FDA Medical Devices Division 2019



AARP health insurance plans (PDF download)

Medicare replacement (PDF download)

medicare benefits (PDF download)

medicare coverage (PDF download)

medicare part d (PDF download)

medicare part b (PDF download)

FDA Medical Devices Division 2019

PDF download:

Center for Devices and Radiological Health (CDRH) Appeals … – FDA

www.fda.gov

Jul 2, 2019 … As of August 1, 2019, this document supersedes “Medical Device ….. DHT
Division Director, so a request for an appeal would be directed to the …

GE Healthcare July 29, 2019 GE Medical Systems SCS Nicole … – FDA

www.accessdata.fda.gov

Jul 29, 2019 … enactment date of the Medical Device Amendments, or to devices that have …
Division of Industry and Consumer Education (DICE) to ask a …

June 12, 2019 BraveHeart Wireless, Inc. Thomas Schorre … – FDA

www.accessdata.fda.gov

Jun 12, 2019 … enactment date of the Medical Device Amendments, or to devices that have …
Division of Industry and Consumer Education (DICE) to ask a …

AI/ML – FDA

www.fda.gov

Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device ….
Developing a Software Precertification Program: A Working Model; v1.0 –
January 2019: ….. Contact the appropriate review division to obtain concurrence
that the …

July 19, 2019 Siemens Medical Solutions USA, Inc. Ms … – FDA

www.accessdata.fda.gov

Jul 19, 2019 … enactment date of the Medical Device Amendments, or to devices that have …
Division of Industry and Consumer Education (DICE) to ask a …

June 25, 2019 Surgnova Healthcare Technologies (Zhejiang … – FDA

www.accessdata.fda.gov

Jun 25, 2019 … enactment date of the Medical Device Amendments, or to devices that have …
Division of Industry and Consumer Education (DICE) to ask a …

June 20, 2019 Paonan Biotech Co., Ltd. North Zhong … – FDA

www.accessdata.fda.gov

Jun 20, 2019 … enactment date of the Medical Device Amendments, or to devices that have …
Division of Industry and Consumer Education (DICE) to ask a …

July 17, 2019 Tornier Inc. Renee Stoffel Principal Regulatory … – FDA

www.accessdata.fda.gov

Jul 17, 2019 … enactment date of the Medical Device Amendments, or to devices that have …
Division of Industry and Consumer Education (DICE) to ask a …

June 27, 2019 Rochal Industries, LLC William Coulston … – FDA

www.accessdata.fda.gov

Jun 27, 2019 … enactment date of the Medical Device Amendments, or to devices that have …
Division of Industry and Consumer Education (DICE) to ask a …

May 31, 2019 PENTAX Medical, A Division of PENTAX of … – FDA

www.accessdata.fda.gov

May 31, 2019 … We have reviewed your Section 510(k) premarket notification of intent to market
the device referenced above and have determined the device …

May 23, 2019 Erbe USA, Inc. John Tartal Director of Quality … – FDA

www.accessdata.fda.gov

May 23, 2019 … enactment date of the Medical Device Amendments, or to devices that have been
… Additionally, you may contact the Division of Industry and.

Silony Medical GmbH June 13,2019 Ms. Meredith May Vice … – FDA

www.accessdata.fda.gov

Jun 13, 2019 … enactment date of the Medical Device Amendments, or to devices that have …
Division of Industry and Consumer Education (DICE) to ask a …

Regulatory Education for Industry (REdI) Annual Conference … – FDA

www.fda.gov

May 29, 2019 … May 29-30, 2019 | Revere Hotel – Boston, MA … Division 1 | Office of Medical
Devices and Radiological Health Operations and New England …

Attachment B CDRH Draft Guidance Cover Sheet – FDA

www.fda.gov

Aug 2, 2019 … Division of Applied Mechanics at (301) 796-2501. When final, this … Addressing
Hazards for Medical Devices in the MR Environment. 5. Magnetically ….
Submission Program” guidance issued May 7, 201917. 120. 121.

April 4, 2019 Medtronic Sofamor Danek USA, INC. Ankit Shah … – FDA

www.accessdata.fda.gov

Apr 4, 2019 … April 4, 2019 … enactment date of the Medical Device Amendments, or to devices
… Additionally, you may contact the Division of Industry and.

Medical Device User Fee Small Business Qualification – FDA

www.fda.gov

Aug 1, 2018 … This document supersedes “FY 2018 Medical Device User Fee Small Business …
this document regarding CDRH-regulated devices, contact CDRH's Division …. E.
Important Note for Submitters of Pre-FY2019 Small Business …

Attachment E CDRH Final Guidance Cover Sheet – FDA

www.fda.gov

Document issued on April 19, 2019. You should submit comments and … For
questions about this document, contact the Division of Applied Mechanics at (301
) 796-2501, or … CDRH-Guidance@fda.hhs.gov to receive a copy of the
guidance.

March 29, 2019 BTL Industries, Inc. Mr. David Chmel VP of … – FDA

www.accessdata.fda.gov

Mar 29, 2019 … enactment date of the Medical Device Amendments, or to devices that have been
… Additionally, you may contact the Division of Industry and.