medical device regulations and approval
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FDAMAPMaking Regulations Easy….CUSTOMIZED TRAINING
FOR MEDICAL DEVICE APPROVAL
www.FDAMap.comEmail: [email protected]
410-501-577720203 Goshen Rd, Suite 261
Gaithersburg, MD 20879
FDA'S CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) REGULATES MEDICAL DEVICES SOLD IN THE U.S.
What types of firms are regulated by CDRH…
• The firms which repackage, manufacture, import, or relabel medical devices sold in the U.S. Therefore, the knowledge of FDA medical device regulations is a must for the staffers of such types of firms.
THERE ARE THREE TYPES OF MEDICAL DEVICES…
Class I Class II Class III
Examination gloves Bone fixation screw Dental lasers
Elastic bandages Infusion Pumps Heart valves
Mechanical wheelchair
Blood pressure kit Pacemakers
Most Class I devices are exempt from Premarket Notification 510(k);
Most Class II devices require Premarket Notification 510(k)
Most Class III devices require Premarket Approval
CDRH ALSO REGULATES RADIATION-EMITTING ELECTRONIC PRODUCTS (BOTH NON-MEDICAL AND MEDICAL)
These products include x-ray systems, microwave ovens, lasers, ultrasound equipment, and color televisions.
FOR MORE INFORMATION ON THE BASIC REGULATORY REQUIREMENTS FOR THE DEVICE MANUFACTURERS YOU CAN VISIT:HTTP://1.USA.GOV/1R1KL53
HOW TO KNOW THE CURRENT POSITION OF FDA FOR ANY SPECIFIC TOPIC?
To know the current position of FDA on any topic, refer to FDA Guidance Documents.
For further information, you can attend FDAMap workshops and FDAMap
seminars meant for training and guidance.
DO YOU NEED CUSTOMIZED TRAINING AND CONSULTATIONS??
FDAMap offers customized training for issues related to US FDA Compliance, Pharmacovigilance, Recruitment for Clinical Trials, Quality Assurance and Quality Control, product development strategy and European Medicines Agency (EMA) Compliance.
Our consultants and trainers have many years of experience in handling complexities of drug and device development, clinical trials, FDA regulatory procedures and compliance, and post approval manufacturing and marketing.
FDAMAP WILL TRAIN YOU ON HOW TO PREPARE FOR MEETINGS
WITH THE FDA, THE BEST PRACTICES AND DO’S AND
DON’TS, ETC.
AT FDAMAP YOU GET THE BEST MEDICAL DEVICE CONSULTANTS, WHO ARE WELL VERSED WITH REGULATORY AFFAIRS AND HAVE PROVEN EXPERIENCE IN DEALING WITH FDA AND GETTING FDA MEDICAL DEVICE APPROVAL.
FDAMap has expert trainers and speakers working for it. These are highly experienced individuals, who are already well-known in the pharma industry and have years of international experience in providing regulatory consulting services and FDA medical device training.
www.fdamap.com | 20203 Goshen Rd, Suite 261, Gaithersburg, MD 20879
Email: [email protected] | Phone: 410-501-5777 | (C) Copyright (2015) All Rights Reserved
For more information about our customized workshops and
conferences on FDA medical device guidance and approvals,
please contact us at:
