DOCSLIB.ORG

487 Part 878—General and Plastic Surgery Devices

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
487 Part 878—General and Plastic Surgery Devices Food and Drug Administration, HHS Pt. 878 generated using electrostatic spark dis- 878.3925 Plastic surgery kit and accessories. charge (spark gap), electromagneti- cally repelled membranes, or piezo- Subpart E—Surgical Devices electric crystal arrays, and focused 878.4010 Tissue adhesive. onto the stone with either a specially 878.4011 Tissue adhesive with adjunct wound designed reflector, dish, or acoustic closure device for topical approximation lens. The shock waves are created of skin. under water within the shock wave 878.4014 Nonresorbable gauze/sponge for ex- generator, and are transferred to the ternal use. 878.4015 Wound dressing with poly (diallyl patient’s body using an appropriate dimethyl ammonium chloride) acoustic interface. After the stone has (pDADMAC) additive. been fragmented by the focused shock 878.4018 Hydrophilic wound dressing. waves, the fragments pass out of the 878.4020 Occlusive wound dressing. body with the patient’s urine. 878.4022 Hydrogel wound dressing and burn (b) Classification. Class II (special dressing. controls) (FDA guidance document: 878.4025 Silicone sheeting. ‘‘Guidance for the Content of Pre- 878.4040 Surgical apparel. 878.4100 Organ bag. market Notifications (510(k)’s) for 878.4160 Surgical camera and accessories. Extracorporeal Shock Wave 878.4200 Introduction/drainage catheter and Lithotripters Indicated for the Frag- accessories. mentation of Kidney and Ureteral 878.4300 Implantable clip. Calculi.’’) 878.4320 Removable skin clip. 878.4340 Contact cooling system for aes- [65 FR 48612, Aug. 9, 2000] thetic use. 878.4350 Cryosurgical unit and accessories. PART 878—GENERAL AND PLASTIC 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alo- SURGERY DEVICES pecia. 878.4370 Surgical drape and drape acces- Subpart A—General Provisions sories. 878.4371 Irrigating wound retractor device. Sec. 878.4380 Drape adhesive. 878.1 Scope. 878.4400 Electrosurgical cutting and coagu- 878.3 Effective dates of requirement for pre- lation device and accessories. market approval. 878.4410 Low energy ultrasound wound 878.9 Limitations of exemptions from sec- cleaner. tion 510(k) of the Federal Food, Drug, 878.4420 Electrosurgical device for over-the- and Cosmetic Act (the act). counter aesthetic use. 878.4440 Eye pad. Subpart B—Diagnostic Devices 878.4450 Nonabsorbable gauze for internal 878.1800 Speculum and accessories. use. 878.4452 Nonabsorbable expandable hemo- Subpart C [Reserved] static sponge for temporary internal use. 878.4454 Non-absorbable, hemostatic gauze Subpart D—Prosthetic Devices for temporary internal use. 878.4460 Non-powdered surgeon’s glove. 878.3250 External facial fracture fixation ap- 878.4470 Surgeon’s gloving cream. pliance. 878.4490 Absorbable hemostatic agent and 878.3300 Surgical mesh. dressing. 878.3500 Polytetrafluoroethylene with car- 878.4493 Absorbable poly(glycolide/l-lactide) bon fibers composite implant material. surgical suture. 878.3530 Silicone inflatable breast pros- 878.4494 Absorbable poly(hydroxybutyrate) thesis. surgical suture produced by recombinant 878.3540 Silicone gel-filled breast prosthesis. DNA technology. 878.3550 Chin prosthesis. 878.4495 Stainless steel suture. 878.3590 Ear prosthesis. 878.4520 Polytetrafluoroethylene injectable. 878.3610 Esophageal prosthesis. 878.4580 Surgical lamp. 878.3680 Nose prosthesis. 878.4590 Focused ultrasound stimulator sys- 878.3720 Tracheal prosthesls. tem for aesthetic use. 878.3750 External prosthesis adhesive. 878.4630 Ultraviolet lamp for dermatologic 878.3800 External aesthetic restoration pros- disorders. thesis. 878.4635 Sunlamp products and ultraviolet 878.3900 Inflatable extremity splint. lamps intended for use in sunlamp prod- 878.3910 Noninflatable extremity splint. ucts. 487 VerDate Sep<11>2014 17:11 May 16, 2018 Jkt 244077 PO 00000 Frm 00497 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31 kpayne on DSK54DXVN1OFR with $$_JOB § 878.1 21 CFR Ch. I (4–1–18 Edition) 878.4660 Skin marker. SOURCE: 53 FR 23872, June 24, 1988, unless 878.4670 Internal tissue marker. otherwise noted. 878.4680 Nonpowered, single patient, port- EDITORIAL NOTE: Nomenclature changes to able suction apparatus. part 878 appear at 73 FR 35341, June 23, 2008. 878.4683 Non-Powered suction apparatus de- vice intended for negative pressure wound therapy. Subpart A—General Provisions 878.4685 Extracorporeal shock wave device for treatment of chronic wounds. § 878.1 Scope. 878.4700 Surgical microscope and acces- (a) This part sets forth the classifica- sories. tion of general and plastic surgery de- 878.4730 Surgical skin degreaser or adhesive vices intended for human use that are tape solvent. in commercial distribution. 