufacturer and/or authorized representative or fhe nalional comyjefeni aufiiorfiy that the content of this report is compiete or accurate, that the medics/ device(s) listed failed in any manner and/or that the medics/ devieefsf caused or conrnbuled to the alleged death or deterioration in the state ot the health ot any person,... 

The Competent Authority to which the incident was originally reported usually takes on the role of monitoring and evaluating how the incident is dealt with. When all actions are complete, including any necessary Field Safety Correction Actions, the manufacturer must submit a final report to the Competent Authority. Under a safeguard clause. Competent Authorities may take unilateral action to remove a device from their market, if they believe that it poses an unacceptable health risk, but the Commission must be informed of such actions. In less-urgent situations, concerns may be referred to the Committee for Medical Devices for consideration. 

Active Implantable Medical Devices Directive 90/385 EEC Article 8 (Competent Authority Vigilance procedure), Annex II 3.1 (manufacturer s vigilance and reporting duties)... 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

The shares for categories 7 and 9 were given with less thanl% and adjusted to 0.5%. Category 8 (medical devices) has been left out by the authors of the WEEEman maybe because of its minor importance. 

Safe Medical Device Act, providing additional authority to the FDA for regulation of medical devices. 

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. 

New Zealand Medicines and Medical Devices Safety Authority... 

One court has interpreted the FD C Act as not authorising FDA to require restitution by a manufacturer to purchasers of a product that has been found to violate the FD C Act, but a more recent court decision has upheld restitution. The Medical Device Amendments of 1976 explicitly provide such authority for medical devices. ... 

In Japan, prior to 1979 no formal regulatory guidance was available to western pharmaceutical companies and a marketing authorization of new drug products could not be obtained by non-Japanese manufacturers. The PMDA as we know it today was established in 2004 from the earlier Pharmaceutical and Medical Devices Evaluation Centre (PMDEC), the Organisation for Pharmaceutical Safety and Research (OPSR), and the Japanese Association for the Advancement of Medical Equipment (JAAME). 

Studies conducted by different authors on the release of chemical substances from medical devices, mainly those used for infusing solutions, show that these are potential sources of contamination for pharmaceutical formulations. One of the most studied is diethylhexyl phthalate, the same plasticizer found in PVC infusion bags to give flexibility. The same concerns about the use of PVC bags for the storage of lipids or lipophilic formulations are valid for tubing. 

Software Validation Authorities are demanding rules in order to outline the software validation principles used in medical device software or the validation of software used to design, develop, or manufacture medical devices. 

The FDA has authority over clinical trials for drug, biologic, and medical device products regulated by the agency. This authority includes studies that are HHS-funded (with joint oversight by the FDA and the OHRP), as well as studies that are solely funded by industry or by private parties. Many clinical trials are not subject to FDA regulation but are monitored by the institution sponsoring the trial, such as a hospital. (See Institutional Review Boards. )... 

In this definition, the key words are documentation, specific process, product specifications, and quality. This automatically means that validation will play a vital role in guaranteeing the safety, identity, quality, and stability of all pharmaceutical, biological, and medical device products. We will now present an outline of the most important requirements for ensuring that packaging line equipment complies with the guidelines of the authorities. 

The guarantee of conformity to the essential requirements of the MDD is provided by the interaction between the manufacturer and a third party, the notified body. The notified bodies are organizations that are recognized by the member states to conduct device evaluations and inspections of the quality systems of the various manufacturers. The manufacturers are held responsible for the quality, safety, and effectiveness of their medical devices. This is enforced through the manufacturer s written declaration of conformity and commitment to keep all technical information available for inspection by the notified bodies and national authorities. 

Regulatory authorities strictly scrutinize the leachables (e.g., plasticizers, impurities) that may come from medical devices and drugs. It is the responsibility of the drug or medical device company to identify the leachables and to provide adequate testing of their toxicity. Monitoring methods must be developed and validated to effectively control toxic leachables during the manufacture of high quality pharmaceuticals. 

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