FDA Related News

Medical Devices

FDA Clears Myoscience Pain Device for Knee Osteoarthritis

FDA clears a Myoscience 510(k) for its iovera device for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days.

Federal Register

FDA Extends Comment Period in Intended Use Rule

Federal Register notice: FDA extends the comment period until 7/18 on a final rule that clarifies for drug and device manufacturers the agencys interp...

Medical Devices

AdvaMed Praises Bill Streamlining Some Device Approvals

AdvaMed praises legislation to allow some low- and moderate-risk Class 2 medical devices to be cleared based on objective criteria without having to b...

FDA General

House Health Subcommittee Advances User Fee Bill

The House Energy and Commerce Subcommittee on Health advances the FDA Reauthorization Act that would reauthorize user fee programs for five years begi...

Human Drugs

CDER Holding Preventable Harm Symposium

CDERs John Whyte says a 6/15 symposium will look at ways to reduce preventable medication errors.

Price Wants FDA Reviews 100% User Fee Supported

HHS secretary Tom Price calls on Congress to make all FDA medical product review activities 100% user fee supported.

Medical Devices

Some Magellan Lead Tests May be Inaccurate: FDA

FDA says some Magellan Diagnostics lead tests could yield inaccurate results when used with blood drawn from a vein.

FDA General

Researchers Find Moderate Trust in FDA

Researchers find that adults are more aware of FDA than adolescents, but adolescents trust the agency more than adults do.

Medical Devices

Dont Exempt Drug Assays from 510(k): Sharfstein

Former FDA principal deputy commissioner Joshua Sharfstein and other medical school professors say FDA should not exempt from premarket notification C...

Medical Devices

FDA Clears BrainCool Patient Temperature Cooling Device

FDA clears a BrainCool AB 510(k) for the IQool System, intended for use for temperature reduction in adult patients when clinically indicated.