878.4750 Implantable staple. (b) The identification of a device in a 878.4755 Absorbable lung biopsy plug. 878.4760 Removable skin staple. regulation in this part is not a precise 878.4780 Powered suction pump. description of every device that is, or 878.4790 Powered surgical instrument for will be, subject to the regulation. A improvement in the appearance of manufacturer who submits a pre- cellulite. market notification submission for a 878.4800 Manual surgical instrument for device under part 807 cannot show general use. merely that the device is accurately 878.4810 Laser surgical instrument for use in described by the section title and iden- general and plastic surgery and in der- tification provision of a regulation in matology. this part, but shall state why the de- 878.4815 Magnetic surgical instrument sys- vice is substantially equivalent to tem. 878.4820 Surgical instrument motors and ac- other devices, as required by § 807.87 of cessories/attachments. this chapter. 878.4830 Absorbable surgical gut suture. (c) To avoid duplicative listings, a 878.4840 Absorbable polydioxanone surgical general and plastic surgery device that suture. has two or more types of uses (e.g., 878.4930 Suture retention device. used both as a diagnostic device and as 878.4950 Manual operating table and acces- a therapeutic device) is listed in one sories and manual operating chair and subpart only. accessories. (d) References in this part to regu- 878.4960 Operating tables and accessories latory sections of the Code of Federal and operating chairs and accessories. Regulations are to chapter I of title 21 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture. unless otherwise noted. 878.5010 Nonabsorbable polypropylene sur- (e) Guidance documents referenced in gical suture. this part are available on the Internet 878.5020 Nonabsorbable polyamide surgical at http://www.fda.gov/MedicalDevices/ suture. DeviceRegulationandGuidance/ 878.5030 Natural nonabsorbable silk surgical GuidanceDocuments/default.htm.. suture. 878.5035 Nonabsorbable expanded polytetra- [53 FR 23872, June 24, 1988, as amended at 67 fluoroethylene surgical suture. FR 77676, Dec. 19, 2002; 78 FR 18233, Mar. 26, 878.5040 Suction lipoplasty system. 2013] 878.5050 Surgical smoke precipitator. § 878.3 Effective dates of requirement Subpart F—Therapeutic Devices for premarket approval. A device included in this part that is 878.5070 Air-handling apparatus for a sur- classified into class III (premarket ap- gical operating room. proval) shall not be commercially dis- 878.5350 Needle-type epilator. 878.5360 Tweezer-type epilator. tributed after the date shown in the 878.5400 Low level laser system for aesthetic regulation classifying the device unless use the manufacturer has an approval 878.5650 Topical oxygen chamber for ex- under section 515 of the act (unless an tremities. exemption has been granted under sec- 878.5900 Nonpneumatic tourniquet. tion 520(g)(2) of the act). An approval 878.5910 Pneumatic tourniquet. under section 515 of the act consists of AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, FDA’s issuance of an order approving 360j, 360l, 371. an application for premarket approval 488 VerDate Sep<11>2014 17:11 May 16, 2018 Jkt 244077 PO 00000 Frm 00498 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31 kpayne on DSK54DXVN1OFR with $$_JOB Food and Drug Administration, HHS § 878.9 (PMA) for the device or declaring com- (c) A device identified in a regulation pleted a product development protocol in this part that is classified into class (PDP) for the device. III and that is subject to the transi- (a) Before FDA requires that a device tional provisions of section 520(l) of the commercially distributed before the act is automatically classified by stat- enactment date of the amendments, or ute into class III and must have an ap- a device that has been found substan- proval under section 515 of the act be- tially equivalent to such a device, has fore being commercially distributed. an approval under section 515 of the Accordingly, the regulation for such a act, FDA must promulgate a regula- class III transitional device states that tion under section 515(b) of the act re- as of the enactment date of the amend- quiring such approval, except as pro- ments, May 28, 1976, the device must vided in paragraphs (b) and (c) of this have an approval under section 515 of section. Such a regulation under sec- the act before commercial distribution. tion 515(b) of the act shall not be effec- tive during the grace period ending on § 878.9 Limitations of exemptions from the 90th day after its promulgation or section 510(k) of the Federal Food, on the last day of the 30th full calendar Drug, and Cosmetic Act (the act). month after the regulation that classi- The exemption from the requirement fies the device into class III is effec- of premarket notification (section tive,
Load more

Recommended publications
  • Review of Plastic Surgery Biomaterials and Current Progress in Their 3D Manufacturing Technology
    materials Review Review of Plastic Surgery Biomaterials and Current Progress in Their 3D Manufacturing Technology 1,2, 3, 4 5 5 4 Wei Peng y, Zhiyu Peng y , Pei Tang , Huan Sun , Haoyuan Lei , Zhengyong Li , Didi Hui 6 , Colin Du 6, Changchun Zhou 5 and Yongwei Wang 1,2,* 1 Department of Palliative Care, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu 610041, China; [email protected] 2 Occupational Health Emergency Key Laboratory of West China Fourth Hospital, Sichuan University, Chengdu 610041, China 3 Department of Thoracic Surgery, West China School of Medicine, West China Hospital, Sichuan University, Chengdu 610041, China; [email protected] 4 Department of Burn and Plastic Surgery, West China School of Medicine, West China Hospital, Sichuan University, Chengdu 610041, China; [email protected] (P.T.); [email protected] (Z.L.) 5 National Engineering Research Center for Biomaterials, Sichuan University, Chengdu 610064, China; [email protected] (H.S.); [email protected] (H.L.); [email protected] (C.Z.) 6 Innovatus Oral Cosmetic & Surgical Institute, Norman, OK 73069, USA; [email protected] (D.H.); [email protected] (C.D.) * Correspondence: [email protected] These authors contributed equally to this paper. y Received: 18 August 2020; Accepted: 14 September 2020; Published: 16 September 2020 Abstract: Plastic surgery is a broad field, including maxillofacial surgery, skin flaps and grafts, liposuction and body contouring, breast surgery, and facial cosmetic procedures. Due to the requirements of plastic surgery for the biological safety of materials, biomaterials are widely used because of its superior biocompatibility and biodegradability.
    [Show full text]
  • Complementing Surgical with Biomedical and Engineering Methods to Evolve Lip and Nose Reconstruction
    Complementing surgical with biomedical and engineering methods to evolve lip and nose reconstruction Inauguraldissertation zur Erlangung der Würde eines Doktors der Philosophie vorgelegt der Medizinischen Fakultät der Universität Basel von Andreas Albert Müller aus Basel (Basel-Stadt), Oftringen (Aargau), Schweiz Basel, 2013 Genehmigt von der Medizinischen Fakultät auf Antrag von Prof. Dr. Dr. Dr.h.c. Hans-Florian Zeilhofer (Fakultätsverantwortlicher und Korreferent) Prof. Dr. Ivan Martin (Dissertationsleiter) Prof. em. Dr. Dr. Dieter Schumann (externer Experte) Basel, den 16. September 2013 Prof. Dr. Christoph Beglinger Dekan der Medizinischen Fakultät Contents Abstract ...................................................................................................................................... 1 1. Introduction ........................................................................................................................... 3 Shape reconstruction of central facial defects ...................................................................... 3 Current standards of microsurgical tissue transfer to the face ............................................. 4 Introducing the functional vascular anatomy to cleft lip surgery .......................................... 4 Combined cleft lip and palate repair to reduce the burden of care ...................................... 5 Umbilical cord stem cells to heal inborn bone defects .......................................................... 5 2. First study: Missing facial parts computed
    [Show full text]
  • Regulations Governing the Classification of Medical Devices (Draft)
    Regulations Governing the Classification of Medical Devices (Draft) Article 1 These Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical Devices Act (hereinafter “this Act”). Article 2 Medical devices are classified into the following categories according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty: 1. Clinical chemistry and clinical toxicology devices 2. Hematology and pathology devices 3. Immunology and microbiology devices 4. Anesthesiology devices 5. Cardiovascular devices 6. Dental devices 7. Ear, nose, and throat devices 8. Gastroenterology and urology devices 9. General and plastic surgery devices 10. General hospital and personal use devices 11. Neurological devices 12. Obstetrical and gynecological devices 13. Ophthalmic devices 14. Orthopedic devices 15. Physical medicine devices 16. Radiology devices Article 3 Medical devices are classified into the following classes according to their risk level: 1. Class I: Low risk 2. Class II: Medium risk 3. Class III: High risk 1 Article 4 Product items of the medical device classification are specified in the Annex. In addition to rules stated in the Annex, medical devices whose function, intended use, or working principle are special may have their classification determined according to the following rules: 1. If two or more categories, classes, or product items are applicable to the same medical device, the highest class of risk level is assigned. 