FDA Updates Guidance on 510(k)s for Expandable Biliary Stents
The FDA released new draft guidance for devicemakers on submitting premarket notifications for metal expandable biliary stents and their delivery systems. Source: The GMP Letter
483 Roundup: FDA Cites Six Device Firms for GMP Issues
The FDA hit six U.S. devicemakers with 483s for problems agency investigators observed in facility inspections including inadequate risk procedures, labeling and complaint handling. Source: The GMP Letter
IMDRF Opens Consultations on AERs, Principles for Labeling and UDIs
IMDRF’s Adverse Event Terminology Working Group is seeking comments on proposals to harmonize terminology globally for reporting adverse events for medical devices and in vitro diagnostics. Source: The GMP Letter
FDA Cautions Bayer Over Postmarket Requirements for Essure
Bayer announced it would stop selling its Essure permanent birth control device after Dec. 31 and the FDA said it expects the company to meet its postmarket obligations. Source: The…
Brazil Introduces Firsts Unique Device Identifier Requirements
Brazil released its first requirements for unique device identifiers for high-risk medical devices that are slated to go into effect in 2020. Source: The GMP Letter
Stakeholders Respond to Congress on Medical Device Cybersecurity
In response to a request for information on medical device cybersecurity by the House Energy and Commerce Committee, stakeholders called for additional guidance and funding to help resolve cybersecurity flaws.…
Civil Liberties Group Urges FDA to Stop Issuing ‘Improper’ Guidance
The New Civil Liberties Alliance (NCLA) filed a petition asking the FDA to stop using ‘improper” agency guidance to impose obligations on drugmakers and instead issue clear rules and notice-and-comment…
N.J. Supreme Court Throws Out Plaintiffs’ Expert Testimony in Accutane MDL
Multi-district litigation over Roche’s anti-acne drug Accutane (Isotretinoin) hit a wall this week when the New Jersey Supreme Court ruled against allowing certain expert testimony. Source: Drug Industry Daily
EMA to Further Scale Back Activities As Brexit Creates Staff Upheaval
The European Medicines Agency said Wednesday it needs to scale back or suspend more activities, blaming Brexit for staff reductions that are disrupting its ability to function. Source: Drug Industry…
FDA Cites Akorn for Contamination Protections, Aseptic Processing
The FDA hit Akorn with a lengthy Form 483 with 13 observations for failing to properly safeguard against microbiological contamination and to monitor conditions in aseptic processing areas following April/May…
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