Plamena Entcheva-Dimitrov, PhD, RAC On-line Course. 1
|
|
- Shona Harrison
- 8 years ago
- Views:
Transcription
1 Plamena Entcheva-Dimitrov, PhD, RAC On-line Course 1
2 The Preferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright laws. 2
3 3
4 Federal Agency Part of the Department of Health and Human Services FDA s mission is to protect and promote the public health: noble and honorable job Established in 1938 with an act of Congress under President FD Roosevelt 4
5 Plamena Entcheva-Dimitrov, PhD, RAC 5 5
6 FDA within the Federal Government (* marks major legislations): 1839 Patent Office, Department of State 1849 Chemical Laboratory of the Agricultural Division in the Patent Office, Department of Interior 1862 Chemical Division, Department of Agriculture 1889 Chemical Division, US Department of Agriculture 1890 Division of Chemistry, USDA 1901 Bureau of Chemistry, USDA 1927 Food and Drug Insecticide Administration, USDA 1930 FDA, USDA 1940 FDA, Federal Security Agency 1953 FDA, Department of Health, Education, and Welfare 1979 FDA, Department of Health and Human Services 6
7 Inception of FDA: Per-1906: 1813: the Vaccine Act; first federal law for consumer protection and therapeutic substances All drugs were bought and sold as consumer goods 1848: Drug Importation Act; adulterated quinine in the US Army; lab inspections at ports 1862: Division of Chemistry, FDA s predecessor to inspect food at ports of entry and detention 1902: the Biologics Control Act to license establishments and regulate interstate sale of serum, vaccines and other products used to prevent or treat diseases The father of the FDA: Harvey Washington Wiley Poison Squad of 1903: the influence of food preservatives and colors 7
8 1906: the Pure Food and Drugs Act: signed by President Theodore Roosevelt on June 30, 1906 the law that gave rise to widespread consumer protection in the US prohibits the interstate commerce of misbranded and adulterated foods and drugs 8
9 1912: Sherley s Amendment to prohibit false and fraudulent label claims of therapeutic effectiveness 1927: the Food, Drug and Insecticide Administration, which became FDA in : FD&C (aka The Act) enacted after people died from antifreeze containing drug 1951: Durham-Humphrey Amendment - OTC 1962: Kefauver-Harris Drug Amendments - Thalidomide tragedy 9
10 1970: Poison Prevention Packaging Act child-resistant packaging 1972: Over-The-Counter Review 1976: Medical Device Amendments 1983: Orphan Drug Act 1990: Safe Medical Devices Act Humanitarian Use Devices (HUD), which can be marketed under Humanitarian Device Exemption (HDE) 10
11 1992: Medical Device Amendments device tracking and post-marketing surveillance 2002: MDUFMA user fees are established; established the Office of Combination Products 2012: The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, Gives the authority to collect user fees from industry to fund reviews of innovator drugs (PDUFA V), medical devices (MDUFA III), generic drugs user fee amendments and biosimilar biological products (BsUFA); Promotes innovation to speed patient access to safe and effective products; Increases stakeholder involvement in FDA processes; and Enhances the safety of the drug supply chain. 11
12 12
13 FDA s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. Center for Drugs Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) 13
14 CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) - regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. 14
15 8 Offices Office of the Center Director Office of Management Operations Office of Compliance (OC) Office of Device Evaluation (ODE) with 7 divisions Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices (DAGRID) Division of Cardiovascular Devices (DCD) Division of Ophthalmic and Ear, Nose and Throat Devices (DOED) Division of Neurological and Physical Medicine Devices (DNPMD) Division of Orthopedic Devices (DOD) Division of Surgical Devices Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD) Office of In Vitro Diagnostic Device Evaluation and Safety with 4 divisions Office of Surveillance and Biometrics with 4 divisions Office of Science and Engineering Laboratories Office of Communication, Education and Radiation Programs 15