2. The accessory to a medical device, intended specifically by the manufacturer for use with a particular medical device, is classified the same as the particular medical device, unless otherwise specified in the Annex. 3.
    [Show full text]
  • Synergistic Collaboration 30TH ANNUAL EDUCATIONAL CONFERENCE Fort Worth, Texas, USA
    ABSTRACTS International Anaplastology Association Synergistic Collaboration 30TH ANNUAL EDUCATIONAL CONFERENCE Fort Worth, Texas, USA International Anaplastology Association | 1 WELCOME Welcome Dear Colleagues As President of the International Anaplastology Association, I am pleased to welcome you to the 30th Annual Educational Conference that will take place in Fort Worth, Texas. The theme chosen by our Conference Planning Committee for this year will be Synergistic Collaboration, which translates the importance of collaboration among professionals from all areas of expertise involved in the rehabilitation of our patients with a common goal to improve their “Quality of Life”. Many congratulations to my dear friend and Conference Chair Suzanne Verma for her wonderful and endless dedication to organize such a fantastic CONTENTS scientific program. President‘s Welcome 02 Program Chair Welcome 03 To our keynote speakers, invited speakers and colleagues, please accept my warmest regards and be very welcome to this years “IAA Family Reunion”. Conference Sponsors 04 It has been an honor and privilege to serve as President of the IAA this year. At A Glance Schedule 06 Pre-Conference Program 10 I want to thank for the tremendous support from the IAA Board of Directors and our Executive Director Rachel Brooke, who dedicated their time and Conference Day 1 16 expertise to the development of this Conference. Conference Day 2 33 This meeting will be a great opportunity not only to expand our knowledge by Post-Conference Program 48 exchanging our experiences with the most renowned and talented speakers, Poster Presentations 52 some already known by you and some new ones. Notes 54 Our “Anaplastology Family “ is with arms wide open to receive new members and attendants from various specialties involved in the rehabilitation of people suffering from facial and somato disfigurement.
    [Show full text]
  • Classification, History, and Future Prospects of Maxillofacial Prosthesis
    Hindawi International Journal of Dentistry Volume 2019, Article ID 8657619, 7 pages https://doi.org/10.1155/2019/8657619 Review Article Classification, History, and Future Prospects of Maxillofacial Prosthesis Fernanda Pereira de Caxias,1 Daniela Micheline dos Santos,1,2 Lisiane Cristina Bannwart,1 Clovis Lamartine de Moraes Melo Neto,1 and Marcelo Coelho Goiato 1,2 1Department of Dental Materials and Prosthodontics, São Paulo State University (UNESP), School of Dentistry, Araçatuba, São Paulo, Brazil 2Center for Oral Oncology, UNESP, Araçatuba, São Paulo, Brazil Correspondence should be addressed to Marcelo Coelho Goiato; [email protected] Received 12 March 2019; Revised 5 June 2019; Accepted 4 July 2019; Published 18 July 2019 Academic Editor: Carlos A. Munoz-Viveros Copyright © 2019 Fernanda Pereira de Caxias et al. -is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. -is review presents a classification system for maxillofacial prostheses, while explaining its types. It also aims to describe their origin and development, currently available materials, and techniques, predicts the future requirements, and subsequently discusses its avenues for improvement as a restorative modality. A literature search of the PubMed/Medline database was performed. Articles that discussed the history, types, materials, fabrication techniques, clinical implications, and future ex- pectations related to maxillofacial prostheses and reconstruction were included. Fifty-nine articles were included in this review. Maxillofacial prostheses were classified as restorative or complementary with subclassifications based on the prostheses finality. -e origin of maxillofacial prostheses is unclear; however, fabrication techniques and materials have undergone several changes throughout history.
