CFDA New Clinical Data Requirements for Foreign medical devices

CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows: Foreign clinical trials must […]

FDA New Guidance on De Novo Classification Process

On October 30, 2017 FDA published a new guidance that describes the process for the submission and review of a De Novo classification request for novel devices, that are automatically classified as Class III devices because they don’t have predicates. And allowing them to be down classified to Class I or Class II devices. A […]

2018 FDA Small-Business Medical Device User Fees

The US FDA has published new guidance explaining how companies should apply to qualify for small-business medical device user fees instead of much higher standard fees. Generally, companies must have no more than $100 million in sales to qualify for the FDA’s small business user fee program. The guidance includes separate requirements for US-based and […]

FDA Publishes a New List of Class II 510(K) Exempted Devices

[vc_row][vc_column width=”1/2″][vc_column_text] FDA Publishes a New List of Class II 510(K) Exempted Devices On July 11, 2017, the US Food and Drug Administration (FDA) has finalized the list of 1,003 types of class II 510(K) exempted medical devices. According to the agency these devices do not present risks that require premarket notification review to provide […]

FDA NEWS: Priority Review for Generic on the Way

On June 19, 2017, the US Food and Drug Administration (FDA) released the draft guidance on the priority review of the applications for generics entitled” ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” The Pre-Submission Facility Correspondence (PFC) process has been identified by the FDA as part of the performance goals and program enhancements for […]

Nanomaterial Submissions on the Rise

Based on recent FDA analysis, the number of submissions of drugs with nanomaterials has risen considerably over the last two decades. Of these, 65% are investigational new drugs, 17% are new drug applications and 18% are abbreviated new drug applications, with the largest class of products being liposomal formulations intended for cancer treatments. This analysis […]

Chinese Regulators May be Abolishing Medical Device Testing Fees

In late March, the Chinese Ministry of Finance announced that it will abolish several government fees, including medical device testing fees associated with CFDA registration. The new policy went into effect April 1, 2017. So far, only the CFDA’s Shanghai testing center has officially implemented this change, the other testing laboratories in Beijing and Zhejiang […]

CFDA Proposes Draft Lowering Barriers for Foreign Drug Manufacturers

In March 2017, the China Food and Drug Administration (CFDA) has released draft rules allowing Multinational Companies to include Chinese patients in the earliest possible stages of drug multi-regional clinical trials (MRCTs). These policies are meant to significantly reduce foreign drug registration timelines. The changes affect the following areas: 1) For imported chemical drugs and […]

Do We Really Need Regulatory Intelligence?

Regulatory intelligence (RI) has emerged as an essential tool for regulatory professionals, but do we really need it? The simple answer is, yes. Using RI will help you to become an effective regulatory professional by helping you to develop the most effective regulatory strategies, while at the same time helping to avoid costly and time-consuming […]

News-03/30/2017

Industry Wants FDA to Hit the Brakes on Quality Metrics Program The US Food and Drug Administration’s (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow. FDA Unveils Regulatory Science Progress Report The report, covering fiscal years 2015 and 2016, notes significant US Food and Drug […]