Medical Devices and Radiological Health FY2015 Program Alignment Action Plan

Ajit Basrur

Staff member
Admin
#1
The following Medical Devices and Radiological Health FY2015 Action Plan (the Action Plan), developed by the Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs (ORA) is intended to facilitate increased operational and program alignment as FDA transitions to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, and well-designed and coordinated implementation. Core elements of the Action Plan include increased specialization and de-layered management structures and processes involving ORA and CDRH, jointly developed training programs, new work planning processes, strategic enforcement approaches with aligned and updated compliance programs and policy, strategic import approaches, laboratory optimization, and improved information technology systems. Coordination of internal and external communication on the Action Plan will ensure that FDA speaks with one voice on the policies and operations related to the medical device and radiological health program. This Action Plan has been reviewed by CVM to ensure alignment with respect to veterinary devices and products.

http://www.fda.gov/AboutFDA/CentersOffices/ucm417015.htm

.
 

Attachments

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Medical Devices Shelf Life ---INDIA Other Medical Device Regulations World-Wide 3
JoCam Warranty of Medical Devices EU Medical Device Regulations 2
R Obsolesce medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational UK - Medicines and Medical Devices Bill 2019-21 Other Medical Device Regulations World-Wide 0
S Call it refurbish or not? Medical Devices Manufacturing and Related Processes 2
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
G Accelerated stability of medical devices Other Medical Device Related Standards 1
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
dgrainger Informational Parliament to vote on postponing new requirements for medical devices -17th April Medical Device and FDA Regulations and Standards News 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
M Special Controls and Class II Medical Devices Medical Device and FDA Regulations and Standards News 18
dgrainger Informational Have your say on the UK's Medicines and Medical Devices Bill Medical Device and FDA Regulations and Standards News 0
L Packaging unsterile medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
R Expected life span of Medical devices - X-Ray based diagnostic medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
Marc Medical device vulnerability highlights problem of third-party code in IoT devices Other Medical Device and Orthopedic Related Topics 1
J UK Medicines and Medical Devices Bill - 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
dgrainger Informational UK's new Medicines and Medical Devices Bill Medical Device and FDA Regulations and Standards News 0
O Is it mandatory for Medical Devices to work properly after dielectric strength tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
S IVF medical devices standards and test methods Medical Device and FDA Regulations and Standards News 4
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
M Selling Medical Devices in Puerto Rico US Food and Drug Administration (FDA) 3
J Searching Registered Medical Devices in Argentina Other Medical Device Regulations World-Wide 0
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
Watchcat Impact of MDR on Availability of Medical Devices in EU EU Medical Device Regulations 5
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
J Integrity of electronic digital records - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
Ronen E Legal counselling and Medical Devices Regulatory Affairs Other Medical Device Regulations World-Wide 2
S Service record requirements for Non-Serviceable Medical Devices CE Marking (Conformité Européene) / CB Scheme 1
T Coating of Medical Devices Other Medical Device and Orthopedic Related Topics 1
N CE marking colour for Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
F Label work instruction - Medical Devices Manufacturing and Related Processes 1
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
M Informational From RAPS – Danish Medicines Agency Ramps Up Capacity in Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA presentation: Cybersecurity for medical devices Medical Device and FDA Regulations and Standards News 0
M MDR Medical devices Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom