FDA Regulatory Consulting and Training Services

16
Feb

January 2013 510k Representative Examples of 510ks

January 2013 510k Clearances Representative Examples of 510(k)s Total 510(k)s:                                     224 Total With Summaries:                    210 Total With Statements:                     14 Traditional 510(k)s (Representative) Device: Colladental Barrier: 510(K) No: K100695 (Traditional) | SE Decision Made: 03-Jan-13 Device: Conventus Orthopaedics Fracture Fixation System | 510(K) No: K102689 (Traditional) | SE Decision Made: 17-Jan-13 Device: Therasom-Cast | 510(K) No: K113516 (Traditional) | SE Decision

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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

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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

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25
Jan

Product Code | LZS | Ophthalmic | Excimer Laser System | Device Problems | PMA

By Regulatory Doctor; LinkedIn; Google Plus; Twitter; Facebook Product Code | LZS | Ophthalmic | Excimer Laser System | Device Problems PMA Representative List of PMAs in 2013 under Product Code LZS NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM P970053 S011 09/30/2013 ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYST P020050 S012 09/27/2013 WAVESCAN WAVEFRONT SYSTEM P930016 S038 06/27/2013 TECHNOLAS PERFECT VISION 217Z ZYOPTIX SY P990027

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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

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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

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17
Jan

GCP for Medical Devices

Good Clinical Practice for Medical Devices FDA | GCP | Medical Devices | ASRs | LDTs | IDEs | HDE | Sponsors | IRBs | CIs | Informed Consent | 21 CFR Part 11 | HIPPA | DMC | ICH General 21 CFR 50.54, Process for Handling Referrals to FDA under, Guidance for Clinical Investigators, Institutional Review Boards and Sponsors

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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.