Public Health Effectiveness of the FDA 510(k) Clearance Process Balancing Patient Safety and Innovation: Workshop Report (2010) / Chapter Skim
Currently Skimming:
6 Public Comments
6 Public Comments
Pages 53-62
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 53... ...
, which has more than 17,000 board-certified orthopedic surgeons as members, emphasized the role of surgeons in promoting patient safety through the responsible use of implantable medical devices, reporting of adverse events, and postimplantation reviews of patient outcomes. Failures occur and can have devastating effects on patients, but they rarely happen as the result of a single factor that could have been readily identified through premarket studies.
|
From page 54... ...
If the data suggest systemic failures or isolated pockets of products that need additional scrutiny, MDMA is willing to address them and to make sure that the appropriate special controls or remedies are in place. But it is necessary for the data to demonstrate that
|
From page 55... ...
Patient safety is the number 1 priority of the medical device technology industry, but any regulatory requirement should balance FDA's dual mission of protecting the public health and facilitating innovations that benefit patients. Since the 510(k)
|
From page 56... ...
The 510(k) application has several key components, including the device description; intended-use statement; predicate-device comparison; declaration of conformity to performance standards and mechanical and safety standards; general clinical safety and effectiveness; clinical data, if applicable; device hazard analysis; software description; cleaning, disinfec
|
From page 57... ...
process in terms of device features (for example, display of fluoroscopic radiation time for fluoroscopy, acoustic output display for ultrasonography devices, and automatic exposure controls and audible signals to indicate duration and termination of exposure to x-rays)
|
From page 58... ...
model for assessing risk with the documentation that must be submitted for agency review on the basis of that risk. This would mean submitting the same kind of information that is provided in the de novo process but without having to go through the first step of getting the NSE turndown and then resubmitting information to the agency.
|
From page 59... ...
A medical device submission consultant provided the committee with a report in which he identifies two root causes of the current problems in the 510(k) system: lack of a process for determining what data are necessary to demonstrate device safety and effectiveness and the dysfunctional requirement to demonstrate substantial equivalence to a specific, legally marketed predicate device to determine, according to risk, whether a new medical device is in class I, II, or III.
|
From page 60... ...
The organization noted among its accomplish ments its successful urging of FDA to issue a public-health notification warning of the serious risk poses by and complications of the transvaginal placement of synthetic surgical mesh. The warning was issued to health-care practitioners in October 2008.
|
From page 61... ...
The organization specifically recommended that the committee consider the following changes in the 510(k) clearance process: • Educate the American public about the difference between premarket approval and premarket notification.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.