Category Archives: Regulatory

EU Parliament Votes to Enact MDR and IVDR

In early April the EU Parliament voted to enact the Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulations (IVDR). The regulations are due to be published in the Official Journal of the European Union in May 2017. Following publication, there will be a three year transition period for the MDR and a five […]

FDA Releases 71 Device Product Codes Exempt from All Premarket Notification Requirements

On April 13, 2017, as part of the US FDA’s continued efforts to comply with the 21st Century Cures Act of 2016, the Agency published a list of 71 low-risk Class I medical device product codes that are exempt from all premarket notification requirements (i.e. 510(k) clearance). While the list includes product codes for ophthalmic and […]

FDA Publishes List of Over 1,000 Devices Exempted from Premarket Notification Requirements

On March 14, 2017 the US FDA published a notice in the Federal Register (FR Doc Number 217-04938) indicating that the Agency has identified a list of Class II devices that, when finalized, will be exempted from premarket notification requirements (i.e. 510(k)).   The list encompasses 1,003 class II devices, many of which were previously identified […]

US and EU Reach Agreement on Pharmaceutical Inspections

On March 2, 2017 the US FDA and the European Medicines Agency announced that the Agencies had completed an exchange of letters amending the 1998 US-EU Mutual Recognition Agreement.   The exchange of letters is the culmination of nearly three years of work between the two Agencies that began in May 2014 with the initiation of […]

China FDA Launches New Guidelines

Since returning from the country’s New Year Celebration in early February, the China FDA (CFDA) has released a minimum of six new technical review guidelines.  These new guidelines include:  Device:  Bone Filling Materials Class III, Release Date:  February 10, 2017 This technical review guideline addresses bone filling materials (i.e. silicone/calcium phosphorous) are utilized to repair […]

FDA Updates Comment Period for new GLP Regulations

On October 31, 2016 the US FDA published a notification in the Federal Register (81 FR 75351) extending the comment period for the Agency’s proposal to amend the good laboratory practice (GLP) regulations for nonclinical studies. This extension was due to requests from interested parties asking that the original 90-day comment period be extended by […]