16 Medical Devices originally not in the scope of the FD&C Act First regulated in 1976 with the Medical Device Amendments: Medical device safety and effectiveness; 3 classes based on risk to the patient and/or the user; For once it s good to have a grandpa : the pre-amendment devices were grandfathered ; If a device was not on the market as of 28 May 1976, then the device needs to identify a predicate or grandfather to demonstrate substantial equivalence to. Intended Use concept - must be same as predicate Thus far, approximately 1,700 different generic types of devices are grouped into 16 medical specialties referred to as panels 16
17 Does the device raise new or different concerns of safety and/or effectiveness? If yes: the device would require more rigorous regulatory assessment If No: identify a predicate device and claim substantial equivalence Device Classification: Class I: thong depressors, medical gloves, pacemaker charger Class II: endoscopes, vascular catheters, guide wires Class III: heart valves, stents, pacemakers Combination products: drug eluting stents, drug coated leads, bone cement mixed with drug 17
18 Quality Systems Regulations device cgmp requirements (21 CFR part 820) First authorized by section 520(f) of the FD&C Act on July 21, 1978 (43 FR ) Effective on December 18, 1978, and was codified under part 820 Design control concept 18
19 Types of marketing submissions: 510(k) notifications (21 CFR 807) de novo (2012 FDASIA) Pre-Market Approval applications (PMAs; 21 CFR 814) Product Development Protocol (PDP, ) Humanitarian Device Exemption (HDE, 21 CFR 814) for Humanitarian Use Device Types of investigational device submissions: Investigational Device Exemption (IDE) to conduct clinical trials (21 CFR 812) 19
20 The Web: Professional Groups: RAPS DIA AdvaMed LinkedIn 20
21 You have completed a 30-minute regulatory affairs on-line training You can print this page for your records 21
22 Please us at 22
23 23
The draft of this document issued on December 27, 2011.
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff Document issued on: July 28, 2014 The draft of this
More informationkok1 UQ 510(k)J Device {Applicant 510(k) Summary (per 21 CFR 807.92(c)) OCT 2 7 2008 1. Applicant
kok1 UQ 510(k) Summary (per 21 CFR 807.92(c)) OCT 2 7 2008 1. Applicant Tech Avenue Ventures d/b/a MPowRx Health and Wellness Products Inc. #510 3553-31 St. NW Calgary, Alberta T2L 2K7 Canada Contact Person:
More informationAugust 12, 2014. Oertli Instrumente AG Ms. Karin Rohr Head of Quality Management & Regulatory Affairs Hafnerwisenstrasse 4 CH 9442 Berneck Switzerland
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service August 12, 2014 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 Oertli
More informationInformation Sheet Guidance For IRBs, Clinical Investigators, and Sponsors
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Frequently Asked Questions About Medical Devices Additional copies are available from: Office of Good Clinical Practice Office
More informationOctober 28, 2015. Cavex Holland Bv Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem, 2031CJ The NETHERLANDS
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 28, 2015 Cavex
More informationMarch 20, 2015. Dear Mr. Chen:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 March 20, 2015 Biomate
More informationMay 5, 2015. Dear Mr. Courtney:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 May 5, 2015 Terumo Cardiovascular
More informationPMAs, 510(k)s, and Advanced IDE Topics
PMAs, 510(k)s, and Advanced IDE Topics Kenneth J. Cavanaugh Jr., Ph.D. Scientific Reviewer Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health kenneth.cavanaugh@fda.hhs.gov
More informationJUN 2 6 butt. EkoSonicTM Endovascular System with Rapid Pulse Modulation
KC6, IL(6/ SPECIAL 510(k) Notification EkoSonic TM Endovascular System JUN 2 6 butt Section 4. General Provisions 510(k) Summary Submitter's Name and Address: Contact Person: Classification Name: EKOS
