Device oversight

Figure 2.8 Milestones in the development of regulatory oversight of drugs and devices in the USA.

Market Vigilance and Oversight of Devices 263 Table 12.3 Su mmary of periodic reporting obligations in the US. 

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. 

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. )... 

The FDA considers LDTs medical devices subject to FDA regulatory oversight, but witli very few exceptions has not executed this authority the high complexity laboratories that develop LDTs are regulated by the Center for Medicare and Medicaid Services under the provisions of the Chnicai Laboratory Improvement Act [CLIA] of 1988). With the ASR category, the FDA shifted its focus from the laboratory to the manufacturers of reagents, and proposed controls and restrictions to ensure their quality and consistency, and to clarify that a laboratory setting up these tests is responsible for the tests performance. 

Physicians exercise plenary independent prescribing authority. Plenary authority refers to the ability to prescribe all drugs, treatments, and devices, including controlled substances, without supervision, control, or oversight by another profession.Independent prescribing authority means that the prescriber has the sole authority to make treatment decisions and is wholly responsible for the resultant outcomes. 

Regulatory oversight of products that combine a drug and a device require coordination within the FDA divisions responsible for each aspect of the product. This causes increased difficulty for the sponsor company in determining who is primarily responsible for the review of their application. The sponsor finds themselves in a position of encouraging the two Centers reviewers within the FDA to communicate and share information on their review and the status of their review. Reviews that involve coordination between FDA Review Divisions and reviewers who do not usually work together can add significant time to the FDA review and approval process. 

On the national level, oversight is generally restricted to medical devices, and not on operational matters. Federal jurisdiction of medical devices falls under the purview of the Department of Health and Human Services, Public Health Service, Food and Drug Administration (FDA), Center for Devices and Radiological Health. Under federal law, medical devices are regulated under the Medical Device Amendments of 1976 and the Radiation Control for Health and Safety Act of 1968. Additional regulatory authorization is provided by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, the FDA Reform and Enhancement Act of 1996, and the Food and Drug Administration Modernization Act of 1997. ... 

The major thrust of the FDA has been in the oversight of the manufacture of medical devices, with specific requirements based on categories of perceived risks. The 1976 Act (Section 513) estabhshes three classes of medical devices intended for human use ... 

The collision was not caused by a random hardware failure, nor was it simply an error or oversight on the part of the persons performing the work. Instead there was a systematic culture of not conducting wire counts on devices, an action which would have revealed the rogue... 

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