Thegmpletter

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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