The days shorten but the potpourri stays strong, this week including information on the safety of FDA-cleared devices; medication adherence; genetic tests; the FDA and CMS working together to review products; state all-payer databases and the increasing control of physician practices by hospital systems.
The Food and Drug Administration has been reviewing its 510(k) process, which is used for many medical device approvals. Two preliminary reports contain a series of recommendations designed to provide greater predictability in the process, while ensuring identification of significant safety concerns.
Wireless or mobile communication technologies are enjoying a rapid spread in health care. Two of the primary federal agencies which might impact the development and spread of these technologies are the FCC and the FDA, which have agreed to work together in regulating them.
The Council for American Medical Innovation has released a report about the value of medical innovation to the United States’ economy. Concern is expressed about maintaining a vigorous medical product industry in the face of funding, reimbursement and regulatory challenges.
The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry. Mr. Roche is available to assist health care companies through consulting arrangements through Roche Consulting, LLC and may be reached at [email protected].
© 2024 Healthy Skeptic.
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