Medical devices enforcement

Both CDER and CDRH will administer and, as appropriate, enforce the following activities for medical devices assigned to their respective Centers (References to Sections are the provisions of the Act) ... 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

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. 

But DSHEA is very different then the standard approval process for drugs and medical devices, and emphasizes the regulatory enforcement of label claims and advertising and marketing issues rather than the efficacy and quality of the supplements themselves. Unlike new drug and medical device applications, controlled clinical trials aren t part of the supplement review process, nor is any FDA inspection of a company s manufacturing facilities or quality control systems. 

During my tenure with the Center for Medical Devices, I was part of several injunctions that were referred to as corporate or corporatewide injunctions. These actions were intended to address what the agency believed to be a corporate culture that permitted, and possibly encouraged, company noncompliance. Corporate injunctions were invoked when compliance problems were found in different facilities of the same company. A pattern of noncompliance and negligence on behalf of the parent company led the agency to consider a corporate injunction as the regulatory enforcement tool. Corporate injunctions typically include the corporate parent, its senior officers, and all of its facilities around the world. It usually requires that some of those facilities cease operations for some period of time until compliance is achieved. Its characteristics are similar to the traditional injunction, with the exception that this particular enforcement targets the corporate umbrella. 

Enforce Laws and Regulations That Protect Health and Ensure Safety. This service involves full enforcement of sanitary codes, especially in the food industry full protection of drinking water supplies enforcement of clean air standards timely follow-up of hazards, preventable injuries, and exposure-related diseases identified in occupational and community settings monitoring quality of medical services (e.g., laboratory, nursing homes, and home health care) and timely review of new pharmacologic, biologic, and medical device applications. 

European medical device requirements are defined in EU Directive 93/42/EEC published in 1994. National legislation and regulatory authorities such as the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) enforce this directive. Four classes of device are defined, each of which requires a visible CE marking of conformity. CE marking of conformity means that the manufacturer is satisfied that the medical device conforms to relevant EU Directives and that it is fit for purpose. Technical documentation supporting conformity related to automated devices includes ... 

Over the years, the FTC s enforcement has been directed to a large extent at advertising for fringe products, such as medical devices sold directly to the consumer that promise dramatic weight loss or some other body enhancement. 

Health Canada is the responsible Ministry for the enforcement of the Food and Drugs Act and for the formulation of and amendments to the Drugs Regulations. The former Drugs Directorate and the Medical Devices Bureau of the Health Protection Branch (HPB) have been combined to form a new agency, the Therapeutic Products Programme (TPP). 

The six programmes that constitute the TTP are the Pharmaceutical Assessment responsible for premarket evaluation of drugs the Medical Devices Programme responsible for the administration and enforcement of the new medical devices regulations the Biologies and Radiopharmaceuticals Bureau Drug Surveillance Compliance and Enforcement and the Policy and Coordination Division. 

The LNCM s role is to control medicinal product quality, as well as the quality of body health products, cosmetics and medical devices for human or veterinary use. Furthermore, the LNCM ensures the enforcement of legislation and regulation inherent to the above mentioned products. 

In 1988, GMPs for medical devices were also enforced. A group of inspectors attached to pre-fectorial government perform regular on-site inspections of manufacturers, importers and distributors in order to check their compliance to GMP. 

FDA Enforcement Report Index. 1990-. Weekly. URL http // www.fda.gov/opacom/Enforce.html. This database provides access to drug and medical device recalls and product seizures in the United States. A search form incorporated into the opening page enables keyword searches of the entire collection. Simple queries involving only one factor, such as a company or brand name, quickly locate pertinent recall notices, each of which identifies specific product batches, quantities withdrawn from commerce, and their previous geographic distribution. Each entry also describes the reason for recall (contamination,... 

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