FDA Regulatory Doctor

20
Feb

FDA Approves New Silicone Gel-Filled Breast Implant | Regulatory Doctor

FDA approves new silicone gel-filled breast implant Agency requires post-approval safety studies to assess rare events The U.S. Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.  Natrelle 410

Read more

19
Feb

510k Consulting for Medical Devices and IVDs

510(k) Consulting Services Medical Devices and IVDs Premarket Notification – also called PMN or 510(k) In the United States, each person who wants to market a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA at least 90 days in advance pursuant to section

Read more

8
Feb

DHHS and CMS Have Issued a Proposed Rule to Reform Medicare Regulations

DHHS and CMS Have Issued a Proposed Rule to Reform Medicare Regulations February 7, 2013 This proposed rule would reform Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Access link to the proposal rule at http://www.gpo.gov/fdsys/pkg/FR-2013-02-07/pdf/2013-02421.pdf

7
Feb

Harmonized Standards for CE Marking

Harmonized Standards CE Marking 24 January 2013 New references of harmonised standards for Medical Devices (OJ C22 of 24 January 2013) 2013/C 22/01 Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (1)(Publication of titles and

Read more

26
Jan

Laser Photodynamic Therapy

Laser Photodynamic Therapy Device: Laser Photodynamic Therapy System Product Code: MVF Device Class: 3 Recognized Consensus Standards 12-242 IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use 12-268 IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment

Read more

25
Jan

When a PMA Supplement is Needed | Regulatory Doctor

General Requirements for When a PMA Supplement is Needed  Examples of the types of modifications that require a PMA supplement (21 CFR 814.39(a)), if such changes affect the safety or effectiveness of the device, include, but are not limited to, the following: 1)      new indications for use of the device; 2)      labeling changes; 3)      the use of a different facility

Read more

19
Jan

Management Consulting | Management Consultants | 360 View

Management Consulting | Management Consultants | 360 View We provide management consulting (360 views) to corporate management helping startups, young pharma, and device companies. How we do: We use our confidential and proprietary systematic assessment systems developed over the years.    We consider and use all factors for accurate and precise assessment under the circumstances. We identify root causes. We

Read more

17
Jan

GCP for Medical Devices

Good Clinical Practice (GCP) for Medical Devices 21 CFR 50.54, Process for Handling Referrals to FDA under, Guidance for Clinical Investigators, Institutional Review Boards and Sponsors This guidance is intended to assist clinical investigators, Institutional Review Boards (IRBs), sponsors, and other interested parties in understanding the FDA’s process for handling clinical investigations that include children as subjects and that have

Read more

17
Jan

Supreme Court of Alabama | Brand Drugmakers Can Be Held Liable for Generic-Drug Labeling.

To Download A Copy of the Court Ruling, Please Fill Out the Form Below. Copyright © 2012  Regulatory Doctor.  All Rights Reserved. This web is hosted by Hostgator.