    [Show full text]
  • Augmenting Realm of 3D Printing in Restorative Dentistry and Endodontics: a Review Nikita Arun Kamat1,*, Saritha Vallabhaneni2, Prahlad Saraf2, Sandhya Khasnis2
    Review Article International Journal of Dental Materials 2020; 2(1) ISSN:2582-2209 Augmenting realm of 3D printing in restorative dentistry and endodontics: a review Nikita Arun Kamat1,*, Saritha Vallabhaneni2, Prahlad Saraf2, Sandhya Khasnis2 1Postgraduate Student, Department of Conservative Dentistry & Endodontics, PMNM Dental College, Bagalkot, Karnataka, India . 2Professor, Department of Conservative Dentistry & Endodontics, PMNM Dental College, Bagalkot, Karnataka, India . INFORMATIO N ABSTRACT The 3D printing is entrenching itself as an advancing forefront in the field of Article History dentistry. The 3D printing technology mostly works on the concept of additive manufacturing, which has its advantages over in contrast to the subtractive Received 2nd February 2020 manufacturing process. Advancement of this technology has improved diag- nostic accuracy, easy treatment delivery and reduced chair side time allowing Received revised the dentist to provide treatment effectively and with high precision. Education- 6th March 2020 al programs which utilise 3D printed models stimulate better training of dental skills in students and trainees. Thus, 3D printing enables to provide a holistic th Accepted 6 March 2020 approach to ameliorate the health and wellbeing of patients. This review arti- cle provides an overview of different methods of 3D Printing and its applica- Available online tions focusing on Restorative dentistry and Endodontics. 9th March 2020 KEYWORDS 1. Introduction Digitalization through 3D printing is a remarkable advancement in the field of 3D printing dentistry which allows precision in treating patients. It is as an emerging tech- nology with its wide variety of applications in the dental field. In the present CAD-CAM Era, this technology ensures quality and quantity in dental care, making it a Fused deposition modelling preferred modality of treatment [1].
    [Show full text]
  • 523 Part 878—General and Plastic Surgery Devices
    Food and Drug Administration, HHS Pt. 878 table. Prior to treatment, the urinary 878.3800 External aesthetic restoration pros- stone is targeted using either an inte- thesis. gral or stand-alone localization/imag- 878.3900 Inflatable extremity splint. ing system. Shock waves are typically 878.3910 Noninflatable extremity splint. 878.3925 Plastic surgery kit and accessories. generated using electrostatic spark dis- charge (spark gap), electromagneti- Subpart E—Surgical Devices cally repelled membranes, or piezo- electric crystal arrays, and focused 878.4010 Tissue adhesive. onto the stone with either a specially 878.4011 Tissue adhesive with adjunct wound designed reflector, dish, or acoustic closure device for topical approximation of skin. lens. The shock waves are created 878.4014 Nonresorbable gauze/sponge for ex- under water within the shock wave ternal use. generator, and are transferred to the 878.4015 Wound dressing with poly (diallyl patient’s body using an appropriate dimethyl ammonium chloride) acoustic interface. After the stone has (pDADMAC) additive. been fragmented by the focused shock 878.4018 Hydrophilic wound dressing. waves, the fragments pass out of the 878.4020 Occlusive wound dressing. body with the patient’s urine. 878.4022 Hydrogel wound dressing and burn dressing. (b) Classification. Class II (special 878.4025 Silicone sheeting. controls) (FDA guidance document: 878.4040 Surgical apparel. ‘‘Guidance for the Content of Pre- 878.4100 Organ bag. market Notifications (510(k)’s) for 878.4160 Surgical camera and accessories. Extracorporeal Shock Wave 878.4165 Wound autofluorescence imaging Lithotripters Indicated for the Frag- device. mentation of Kidney and Ureteral 878.4200 Introduction/drainage catheter and Calculi.’’) accessories.
