International Medical Device Regulatory Monitor

The medtech industry is calling for an end to “imitation” health technology assessments (HTAs) for medical devices.

The Belgian Health Care Knowledge Centre’s scathing review of the European Union’s premarket evaluations contains significant misconceptions, the European medical technology industry says.

Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) seeks companies interested in acting as third-party reviewers for medical devices. Includes the full text of CoFePrIS’ Call for Third-Party Medical Device Reviewers.

Health Canada (HC) is incorporating risk-based reviews into its facility inspections. Includes the full text of Health Canada’s Risk Based Inspection Cycle.

Devicemakers preparing “Section 522” postmarket surveillance study plans should include a regulatory history, brief description of the device, indications for use and purpose of the study, according to a new draft guidance from the U.S. Food and Drug Administration (FDA).

To illustrate how reviewers analyze device applications and make their recommendations for approval, a new U.S. Food and Drug Administration (FDA) draft guidance distills benefit-risk analysis of devices into a series of topics and questions and offers a worksheet on key considerations.

Requests for enhanced adverse event reporting have spurred Australia’s Therapeutic Goods Administration (TGA) to promise new online reporting forms for medical devices.

New legislation in Brazil gives domestic medical devicemakers preference in public supply tenders, leaving foreign companies concerned for their prospects in the country.

A memorandum from the Italian Ministry of Health outlines new procedures for applying to conduct device clinical trials.

Recommendations on subject and endpoint selection and minimizing bias dominate a new U.S. Food and Drug Administration (FDA) guidance on device clinical study designs.

The U.S. Food and Drug Administration (FDA) has again amended special controls for Herpes Simplex Virus (HSV) Types 1 and 2 Serological Assays.

The European Commission’s Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices clarifies contact lens classification.

In individuals, ionizing radiation used in medical imaging poses a small risk of cancer, but statistically radiation can be a significant hazard, according to a new report.

Facebook no longer will allow drug- and devicemakers to disable the capability to post comments, including adverse event descriptions, on community-focused Facebook pages.

A U.S. Food and Drug Administration (FDA) nanotechnology guidance is useless because it’s vague, provides no new information and doesn’t pay adequate attention to international standards companies already use, devicemakers say in comments on the draft.

More and better use of devices and diagnostics as countermeasures in the global war against terror are among goals the U.S. Food and Drug Administration (FDA) describes in a crosscutting strategic plan to advance regulatory science in and out of the agency.