More informationQ(K SVJM~jPagelIof 3
K13 0460 Q(K SVJM~jPagelIof 3 JUL 1 12013 This 51 0(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k)
More informationJuly 24, 2015. Dear Ms. Rhodes:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 InnoVision, Incorporated
More information510(K) SUMMARY. 510(k) Number KOS'00-r
" iirtual Ports Virtsua Ports Virtual Ports Ltd. 510(K) SUMMARY 510(k) Number KOS'00-r MAR 2 12008 Applicant's Name: Contact Person: Trade Name: Common name: Classification: Predicate Devices: Device Description:
More information[DOCKET NO.96N-0002] DRAFT
[DOCKET NO.96N-0002] DRAFT DRAFT DOCUMENT CONCERNING THE REGULATION OF PLACENTAL/UMBILICAL CORD BLOOD STEM CELL PRODUCTS INTENDED FOR TRANSPLANTATION OR FURTHER MANUFACTURE INTO INJECTABLE PRODUCTS DECEMBER,
More informationDrug Development Process
Drug Development Process Original Arthur: Addie D. Anderson CRB Consulting Engineers, Inc. Overview Important milestones establishing our current system of regulations Step-by-step overview of the drug
More informationSECTION 5 BARDEX TEMPERATURE-SENSING FOLEY CATHETER 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
SECTION 5 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION This 5 10(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. A. SUBMITTER
More informationApril 7, 2015. Acclarent, Inc. Mr. James Patrick Garvey II Sr. Manager, Regulatory Affairs 1525-B O'Brien Drive Menlo Park, CA 94025
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 7, 2015 Acclarent,
More informationOffice of Acquisitions & Grants Services (OAGS) FDA Small Business Outreach Vendor Fair. February 19, 2014
Office of Acquisitions & Grants Services (OAGS) FDA Small Business Outreach Vendor Fair February 19, 2014 FDA Mission FDA is responsible for: Protecting the public health by assuring that foods are safe,
More informationTotal Product Lifecycle Solutions from NSF Health Sciences Medical Devices
Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices Experts in medical device quality systems, compliance, regulatory affairs, auditing and training www.nsf.org The Right People.
More information510(k) Summary. Dentsply Implants. April 30, 2013
5 1 0(k) Summary AtlantisTM Straumann Bone Level Abutment 510(k) Summary Dentsply Implants MAY 1 2013 ADMINISTRATIVE INFORMATION AtlantisTM Straumann Bone Level Abutment K130216 April 30, 2013 Manufacturer
More information510(k) SUMMARY MANI Needle and Suture Pack MANI, Inc.
510(k) SUMMARY MANI Needle and Suture Pack MANI, Inc. This 51 0(k) summary of safety and effectiveness for the MANI Needle and Suture Pack (Poly(ethylene terephthalate)) is submitted in accordance with
More informationFebruary 5, 2015. Dear Kristin Pabst,
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 5, 2015, Inc.
More informationDICOM Grid, Inc. January 25, 2016. Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 ALEXANDRIA VA 22314
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 DICOM Grid, Inc. Senior
More informationSimpler Implant Solutions Inc. 2930 Arbutus St. Vancouver, BC V6i 3Y9. haroldbergmanl~ogmail.com 604 736 9890 Telephone 604 736 9747 Fax K080115
APR 5 2013 Summary: K121281 Submitter: Company Address Contact Person: Simpler Implant Solutions Inc. 2930 Arbutus St. Vancouver, BC V6i 3Y9 Dr. Harold Bergman haroldbergmanl~ogmail.com 604 736 9890 Telephone
More informationHow to apply for Medical Device License in Taiwan
How to apply for Medical Device License in Taiwan According to Pharmaceutical Affairs Act (PAA), all medical devices regardless their classification shall apply for Medical Device License before they are
More information2. Contact Person: Garo Mimaryan, MS., RAC 7 Technical Regulatory Affairs Specialist III 3. Phone Number: (914)-524-3270
SIEM EN S Abbreviated 510(k) Premnarket Notification IMMULITE 2000 PSA Calibration Verification Material 6. 510(k) Summary as Required by 21 CFR 807.92 K( - is-1 3 (v A. 5 10(k) Number: B. Purpose for
