Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

New FDA Informed Consent Rules Set for March 2012 Implementation

New informed consent requirements for some medical device clinical trials in the US will go into effect March 7, 2012.

The rules will require some clinical trial sponsors and investigators to include statements in their Informed Consent documents that clinical trial data will be entered into a database available via the website www.clinicaltrials.gov. Applicable clinical trials falling under the scope of the new rule include controlled intervention studies of device subject to FDA regulation, studies involving devices manufactured in the US, or studies conducted under Investigational Device Exemptions (IDE).

The onus is on sponsors and investigators to determine whether their clinical trials must comply with the new rules. Applicable clinical trials initiated on or after March 7, 2012 must comply with these requirements.

According to 21 CFR 50.25(c), Informed Consent documents for clinical trials falling under the new rule must include the following statement verbatim:

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Medical device clinical trials specifically excluded from the new Informed Consent rules include small feasibility trials as well as trials for prototype devices with primary measures of feasibility.

Markets: USATags: clinical trial, FDA, informed consent, medical device

Author: Stewart EisenhartDate: February 11, 2012

China Allows Clinical Trial Waivers for Some Class II Medical Devices

Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.

China’s State Food and Drug Administration (SFDA) has waived local clinical trial requirements for 21 types of Class II medical devices equivalent to products currently on the Chinese market.

To qualify for the waiver, applicants must provide SFDA authorities with “comparative illustrations” of how their devices are equivalent to devices already approved in China. Evidence of equivalence should include data about a device’s functionality, manufacturing materials and composition, and technical performance indicators. Information regarding a device’s sterilization methods, expected uses and household uses should also be included.

The types of devices eligible for the waiver include:

Surgical Instruments	Orthopedic Surgical Instruments	Injection and Puncture Instruments
General Examination Instruments	Electrical Medical Devices	Optical and Endoscopic Devices
Ultrasonic Devices	Traditional Chinese Medical Devices	X-ray Parts and Equipment
Clinical Lab Testing Equipment	Cardiopulmonary Bypass and Circulation Equipment	ER and operational equipment
Stomatology Equipment	Ward Room Equipment	Cold Therapy and Low Temperature Storage Equipment
Stomatology Materials	Medical Health Dressing	Polymer Materials