In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. Office of Science and Engineering Laboratories For questions regarding the use or interpretation of this guidance contact James Norman at 301-827-4380. 10903 New Hampshire Avenue 71, Rm. 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. Center for Devices and Radiological Health Office of Communication and Education Digital Communication Media Staff 16071 Industrial Drive, HFZ-260 … WO66-5431 The site is secure. The .gov means it’s official.Federal government websites often end in .gov or .mil. The CDRH is responsible for regulating firms who manufacture, repackage, relabel and/or import medical devices sold in … WO32-5245 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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). G609, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002 ATTN: IMDRF ToC Pilot Submission. 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. Phone: 301-796-5900. WO66-5441 Office of the Center Director Sincerely yours, Mary S. Pastel, ScD Deputy Director for Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices Start a free trial now to save yourself time and money! OMB control number: 0910-0607 Expiration Date: 09/30/2010 See additional PRA statement in Section 4 of this guidance. 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. 10903 New Hampshire Avenue This number is referred to as the “document control number,” “510(k) number,” or just “K number”. 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." 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. Center for Devices and Radiological Health You may also leave a voicemail message at 240-276-3357 and we will return your call as soon as possible. Before a radiation-emitting device can be approved by the FDA, its manufacturer must maintain records of the product’s specifications and capabilities and file reports about the product with the FDA’s Center for Devices and Radiological Health (CDRH). Silver Spring, MD 20993-0002, U.S. Food & Drug Administration Office of the Center Director Center for Devices and Radiological Health 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 WO66-5429 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. 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 An official website of the United States government, : WO62-3214 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. For questions regarding this document, contact Carol Benson at 240-276-0396 or by e-mail at carol.benson@fda.hhs.gov. Silver Spring, MD 20993-0002, U.S. Food & Drug Administration The cover letter and media should be sent via mail to the Document Control Center (DCC) to: Food and Drug Administration, Center for Devices and Radiological Health, Document Control Center, Bldg. Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or 301-796-8118 CDRH PREMARKET REVIEW SUBMISSION COVER SHEET - njpa instantly with SignNow. 10903 New Hampshire Avenue ... broker’s name and phone number will assist FDA in contacting the appropriate point of contact if there are any discrepancies with the line/entry. Office of Surveillance and Biometrics This complexity categorization Jeff Shuren, director of the US FDA’s device center, says the agency is drafting a guidance document that will give industry recommendations on how it should handle products granted emergency use authorization during the COVID-19 public health emergency, once it’s over. Gaithersburg, MD 20877 Center for Devices and Radiological Health US FDA/CDRH: FDA Preliminary Public Health Notification: ... by phone 1-800-FDA-1088, or by returning the postage- ... at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. For more specific information including emails and phone numbers see the CDRH Management Directory by Organization. 2 About CDHR Informatics Staff ... • Coordinate with Agency and Center Initiatives ... • Device Model Number 10903 New Hampshire Avenue 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). U.S. Food & Drug Administration Comments may not be acted upon by the Agency until the document is next revised or updated. 10903 New Hampshire Avenue 10903 New Hampshire Avenue 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. ... Center for Devices and Radiological Health Food and Drug Administration Nancy Stout, Ed.D. Document issued on: May 7, 2008 The draft of this document was issued on August 14, 2000. Find them by name, phone number, email, etc. Start a … WO66-1677 Center for Devices and Radiological Health FDA CDRH Informatics Update Terrie Reed Associate Director, Informatics 10/6/2010. CDRH, FDA, Guidance, Labeling, Medical Devices FDA On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. Center for Devices and Radiological Health The guidance will also address already-approved devices that were modified by their makers under enforcement discretion. 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. External individuals (submitter points of contact) who have concerns may contact FDA or CDRH by phone, mail or email using the contact information provided on fda.gov. Furthermore, CDRH assures that patients and providers have timely and continued access to high-quality, safe, and effective medical devices. Fill out, securely sign, print or email your FORM FDA 3514 (1/13). Upon receipt in the CDRH Document Mail Center (DMC) located within ODE, 510(k) submissions are date stamped and logged into the DMC computer database where a unique control number is assigned to the document. The .gov means it’s official.Federal government websites often end in .gov or .mil. Silver Spring, MD 20993-0002, U.S. Food & Drug Administration Fill out, securely sign, print or email your Attachment E CDRH Final Guidance Cover Sheet - FDA instantly with SignNow. Questions? Fda3514. 66, Rm. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. Attachment-> : FDA … docket number listed in the notice of availability that publishes in the Federal Register. Center for Devices and Radiological Health 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 releases mission statement describing the center's statutorily mandated activities the week of Dec. 13. 10903 New Hampshire Avenue Center for Devices and Radiological Health 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_ Available for PC, iOS and Android. Office of Communication and Education The FDA also issues accession numbers to reports on electronic products. Phone: 301-348-1474, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Office of Science and Engineering Laboratories, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, Office of Communication and Education - Division of Communication Media, CDRH Management Directory by Organization. 16071 Industrial Drive, HFZ-260 Silver Spring, MD 20993-0002, U.S. Food & Drug Administration Silver Spring, MD 20993-0002, Food & Drug Administration G335, 10903 New Hampshire Ave. Silver Spring, MD 20993-2000. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For specific phone numbers and email addresses for each office, division, and branch, see the CDRH Management Directory by Organization. Digital Communication Media Staff The most secure digital platform to get legally binding, electronically signed documents in just a few seconds. The site is secure. Office of Communication and Education Before sharing sensitive information, make sure you're on a federal government site. Office of Management Operations CDRH is responsible for helping to ensure the safety and effectiveness of medical devices marketed in the United States. FDA personnel may raise concerns through the FDA's Employee Resource and Information Center (ERIC) via phone or email. Document Control Center, Bldg. 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… Center for Devices and Radiological Health, Recalls, Market Withdrawals and Safety Alerts, Office of Science and Engineering Laboratories, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, CDRH Management Directory by Organization, CDRH Mailing Addresses and Office Phone Numbers, Addresses for Electronic Product Radiation Control Reports and Recordkeeping. Before sharing sensitive information, make sure you're on a federal government site. WO66-5410 Available for PC, iOS and Android. 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. 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