More informationNovember 17, 2015. Nanova Biomaterials, Inc. Mr. Andrew Ritts Senior Research Scientist 3806 Mojave Ct Columbia, Missouri, 65202
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 November 17, 2015 Nanova
More informationKoqo8 go. ER35 ERO-SCAN Pro Hearing Test System. 61 Martin Lane Elk Grove Village, IL 60007. Manager of Instrumentation Products
Koqo8 go Traditional 510(k) Premarket Notification ER35 ERO-SCAN Pro Hearing Test System Page 6 3.0 510(K) SUMMARY Submission Date: March 30, 2007 Submitter Information: Company Name: Company Address:
More informationU.S. Medical Devices Market
U.S. Medical Devices Market Medical equipments represent a wide range of health care products used by physicians to diagnose and treat patients in inpatient and outpatient settings. These range from tongue
More informationORACLE CONSULTING GROUP
ORACLE CONSULTING GROUP An Official United States Agent Firm for Foreign Establishments CONSULTING MEMORANDUM: DEALING WITH A MEDICAL DEVICE IN THE U.S. 5398 Golder Ranch Rd., Ste. 1 Tucson, Arizona 85739
More informationMay 7, 2015. Tactile Systems Technology Inc Daniel Chase V.P. Engineering & Operations 1331 Tyler St NE Minneapolis, Minnesota 55413
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 7, 2015 Tactile Systems Technology Inc Daniel
More informationAugust 21, 2015. TCM Associates Ltd Mr. Iain Alligan Technical Director 3 Hillgrove Business Park Nazeing Road Essex EN9 2HB United Kingdom
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Mr. Iain Alligan Technical
More informationCombination Products Regulation in the United States
Combination Products Regulation in the United States Presenter: Scott Sardeson RAC US/EU 3M Health Care St. Paul, MN USA 1 Presentation Outline Combination products Definitions and Regulations Jurisdiction
More informationMEDICAL DEVICE REGULATIONS 2008 IEEE/PSES. Frank Eng Investigator FDA, San Jose, CA Email: frank.eng@fda.hhs.gov
MEDICAL DEVICE REGULATIONS 2008 IEEE/PSES Frank Eng Investigator FDA, San Jose, CA Email: frank.eng@fda.hhs.gov 1 Disclaimer The contents of this presentation are my own, and do not necessarily reflect
More informationAW Server 510 (k) Summary of Safety and Effectiveness
SEP 2 2008 GE Medical Systems AW Server 510 (k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR
More informationGE Healthcare MAR 1 2013
K130155 Pagel1 of 2 GE Healthcare MAR 1 2013 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Submitter: Primary Contact Person: Secondary Contact Person:
More informationUniversity of Texas Medical School at Houston. April 14, 2015
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 University of Texas Medical
More informationUnique Device Identifier System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff
Unique Device Identifier System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff Document issued on August 20, 2014. On November 5, 2014 this document was
More informationFDA Review Patterns of De Novo Submissions
FDA Patterns of De Novo Submissions June 2010 1 FDA Patterns of De Novo Submissions Zvi Ladin, PhD, Principal, Boston MedTech Advisors 1 Michael Imhoff, MD PhD, Managing Director, Boston MedTech Advisors
More informationFEB 2 2 2007. Mr. Gordon J. Peters Director Regulatory Compliance DocuSys, Incorporated 820 S. University Boulevard, Suite 3-H Mobile, Alabama 36609
FEB 2 2 2007 510(k) Summary DocuSys Inc. Anesthesia Information and digital-drug Management System The following information is in accordance with 21 CFR 807.92 Submitter's Name, Address, Telephone Number,
More information510(k) Summary of Safety and Effectiveness JUN 1 62009. Hip prosthesis
V)O9pttot L~~(g 510(k) Summary of Safety and Effectiveness JUN 1 62009 Proprietary Name: Common Name: Rejuvenate Monolithic Size 4 Hip Stem Hip prosthesis Classification Name and Reference: Hip joint metal/ceramic/polymner
More information0 EC2 92011 V-,) 133 Lj9a
0 EC2 92011 V-,) 133 Lj9a Section 5: 5 1 0(k) Summar 5 10(K) SUMMARY FOR SOMATOM DEFINITION Flash (with Stellar Detector) Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern,
More informationUltimate Concepts Inc.
