FDA/CDRH Industryಪರಿಶೀಲಿಸಿದ ಖಾತೆ

Webinar 2/9/17: Factors 2 Consider - Benefit-Risk in Med Dev Product Availability, Compliance, & Enforce Decisions http://go.usa.gov/x9Mcg 

Webinar - Final Guidance on Medical Device Accessories 2/2/17; 1 pm ET http://go.usa.gov/x9HTu 

#FDA coauthored article on Registry-Based Prospective, Active Surveillance of Medical-Device Safety http://ow.ly/pFV3308zcrq  #medicaldevice

Webinar Presentation & Transcript - Postmarket Management of Cybersecurity in Medical Devices - 1/12/17 http://go.usa.gov/x9fSG 

Submission for OMB Review; Comment Request; Premarket Approval of Medical Devices http://go.usa.gov/x9f5S  #fda #medicaldevice

Medical Product Communications That Are Consistent With FDA-Required Labeling--Draft Guidance http://go.usa.gov/x9y6b 

Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Med Products; Reopen Comment Period http://go.usa.gov/x9y62 

Drug & Device Manufacturer Communications With Payors, Formulary Committees, & Similar Entities--Draft Guidance http://go.usa.gov/x9y6a 

Adverse Event Program for Medical Devices (Medical Product Safety Network) http://go.usa.gov/x9yHt  #fda #medicaldevice

Medical Product Communications that are Consistent with the FDA-required Labeling - Qs & As http://go.usa.gov/x9ycn 

Drug & Device Manufacturer Communications with Payors, Formulary Committees, & Similar Entities - Qs & As http://go.usa.gov/x9ycX 

Webinar 2/23/17 - Factors 2 Consider When Making Benefit-Risk Determinations 4 Med Dev IDEs http://go.usa.gov/x9Psg  #medicaldevice

Reclassification of Influenza Virus Antigen Detection Test Systems Intended 4 Use Directly W/ Clinical Specimens http://go.usa.gov/x9PKg 

Joint Meeting of the Ophthalmic Devices Committee & the Risk Communication Advisory Committee 3/17/17 http://go.usa.gov/x9PKx  #fda

Factors 2 Consider When Making Benefit-Risk Determinations 4 Medical Device IDEs - Guidance http://go.usa.gov/x9PBe  #fda #medicaldevice

Confirmed cybersecurity vulnerabilities in St. Jude’s implantable cardiac devices & Merlin@home Transmitters http://go.usa.gov/x9nvP 

Meeting Notice: 2/23/17 Circulatory System Devices Committee http://go.usa.gov/x9nn5  #fda #medicaldevice

Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh http://go.usa.gov/x9WhS  #fda #medicaldevice

#FDA Reclassifies Surgical Instrumentation 4 use w/ Urogyn Surgical Mesh from Class I to Class II http://go.usa.gov/x92Hm  #medicaldevice