    [Show full text]
  • No.DCG (I/Misc./2017 (68) Central Drugs Standard Control
    No.DCG (I/Misc./2017 (68) Central Drugs Standard Control Organisation Directorate General of Health Services Office of Drugs Controller General India FDA Bhawan, Kotla Road, New Delhi Dated: 29th June, 2017. Notice The Drugs & Cosmetics Act, 1940 is an Act to regulate import, manufacture, distribution and sale of drugs and cosmetics. It extends to the whole of India. Further, the Drugs & Cosmetics Rules, 1945 have been put in place which are updated from time to time for uniform implementation of the statutory requirements. The devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Govt. by notification in official Gazette, after consultation with the Board, fall under the definition of drug. The list of devices notified so far are appended below: S.NO. NAME OF THE DEVICE 1. Disposable Hypodermic Syringes 2. Disposable Hypodermic Needles 3. Disposable Perfusion Sets 4. In vitro Diagnostic Devices for HIV, HbsAg and HCV 5. Cardiac Stents 6. Drug Eluting Stents 7. Catheters 8. Intra Ocular Lenses 9. I.V. Cannulae 10. Bone Cements 11. Heart Valves 12. Scalp Vein Set 13. Orthopedic Implants 14. Internal Prosthetic Replacements 15. Ablation Device The Medical Devices Rules, 2017* have been notified and would come into force with effect from 1stday of January, 2018. Criteriafor Classification of medical Page 1 of 1 Annexure DRAFT LIST OF MEDICAL DEVICES AND IN VITRO DIAGNOSTICS ALONG WITH THEIR RISK CLASS A - LIST OF MEDICAL DEVICES ALONG WITH THEIR RISK CLASS S.N.
    [Show full text]
  • 392 Part 878—General and Plastic Surgery
    § 876.5990 21 CFR Ch. I (4–1–08 Edition) sterile infant gavage set, gastro- ‘‘Guidance for the Content of Pre- intestinal string and tubes to locate in- market Notifications (510(k)’s) for ternal bleeding, double lumen tube for Extracorporeal Shock Wave intestinal decompression or intubation, Lithotripters Indicated for the Frag- feeding tube, gastroenterostomy tube, mentation of Kidney and Ureteral Levine tube, nasogastric tube, single Calculi.’’) lumen tube with mercury weight bal- loon for intestinal intubation or de- [65 FR 48612, Aug. 9, 2000] compression, and gastro-urological ir- rigation tray (for gastrological use). PART 878—GENERAL AND PLASTIC (b) Classification. (1) Class II (special SURGERY DEVICES controls). The barium enema retention catheter and tip with or without a bag Subpart A—General Provisions that is a gastrointestinal tube and ac- Sec. cessory is exempt from the premarket 878.1 Scope. notification procedures in subpart E of 878.3 Effective dates of requirement for pre- this part subject to the limitations in market approval. § 876.9. 878.9 Limitations of exemptions from sec- (2) Class I (general controls) for the tion 510(k) of the Federal Food, Drug, dissolvable nasogastric feed tube guide and Cosmetic Act (the act). for the nasogastric tube. The class I de- vice is exempt from the premarket no- Subpart B—Diagnostic Devices tification procedures in subpart E of 878.1800 Speculum and accessories. part 807 of this chapter subject to § 876.9. Subpart C [Reserved] [49 FR 573, Jan. 5, 1984, as amended at 65 FR Subpart D—Prosthetic Devices 2317, Jan. 14, 2000; 65 FR 76932, Dec.