MAR 2 3 2004 Ultimate Concepts Inc. 7835 South 1300 East Sandy, Utah 84094 Phone 800-682-3241 or 801-566-3214 SUMMARY Submitter's name: Address: Ultimate Concepts, Inc. 7835 South 1300 East Sandy, Utah
More informationJanuary 12, 2016. Dear Amy Yang:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 12, 2016 Amy
More informationI~r it NOV 72012. SIE T AENCORE Tongue Suspension System OCE 1 --. L_ August 3,2012. 510(k) Summary. Appendix 3:
I~r it NOV 72012 510(k) for the Siesta Medical, Inc.1 SIE T AENCORE Tongue Suspension System OCE 1 --. L_ August 3,2012 Appendix 3: 510(k) Summary General Company Infomto Name: Contact: Siesta Medical,
More informationMedical & Surgical Devices for Children: MDUFA IV Public Meeting. July 13, 2015. Tamar Magarik Haro Associate Director Dept. of Federal Affairs
Medical & Surgical Devices for Children: MDUFA IV Public Meeting July 13, 2015 Tamar Magarik Haro Associate Director Dept. of Federal Affairs American Academy of Pediatrics The American Academy of Pediatrics
More informationBrainreader ApS February 4, 2015 C/O Mette Munch QA Consultant Skagenvej 21 Egaa, 8250 DENMARK
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Brainreader ApS February
More informationFebruary 22, 2015. Life Spine, Incorporated Mr. Randy Lewis General Manager 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 February 22, 2015 Life Spine, Incorporated Mr. Randy
More informationEM EkGO @ GR.OUF DIPLOMAT. OT39?1 Company Name: 5. 510(K)SUMMARY Oc. Submission Correspondent. Emergo Group, Inc. Company Address:
EM EkGO @ GR.OUF DIPLOMAT 5. 510(K)SUMMARY Oc Submission Correspondent OT39?1 Company Name: Emergo Group, Inc. Company Address: 816 Congress Avenue Suite 1400 Austin, TX 78701 Company Contact: Stuart R.
More information510(K) SUMMARY [as required by section 807.92(c)] FLIGHT 60 Ventilator 510(k) Number K IaO?2Z, JUL 6 2012
510(K) SUMMARY [as required by section 807.92(c)] FLIGHT 60 Ventilator 510(k) Number K IaO?2Z, JUL 6 2012 Date Prepared: March 7, 2012 Applicant's Name: Flight Medical Innovations Ltd. 13 Hamelacha Street
More informationMViAKIO. V.A hn2 ATTACHMENT I 610(K) SUMMARY. Submitter:
MViAKIO SURGICGAL CCWRP2 V.A hn2 ATTACHMENT I 610(K) SUMMARY Submitter: MAKO Surgical Corp. Address: 2555 Davie Road, Fort Lauderdale, FL, 33317 Phone number: 954-927-2044 x. 605 Fax number: 954-927-0446
More informationMedical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance
Medical Product Development and FDA Regulations IEEE Orange County Computer Society March 27, 2006 Carl R. Wyrwa Medical Product Development and FDA Regulations Introduction Regulated FDA Overview Medical
More informationD I Z1. 510(k) Summary. Section 5. Siemens Medical Solutions USA, Inc. Oncology Care Systems. Date Prepared: September 09, 201 0.
Section 5 D I Z1 510(k) Summary Date Prepared: September 09, 201 0 Submitter: Contact: Siemens Medical Solutions USA, Inc. 4040 Nelson Avenue Concord, CA 94520 Christine Dunbar Senior Regulatory Affairs
More informationDental Morelli Ltda.
K Dental Morelli Ltda. JAN 82014 OR TOOON tia SECTION 7 510(k) SUMMARY Proprietary Name Orthodontic Miniscrew for Absolute Anchorage Date Prepared December 1, 2013 Submitter Official Contact DENTAL MORELLI
More information13. 510(k)Suminary k121917-0
Hsiner Multiple CPAP Device 510(k) Submission JL1621 13. 510(k)Suminary k121917-0 In accordance with 21 CFR section 807.92 Hsiner is submitting the following 5 10(k) summary. 13.1. Date: 07/11/2012 13.2.
