April 2012 Posts

FDA Gets an Extra $10 Million for China

Mark Crawford

At the end of April the U.S. Senate approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA, including $10 million to fund an expansion of the agency’s China office.

The Transforming Food Safety and Protecting Patients Initiatives within the bill provide $10 million in new resources for the FDA to improve collaboration with Chinese inspectors and increase the FDA’s presence in and expertise on China. (more…)

Nanotechnology and the FDA

Nanotechnology and the FDA

Mark Crawford

In June 2011 the FDA issued draft guidance for industry entitled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.” Building on the recommendations within that document, the agency released two new nanotechnology-related guidances in April: (more…)

Thinking about Brazil? Here’s what You Need to Know

Thinking about Brazil? Here’s what You Need to Know

Mark Crawford

If you aren’t already there, maybe you should think about Brazil.

With a population of about 200 million, Brazil is one of the largest medical-device markets in the world. It has a well-developed, evolving, and fairly reasonable regulatory system in place that is similar in many ways to the EU (although it has some significant differences, too). (more…)

Pilot Program for ISO 13485 Audits Sounds Promising

Pilot Program for ISO 13485 Audits Sounds Promising

Mark Crawford

On March 19, the FDA announced guidance for a medical device ISO 13485:2003 voluntary audit report submission program. The document provides a strategy for responding to Section 228 of the Food and Drug Administration Amendments Act of 2007, which states that:

“For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.” (more…)