This manual incorporates changes required by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.

本手册合并了1990年医疗器械安全法案及1992年医疗器械修正案的修改要求。

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The comparable legislation that mandates user-fee waivers for small medical device companies, the Medical Device User Fee and Modernization Act (MDUFMA), specifies different criteria: Whether or not a company is small is determined by gross receipts or sales for the company and affiliates.

FORBES: Commentary

While the FDA regularly sends out warning letters to medical device and drug companies over design flaws or diverted and contaminated drugs, the SynchroMed case stands out because Medtronic is a known innovator in the medical device space, so it is surprising it would not act sooner to resolve the issue.

FORBES: Medtronic Sees Revenue Growth Despite Unaddressed Quality Concerns

We know medical device manufacturers will prosper under the new law -- the Affordable Care Act expands health insurance coverage to more than 30 million Americans and these newly insured individuals will use products made by the medical device industry.

WHITEHOUSE: Health Care Blog | The White House