More information2014 Annual Report on Inspections of Establishments
2014 Annual Report on Inspections of Establishments Table of Contents Introduction... 2 Data Collection and Definitions... 3 Section 510(h)(6)(A)(i) Number of Domestic and Foreign Establishments Registered
More informationWhat Does Having a FDA Cleared Pregnancy Test Mean?
What Does Having a FDA Cleared Pregnancy Test Mean? Clinical Trials Transformation Initiative (CTTI) July 15-16, 2013 Denise N. Johnson-Lyles, Ph.D. Toxicology Branch Chief Division of Chemistry and Toxicology
More informationDEC 2 2 2005. The three components of the Axxent Electronic Brachytherapy System include the Controller, Balloon Applicators-BR and X-ray Source.
DEC 2 2 2005 Xoft, Inc. Fremont, California Premarket Notification March 31, 2005 II. 510(k) Summary A. Name of Device Trade name: AxxentTM Electronic Brachytherapy System Common name: X-Ray Radiation
More informationSection 5-510(k) Summary. This document is provided in the following pages. DEC 2 92010
Section 5-510(k) Summary This document is provided in the following pages. DEC 2 92010 DC221 510(k) SUMMARY This summary of 5 10(k) safety and effectiveness information is being submitted in accordance
More informationGuidance for Industry and Food and Drug Administration Staff
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff Document
More informationSUMMARY OF SAFETY AND EFFECTIVENESS for Powered Muscle Stimulator
SUMMARY OF SAFETY AND EFFECTIVENESS for Powered Muscle Stimulator 510(k) NUMBER: K071320 AUG 72007 DATE OF May 3, 2007 SUBMISSION: SUBMITTER: ESTABLISHMENT REGISTRATION NO: 3004753827 EVERLIFE MEDICAL
More informationMay 22, 2015. Rachel s Remedies, LLC Mrs. Rachel E. Jackson 2316 Delaware Ave. #174 Buffalo, New York 14216
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 May 22, 2015 Rachel s
More informationApril 3, 2015. Dear Autumn Liu,
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 3, 2015 Shenzhen
More informationAd-tech Medical Instrument Corporation. Principal Consultant Quality & Regulatory Associates, LLC. 800 Levanger Lane. Stoughton, Wisconsin 53589
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service March 4, 2016 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Ad-tech
More informationFDA s Final Compliance Policy Guide for Marketed Unapproved Drugs Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle
FDA s Final Compliance Policy Guide for Marketed Unapproved Drugs Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle Kurt R. Karst Associate Hyman, Phelps & McNamara, P.C. 700 Thirteenth
More informationLewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279
510(k) Summary i '\' Submitted by Contact Person: EZ-Blocker B.V. Delftechpark 26 Delft 2628 XH 2, The Netherlands6911 Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279
More informationOCT 18 20U5Ibko. a. Submitter Name: Cosmetic Dental Materials Inc. (CDM Inc.) b. Submitter Address: 812 Water St. NE Albany OR 97321
OCT 18 20U5Ibko Cosmetic Dental Materials QuickSmile Whitening Light Original Premarket 5 10(K) Notification SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS This 5 10O(K) summary of safety and effectiveness
More informationBuilding 6, Suite 300 RyeBrook, NY 10573 C-ontact-N~ame: --- William H-. Schofield Director of TeleHealth Operations. Signal,_Radiofrequency
Optimealth Care Solutions, Inc. Traditional.51/0(k) Opion Telel-ealib Application 510(k) Summary: K130971 Manufacturer Name: Optum Health Care Solutions, Inc. Address:T1oo King Street Building 6, Suite
More information5.0 510 (k) SUMMARY DEC 18 2012
ATTACHMENT 3 Page 1 of 2 5.0 510 (k) SUMMARY DEC 18 2012 A. Submitted by:... *Submitters name and address: Skepipsbron 44 111 30 Stockholm Sweden *Submitters telephone number Phone: +468 190325 Cell: +46
More informationRefuse to Accept Policy for 510(k)s. Guidance for Industry and Food and Drug Administration Staff
Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration Staff Document issued on: December 31, 2012 This document supersedes Center for Devices and Radiological Health
More information510(k) Summary. Atlanti STM Abutment and AtlantisTM Crown Abutment in Zirconia for Dentsply Ankylos Implant
/p(so 3 Premarket Notification SectionS5: Page - 4 JUL 5 2012 510(k) Summary Astra Tech Inc. Atlantisim Abutment and Atlantis~m Crown Abutment in Zirconia for Dentsply Ankylos Implant ADMINISTRATIVE INFORMATION
More informationL~l t l V~! MAY 23 200?
