• 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
PVP-K30-----pharma excipients(CAS No.9003-39-8)
Tobramycin
Povidone iodine 20% powder
Povidone iodine 10% powder
SULBACTAM SODIUM STERILE
Food Additives Bulk Sucralose Neotame Advantame Powder

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

InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 for Acute Myeloid Leukemia in China

PharmaSourcesSeptember 19, 2024

InnoCare Pharma announced today the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia (AML) in China.

Cordlife Unveils Enhanced Processing and Storage Facility in Singapore; Strengthens Processes as It Resumes Collection of Cord Blood Units in a Controlled Manner

PharmaSourcesSeptember 18, 2024

Latest Data of InnoCare’s Orelabrutinib Presented at the European Society for Medical Oncology (ESMO) Congress 2024

PharmaSourcesSeptember 14, 2024

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

Currax Pharmaceuticals: CONTRAVE®/MYSIMBA® Demonstrates Positive Cardiovascular Safety in a Large, Real-World Evidence Study

Biotech NewswireAugust 28, 2024

Currax Pharmaceuticals LLC announced the results of a Cardiovascular Health Outcomes Analysis.The results showed there is no evidence of excess cardiovascular risk.

You may like
More>>

filter integrity testing fda guidelines

filter integrity testing fda guidelines
Fully compliant FDA 21 CFR part 11 handheld raman spectrometer

Fully compliant FDA 21 CFR part 11 handheld raman spectrometer
Fluorfenicol( FDA)

Fluorfenicol( FDA)
Praziquantel (FDA)

Praziquantel (FDA)
Tobramycin base( FDA)

Tobramycin base( FDA)
Simvastatin (FDA)

Simvastatin (FDA)
Cilostazol(FDA Approved) (Micronized)

Cilostazol(FDA Approved) (Micronized)
Bumetanide (FDA)

Bumetanide (FDA)
Medroxyprogesterone Acetate(FDA)

Medroxyprogesterone Acetate(FDA)
Clindamycin Phosphate( FDA)

Clindamycin Phosphate( 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