International Medical Device Regulatory Monitor

Taking a device to Europe to gain quicker access to market compared with the U.S. Food & Drug Administration (FDA) review mechanism is a short-term fix, not the solution to maintaining the pace of industry innovation.

After months of complaints by devicemakers and Congress that the EU system is superior to its U.S. counterpart because products get to the market faster in Europe, the U.S. Food and Drug Administration (FDA) is looking to European doctors for validation.

South Africa should adopt the four-tiered risk classification system for medical devices recommended by the Global Harmonization Task Force (GHTF), under which Class A represents the lowest risk and Class D represents the highest, according to draft comments provided to IMDRM by the South African Medical Device Industry Association (SAMED). Includes the full text of Draft South African Device Regulations.

Manufacturers of joint replacement implants supplied in Australia should be able to make the switch from Class IIb (medium-high risk) to Class III (high risk) in two years, the Therapeutic Goods Administration (TGA) says.

A unique device identification (UDI) system would be phased in over a period of years based on products in the premarket risk class, according to final guidance issued by the Global Harmonization Task Force (GHTF) Ad Hoc Working Group (AHWG).

Health Canada is developing an 18-month pilot program that will use foreign regulatory reviews in the evaluation of medical device, drug and biological premarket submissions.

Entities importing radiation-emitting devices into the U.S. — including U.S. agents for foreign devicemakers and domestic importers, as well as devicemakers themselves — can smooth those products’ arrival by using Affirmation of Compliance (AofC) codes detailed in a Sept. 6 U.S. Food and Drug Administration (FDA) letter.

The U.S. moved closer into line with international patent law with President Barack Obama’s Sept. 16 signing into law of patent overhaul legislation that implements a first-to-file standard in the U.S. for patent approval.

Manufacturers distributing internationally could find themselves confused by a draft U.S. Food and Drug Administration (FDA) guidance’s stipulation that reprocessing instructions list legally marketed cleaning devices, accessories and agents, Johnson & Johnson (J&J) says.

Regulatory appraisals of clinical performance data related to in vitro diagnostic (IVD) medical devices should give careful consideration to whether investigators published multiple reports on the same group of patients, in order to avoid over-weighting the evidence, a draft Global Harmonization Task Force guidance states.