L~l t l V~! MAY 23 200? 510 (k) Summay (As required by 21 CFR 807.92 and 21 CFR 807.93) NAME OF SPONSOR: 510(K) CONTACT: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment
More informationGuidance for Industry
Guidance for Industry Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) DRAFT GUIDANCE
More informationInformation Sheet Guidance For IRBs, Clinical Investigators, and Sponsors
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Institutional Review Board Inspections Additional copies are available from: Office of Good Clinical Practice Office of Special
More information510(k) SUMMARY. OPTION-vyM Urinary Catheter
510(k) SUMMARY OPTICON MEDICAL, INC. OPTION-vyM Urinary Catheter Submitter s Name and Contact Information Opticon Medical, Inc. 7001 Post Road, Suite 100 Dublin, OH 430 16 Primary Contact: Glenn D. Brunner,
More informationRAPS ONLINE UNIVERSITY
RAPS ONLINE UNIVERSITY Practical education and training for business success. For regulatory professionals, there is only one name to know and trust for online education and training RAPS Online University.
More informationFDA Regulation of Hearing Aids. Eric A. Mann, MD, PhD Clinical Deputy Director Division of Ophthalmic and ENT Devices ODE/CDRH/FDA
FDA Regulation of Hearing Aids Eric A. Mann, MD, PhD Clinical Deputy Director Division of Ophthalmic ENT ODE/CDRH/FDA U.S. Food Drug Administration Presentation Outline Overview of device regulations riskbased
More information870.2900,11 DSA Cable, transducer and VS3, VS4 electrode, patient connector
510K Summary JUN 2 62014 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807-92(c). 1. The
More informationU.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION TRIBAL CONSULTATION POLICY (DRAFT) Table of Contents
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION TRIBAL CONSULTATION POLICY (DRAFT) Table of Contents 1. Background and Purpose 2. Tribal Sovereignty 3. Policy 4. Background on
More informationJUL 2 2008. Ms. Kendra Basler Regulatory Affairs Associate Abbott Vascular Cardiac Therapies 3200 Lakeside Drive Santa Clara, CA 95054-2807
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service JUL 2 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Kendra Basler Regulatory Affairs Associate Abbott Vascular
More informationsbchoi~kku.edu jeremy~sooil.com DANA Diabecare IlS Insulin Infusion pump Infusion pump Class II
510(k) Summary for DANA Diabecare IS SPONSOR SOOIL Development Co, Ltd. 196-1, Dogok-dong, Kangnam-gu Seoul 135-270 Korea 2 2007 Contact Person: Soo Bong Choi Telephone: 82-2-3463-0041 Fax: 82-2-3463-7077
More informationUNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY
JOYCE R. BRANDA Acting Assistant Attorney General JONATHAN F. OLIN Deputy Assistant Attorney General Civil Division U.S. Department of Justice PAUL J. FISHMAN United States Attorney District of New Jersey
More information51O(K) SUMMARY: V.A.C@ Therapy family of devices.
