CDRH PREMARKET REVIEW SUBMISSION COVER SHEET - njpa instantly with SignNow. WO66-5431 Center fot Devices and Radioloøca.l Health Office of Device Evaluation Document Center (HFZ401) 9200 Corporate Boulevard Rockville, Maryland 20850 Atm: 510(k) Document Mail Center Re: Clear- Vu TM Minimally Invasive Devices, LLC Sincerely, Michael H. Southworth, RAC Principal & Senior Consultant FDA CDRH DMc Received 32 FDA's Center for Devices and Radiological Health has eight offices that cover the total product lifecycle of regulated medical devices and radiation-emitting products. WO66-1677 Start a free trial now to save yourself time and money! Office of Communication and Education For 2016-2017, CDRH has identified Partnering with Patients and Promoting a Culture of Quality and Organizational Excellence as strategic priorities, specifically having the perspective of our stakeholders and understanding implementation of t… Attachment A CDRH Draft Guidance Document Standard Operating Procedures (SOP’s) Conformance to FDA Good Guidance Practices (GGP’s) Checklist for LEVEL 1 Compliance Program Guidance Manual: Inspection of Medical Devices__ Contact [Name, mail stop and phone number]: Wes Morgenstern, HFZ-305 (301) 594-4695_ Center for Devices and Radiological Health On November 18th, 2013 the Food and Drug Administration (FDA) announced that it restructured the Center for Devices and Radiological Health’s (CDRH) Office of Compliance (OC). 2 About CDHR Informatics Staff ... • Coordinate with Agency and Center Initiatives ... • Device Model Number Before sharing sensitive information, make sure you're on a federal government site. Sincerely yours, Mary S. Pastel, ScD Deputy Director for Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices 10903 New Hampshire Avenue Office of Management Operations The site is secure. Gaithersburg, MD 20877 Fill out, securely sign, print or email your Attachment E CDRH Final Guidance Cover Sheet - FDA instantly with SignNow. 10903 New Hampshire Avenue CDRH (Center for Devices and Radiological Health) is providing a free online educational tool with training modules that describe "many aspects of medical device and radiological health regulation [that cover] both premarket and postmarket issues." Rockwell Laser Industries offers a complete assistance package for manufacturers of laser products in completing the required laser and laser product initial reports as mandated by the Federal Laser Product Performance Standard (21 CFR Parts 1040.10 and 1040.11).RLI will review with the client all aspects required for classification and certification relative to the FDA/CDRH requirements. Smith by internet electronic mail at lds@cdrh.fda.gov or by phone at (301)796-5868 or Woody Strzelecki at (301) 796-6939 or by internet electronic mail at Woody.Strzelecki@fda.hhs.gov . Center for Devices and Radiological Health Office of Communication and Education Digital Communication Media Staff 16071 Industrial Drive, HFZ-260 … Office of Communication and Education  An official website of the United States government, : 16071 Industrial Drive, HFZ-260 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). For the medical device industry, it's not always easy to understand and correctly implement FDA regulations. 10903 New Hampshire Avenue Office of the Center Director WO66-5429 Registration Number FDA/CDRH prefers to use FEI numbers for identifying the Entity for Medical ... Telephone Number, Fax Number, and Email address. The site is secure. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes and Device Problem Codes, are maintained in the National Cancer Institute (NCI) thesaurus (NCIt). This number is referred to as the “document control number,” “510(k) number,” or just “K number”. Comments may not be acted upon by the Agency until the document is next revised or updated. Office of Surveillance and Biometrics 10903 New Hampshire Avenue Office of the Center Director WO66-5441 Document Mail Center - WO66-G609 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 ... December 16, 2011 W a i v e r G r a n t e d N o t i f i c a t i o n The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) ... with a letter to FDA referencing the document number above. WO66-5410 For questions regarding this document, contact Carol Benson at 240-276-0396 or by e-mail at carol.benson@fda.hhs.gov. CDRH is responsible for helping to ensure the safety and effectiveness of medical devices marketed in the United States. World's only full-text search for FDA employees. Find them by name, phone number, email, etc. Document Control Center, Bldg. Center for Devices and Radiological Health FDA's Center for Devices and Radiological Health has eight offices that cover the total product lifecycle of regulated medical devices and radiation-emitting products. Center for Devices and Radiological Health If you have questions about the eCopy program, please contact the CDRH eCopy Program Coordinators at CDRH-eCopyinfo@fda.hhs.gov or 240-402-3717. In his five years as CDRH director, Schultz superintended more than a few processes in the center that might be similarly described by the people they affected. G335, 10903 New Hampshire Ave. Silver Spring, MD 20993-2000. Center for Devices and Radiological Health WO62-3214 Office of Science and Engineering Laboratories Silver Spring, MD 20993-0002, U.S. Food & Drug Administration 71, Rm. Any information to be submitted to FDA regarding this HOE should be submitted in triplicate, unless otherwise specified, to the address below and should reference the above HOE number to facilitate processing: Document Mail Center (HFZ-401) Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration Center for Devices and Radiological Health Fda3514. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. G609, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002 ATTN: IMDRF ToC Pilot Submission. Office of Device Evaluation You may also leave a voicemail message at 240-276-3357 and we will return your call as soon as possible. Silver Spring, MD 20993-0002, Food & Drug Administration Center for Devices and Radiological Health This complexity categorization Silver Spring, MD 20993-0002, U.S. Food & Drug Administration Seek medical attention immediately if you experience any side effects and report it to FDA at [email protected] or via online reporting through our website: www.fda.gov.ph. The guidance will also address already-approved devices that were modified by their makers under enforcement discretion. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118 The .gov means it’s official.Federal government websites often end in .gov or .mil. ... Center for Devices and Radiological Health Food and Drug Administration Nancy Stout, Ed.D. Fill out, securely sign, print or email your FORM FDA 3514 (1/13). Digital Communication Media Staff The CDRH is responsible for regulating firms who manufacture, repackage, relabel and/or import medical devices sold in … FDA OKed Email Monitoring of CDRH Scientists, Senator Says July 23, 2012 Lawmakers and watchdog groups are putting a brighter spotlight on the FDA, demanding the agency, HHS and the White House take action to ensure whistleblower protections and investigate allegations of inappropriate email monitoring by the drug regulator. Document issued on: May 7, 2008 The draft of this document was issued on August 14, 2000. Before sharing sensitive information, make sure you're on a federal government site. Available for PC, iOS and Android. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, ... or by e-mail at phann@cdrh.fda.gov. Contact James Norman at 301-827-4380 COVER the total product lifecycle of regulated medical devices and Health... Https: // ensures that you are connecting to the fda cdrh document mail center phone number website and that any information provide... 4 of this document, contact Carol Benson at 240-276-0396 or by at. 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