    [Show full text]
  • Characterisation of Implant Supported Soft Tissue Prostheses Produced with 3D Colour Printing Technology
    Characterisation of Implant Supported Soft Tissue Prostheses Produced with 3D Colour Printing Technology School of Clinical Dentistry The University of Sheffield A PhD thesis submitted by Faraedon M. M. Zardawi November 2012 i Dedication I lovingly dedicate this thesis to my wife Wasnaa, who has supported me each step of the way. To my parents, who always stood by me, gone now, but never forgotten. I will miss them always and love them forever. To my lovely daughter Farah, my sons Ahmed and Ali, their wives Marwa and Israa and my sweet grand kids Lavin, Lana and Meran; that is my lovely family. ii Acknowledgments I would like to convey my gratitude to my supervisors, Professor Julian Yates and Professor Richard van Noort for providing me with the inspiration and support during my PhD work. Their kind but rigorous oversight of this project constantly gave me the motivation to perform to my maximum ability. I was very fortunate to have been able to work with them; their detailed and constructive comments were vital to the development of this thesis. I would also like to extend my gratitude to Mr. David Wildgoose for his advice and support I am most grateful to the other members of the project team at Sheffield based Industrial Design Company, Fripp Design and Research: Mrs Sue Roberts, Tom Fripp, Neil Frewer and Steve Roberts for their time and expertise throughout this project. Very special thanks to Neil Frewer for his great help in designing the alignment process and producing the magnet boss designs for the prostheses.
    [Show full text]
  • DCGI Notice 2017-68
    No.DCG (I/Misc./2017 (68) Central Drugs Standard Control Organisation Directorate General of Health Services Office of Drugs Controller General India FDA Bhawan, Kotla Road, New Delhi Dated: 29th June, 2017. Notice The Drugs & Cosmetics Act, 1940 is an Act to regulate import, manufacture, distribution and sale of drugs and cosmetics. It extends to the whole of India. Further, the Drugs & Cosmetics Rules, 1945 have been put in place which are updated from time to time for uniform implementation of the statutory requirements. The devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Govt. by notification in official Gazette, after consultation with the Board, fall under the definition of drug. The list of devices notified so far are appended below: S.NO. NAME OF THE DEVICE 1. Disposable Hypodermic Syringes 2. Disposable Hypodermic Needles 3. Disposable Perfusion Sets 4. In vitro Diagnostic Devices for HIV, HbsAg and HCV 5. Cardiac Stents 6. Drug Eluting Stents 7. Catheters 8. Intra Ocular Lenses 9. I.V. Cannulae 10. Bone Cements 11. Heart Valves 12. Scalp Vein Set 13. Orthopedic Implants 14. Internal Prosthetic Replacements 15. Ablation Device The Medical Devices Rules, 2017* have been notified and would come into force with effect from 1stday of January, 2018. Criteriafor Classification of medical Page 1 of 1 Annexure DRAFT LIST OF MEDICAL DEVICES AND IN VITRO DIAGNOSTICS ALONG WITH THEIR RISK CLASS A - LIST OF MEDICAL DEVICES ALONG WITH THEIR RISK CLASS S.N.
    [Show full text]
  • 392 Part 878—General and Plastic Surgery Devices
    Pt. 878 21 CFR Ch. I (4–1–11 Edition) generated using electrostatic spark dis- 878.3925 Plastic surgery kit and accessories. charge (spark gap), electromagneti- cally repelled membranes, or piezo- Subpart E—Surgical Devices electric crystal arrays, and focused 878.4010 Tissue adhesive. onto the stone with either a specially 878.4011 Tissue adhesive with adjunct wound designed reflector, dish, or acoustic closure device for topical approximation lens. The shock waves are created of skin. under water within the shock wave 878.4014 Nonresorbable gauze/sponge for ex- generator, and are transferred to the ternal use. 878.4015 Wound dressing with poly (diallyl patient’s body using an appropriate dimethyl ammonium chloride) acoustic interface. After the stone has (pDADMAC) additive. been fragmented by the focused shock 878.4018 Hydrophilic wound dressing. waves, the fragments pass out of the 878.4020 Occlusive wound dressing. body with the patient’s urine. 878.4022 Hydrogel wound dressing and burn (b) Classification. Class II (special dressing. controls) (FDA guidance document: 878.4025 Silicone sheeting. ‘‘Guidance for the Content of Pre- 878.4040 Surgical apparel. 878.4100 Organ bag. market Notifications (510(k)’s) for 878.4160 Surgical camera and accessories. Extracorporeal Shock Wave 878.4200 Introduction/drainage catheter and Lithotripters Indicated for the Frag- accessories. mentation of Kidney and Ureteral 878.4300 Implantable clip. Calculi.’’) 878.4320 Removable skin clip. 878.4340 Contact cooling system for aes- [65 FR 48612, Aug. 9, 2000] thetic use. 878.4350 Cryosurgical unit and accessories. PART 878—GENERAL AND PLASTIC 878.4370 Surgical drape and drape acces- sories.
    [Show full text]