51O(K) SUMMARY: V.A.C@ Therapy family of devices. I. Name of Device: V.A.C.@ ATSTM, mini V.A.C.@, V.A.C. 8 FreedomTM 11. Classification Name: Powered Suction Pump 21 CFR 878.4780 III.510(k) Applicant:
More informationGuidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
Reprinted from FDA s website by EAS Consulting Group, LLC Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products DRAFT GUIDANCE This guidance document
More informationNi Hau Industrial Co., Ltd. Ms. Lyn Chiu Sales Manager No. 15, Alley 125, Lane 318, Section 2, An Ho Road Tainan City, Taiwan 70967
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 7, 2015 Ni Hau Industrial
More informationPhoenix Thera-Lase Systems, LLC Ms. Diane Rutherford Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 Phoenix Thera-Lase Systems,
More informationFDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts
FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts Clinical Laboratory Improvement Advisory Committee Meeting Centers for Disease Control and Prevention February 15, 2012 Tremel A. Faison,
More informationJune 9, 2015. Stryker Corporation Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 Stryker Corporation Garry
More informationNovember 20, 2014. Vascular Flow Technologies Ltd. Edwin Lindsay VP of QA/RA Prospect Business Centre, Gemini Cresent Dundee DD2 1TY United Kingdom
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 20, 2014 Vascular
More informationOctober 29, 2015. Dear Ms. Hartnett:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 October 29, 2015 Ivoclar
More informationDatrix, Inc NOV - 1 2005. Appendix G. 510(k) Summary of Safety and Effectiveness for Datrix, Inc CardioServer ECG Management System
Appendix G NOV - 1 2005 510(k) Summary of Safety and Effectiveness for CardioServer ECG Management System 1. DATE SUMMARY PREPARED: 9-26-2005 2. SUBMITTER'S NAME AND ADDRESS: Linda Gluckman 340 State Place
More informationGuidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationMarch 3, 2015. Dear Ms. Alice Gong,
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Jiangsu Ideal Medical
More informationCDRH Regulated Software
CDRH Regulated Software An Introduction John F. Murray Jr. CDRH Software Compliance Expert CDRH Regulates Software in the following areas Medical Devices Automation of Production Systems Automation of
More informationSarah Chandler A/Head, Regulatory and Scientific Section Medical Devices Bureau sarah.chandler@hc-sc.gc.ca
Software Regulated as a Medical Device Sarah Chandler A/Head, Regulatory and Scientific Section Medical Devices Bureau sarah.chandler@hc-sc.gc.ca Therapeutic Products Directorate Director General S. Sharma
More informationBMR ~131o-lvleccai Kesearcn Ltd.
BMR ~131o-lvleccai Kesearcn Ltd. Parkmnore Business Park West, Galway, Ireland Tel: +353 (0)91 774300 - Fax: +353 (0)91 774301 6 4& This summary is being submitted in accordance with the requirements of
More informationReport to Congress. Food and Drug Administration Safety and Innovation Act of 2012 Section 1131
Report to Congress Strategic Integrated Management Plan for the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological
More informationWhat is a medical device? Medical Devices: Roadmap to Market. Kathryn Klaus, Esq.
Medical Devices: Roadmap to Market Kathryn Klaus, Esq. The last installment of Regulatory 360 discussed the FDA organization in general where it came from and a broad overview of how it operates, as well
More information21st Century Cures Act: Key Provisions Related to Medical Devices
21st Century Cures Act: Key Provisions Related to Medical Devices July 30, 2015 Food & Drug The 21st Century Cures Act ( the Act or HR 6 ) was passed by the House of Representatives on July 10, 2015, by
More informationBreakthrough Therapy Program U.S. Food and Drug Administration (FDA)
Breakthrough Therapy Program U.S. Food and Drug Administration (FDA) Presentation before the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) Jarilyn Dupont,
More information510(k) SUMMARY APR 2 9 2009. Date: 15 th December 2008
Traditional 510(k) COOK Sydney IVF Vitrification & Warming Media APR 2 9 2009 510(k) SUMMARY Date: 15 th December 2008 Submitted By: Ms Milica Talic QA/RA Manager Cook Australia 12 Electronics Street Brisbane
More information