MVF Laser Photodynamic Therapy Device: System, Laser, Photodynamic Therap Product Code: MVF Device Class: 3 Recognized Consensus Standards IEC 60825-1 (Second edition – 2007) Safety of laser products – Part 1: Equipment classification and requirements CORRIGENDUM 1 IEC 60825-1 (Second edition – 2007) I-SH 01 SAFETY OF LASER PRODUCTS – Part 1: Equipment classification and requirements, INTERPRETATION SHEET 1 IEC
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
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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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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