• Products
  • Suppliers
  • Sourcing Requests
Post Sourcing Request Exhibition
Get alerted on the PharmaSources E-Newsletter and Pharma Sources Insight E-Compilation!
Note: You can unsubscribe from the alerts at any time.
Advertising
New Products
Vibegron Intermediate CAS:1421271-01-3
Food Grade Fish Collagen
Vibegron Intermediate CAS:1295539-30-8
Vibegron Intermediate CAS:1426235-01-9
Vibegron Intermediate CAS:163625-46-5
Vibegron Intermediate

FDA Proposes Easing of Medical Device Malfunctioning Reporting

biospaceDecember 26, 2017

Tag: FDA , 4/5000 Shèbèi gùzhàng Equipment failure

The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems.

The FDA said in a statement that it is proposing to allow the manufacturers to report certain malfunctions in summary reports, rather than having to file individual reports for each malfunction. They would still be required to file individual reports for deaths and serious injuries, the agency said.

Previous:Quidel Receives FDA Clearance and CLIA Waiver for Its Point-of-Care Sofia 2 Instrument for Use with

Next:The 2017 Biotech IPO Winners and Losers

Related News

Thrombolytic Science Announces FDA’s IND Clearance of Mutant Prourokinase for the Treatment of Thrombotic Diseases

PharmaSourcesOctober 15, 2024

Thrombolytic Science, LLC (TSI), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for mutant prourokinase, a recombinant fibrinolytic pro-enzyme.

Eleva Appoints Dr. Elisabeth Lackner to its Supervisory Board Adding Broad Biopharmaceutical Industry Expertise to the Organization

PharmaSourcesOctober 15, 2024

BrainDos™ Formulated Dual GIP/GLP-1 Receptor Agonist Tirzepatide Outperforms Tirzepatide Solution (Mounjaro®) in Preclinical Study

PharmaSourcesOctober 15, 2024

FDA Proposes Easing of Medical Device Malfunctioning Reporting | Pharmasources.com

BD and ten23 health® Partner to Advance Efficiency and Quality in Aseptic Manufacturing with RFID-Enabled Prefillable Syringes

PharmaSourcesOctober 15, 2024

BD and ten23 health today announced a collaboration to develop a new way to track prefillable syringes (PFS) using RFID technology.

You may like
More>>

Hexafluorodianhydride(6-FDA)

Hexafluorodianhydride(6-FDA)
Fully compliance with FDA 21 CFR Part 11 1064nm wavelegth Handhold Raman Spectrometers

Fully compliance with FDA 21 CFR Part 11 1064nm wavelegth Handhold Raman Spectrometers
Vecuronium Bromide(FDA)

Vecuronium Bromide(FDA)
Thiophosphoramide (FDA)

Thiophosphoramide (FDA)
Deoxycyline (FDA)

Deoxycyline (FDA)
Vecuronium (FDA)

Vecuronium (FDA)
Eptifibatide acetate USFDA china manufacture 99%min

Eptifibatide acetate USFDA china manufacture 99%min
Ifosfamide (FDA)

Ifosfamide (FDA)
Compliance FDA 21 part 11 Packaging leak tester for pharmaceuticals

Compliance FDA 21 part 11 Packaging leak tester for pharmaceuticals
Daunomycin HCL( FDA)

Daunomycin HCL( FDA)

Contact Us

PharmaSources@imsinoexpo.com

Tel: (+86) 400 610 1188

WhatsApp/Telegram/Wechat: +86 13621645194

About Us
About PharmaSources
Terms of Service
Privacy Policy
Intellectual Property
Media Partners
Buy
Search Products
Post Sourcing Requests
Search Suppliers
CAS Search
Sell
Member Application
Advertising
Post Products
EZSourcing
Events
CPHI China
PMEC China
Conferences
Search Events
Help
FAQ
Contact Us
Feedback
PharmaSources Customer Service