medical device regulations and approval

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FDAMAPMaking Regulations Easy….CUSTOMIZED TRAINING

FOR MEDICAL DEVICE APPROVAL

www.FDAMap.comEmail: Info@FDAMap.com

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: info@FDAMap.com | 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:

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