Simplifying Global Compliance
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September 2018
No. 464
Headlines
Full Issue of The GMP Letter in PDF Format
Download and view the full issue. Read More
DITTA Urges FDA to Fix MDSAP Inconsistencies
The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association is calling on the FDA and the Medical Device Single Audit Program consortium to review the program’s inconsistencies and revise companion documents so devicemakers and auditing organizations are clear on expectations. Read More
FDA to Allow Combo Products to Submit Malfunction Summary Reports
The FDA is allowing manufacturers of combination products to submit certain device malfunction medical device reports on a quarterly basis. Read More
FDA Proposes Certain Device Accessories Be Defined As Class I
The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed list. Read More
FDA Pushes Back UDI Compliance Date for Combination Products
The FDA extended the compliance date for Global Unique Identification Database (GUDID) submission requirements for combination products, giving devicemakers another year to comply. Read More
TGA Offers New Guidance on Electronic Instructions for Use
Australia’s Therapeutic Goods Administration issued new guidelines on electronic instructions for use for medical devices. Read More
Health Canada Updates Requirements for Class II/III Infusion Pumps
Citing post-market safety concerns about the delivery accuracy of infusion pumps, Health Canada is updating the evidence requirements to demonstrate the accuracy of these devices through performance testing for new and amended license applications. Read More
Sponsors Find Benefits, Barriers in Using Real-World Evidence
As the FDA expands its use of real-world evidence, medical device companies are starting to explore the benefits — and the challenges. Read More
483 Roundup: FDA Flags Seven Firms for GMPs
The FDA hit seven devicemakers for a range of GMP and other violations observed during agency inspections. Read More
FDA Warns Zimmer Biomet for Quality Violations
Zimmer Biomet’s Warsaw, Indiana orthopedic implant manufacturing facility drew a warning from the FDA for quality violations dating back to 2016 after an April inspection revealed ongoing problems. Read More
Health Canada Plans 3D Printing Guidance
Health Canada is developing guidance to help devicemakers seeking to license 3D-printed medical devices. Read More