International Medical Device Regulatory Monitor

While judging the Medicines and Healthcare products Regulatory Agency’s (MHRA) response to the PIP silicone breast implant scandal basically sound, a new review by the UK Department of Health (DOH) finds the agency needs better access to information on devices to preclude similar safety scares in the future.

Manufacturers hoping the U.S. Food and Drug Administration (FDA) might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report. Includes the full text of U.S. FDA Report on Devices Approved in the EU but Not in the U.S.

Makers of x-ray imaging devices would need to take special steps to ensure their products perform safely and effectively when used on children, under a U.S. Food and Drug Administration (FDA) draft guidance issued May 10.

The Association of the Heads of the European Radiological protection Competent Authorities (HERCA) and the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) have signed a memorandum of understanding (MOU) to promote radiation protection initiatives.

Implementing a new labeling requirement by the EU’s Central Management Committee (CMC) on Medical Devices will raise devicemakers’ costs without any benefit to patient safety, industry association Eucomed says.

Medical devicemakers who advertise their products in Australia’s mainstream and specified media would be required to get their advertisements preapproved, under a Therapeutic Goods Administration (TGA) proposal to extend a system currently limited to nonprescription drugs.

South Africa’s draft device regulations have been “significantly revised” following last year’s public consultation and could be approved this year, a Department of Health (DOH) official tells IMDRM.

Devicemakers doing business in Malaysia must register their products, beginning in November, a Medical Devices Control Division (MDCD) official confirmed to IMDRM.

The Global Harmonization Task Force’s (GHTF) Study Group 1 has modified its definition of a medical device and provided an explicit definition for the term in vitro diagnostic (IVD) medical device, according to a final document released May 16.

The U.S. Food and Drug Administration (FDA) may need to better match its regulations with those of key trading partners, a move that could benefit the increasingly global device industry, thanks to a new executive order (EO), 13609, signed by President Barack Obama May 1.

Medical devicemakers, drug companies and some local government officials are urging Health Canada to expand its Summary Basis of Decision (SBD) initiative so product approval reports are published more quickly and on a wider range of products.

The U.S. Federal Communications Commission (FCC) on May 24 adopted rules broadening the spectrum available to medical devices and expanding the horizon for innovative wireless technologies and applications.

The U.S. Office of Management and Budget (OMB) could release the Food and Drug Administration’s (FDA) proposed rule on a unique device identification (UDI) system “any day now,” an agency official says, ending a nearly year-long delay in finalizing the much-anticipated safety mechanism.

The U.S. Senate voted 96-1 on May 24 to approve an omnibus Food and Drug Administration (FDA) user fee bill, but earlier rejected an industry-backed amendment to repeal the upcoming medical device excise tax.

As devicemakers work with increasing numbers of suppliers, their risks of liability rise, making it imperative they have contracts and auditing policies in place to avoid costly lawsuits, recalls and adverse publicity, a product liability expert says.