As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2011年 7月 20日

New FDA Study: Insufficient 510(k) Submissions Causing Bulk of 510(k) Review Delays

A new analysis of 510(k) premarket review timeframes by the US Food and Drug Administration cites response times from companies to additional information requests as the key causes of review delays. Overall, the FDA study found that between 2001 and 2010, percentages of 510(k) submissions that prompted Additional Information (AI) requests increased steadily and substantially—from 38% in 2001 to 77% in 2010. Average 510(k) decision time frames during that same period followed a similar trajectory, particularly from 2005 onward: In 2001, 510(k) decisions took an average of 102 days to reach, and in 2010 that average increased to 140 days. (These numbers track closely to a recent analysis of 510(k) clearance timeframes conducted by Emergo.)
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2011年 7月 22日

Draft Rules on Electronic Instructions for Use Published by EU

The European Commission has published draft regulation covering electronic instructions for use in the European Union that would affect both device medical device manufacturers and notified bodies.
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2011年 7月 22日

India's Medical Device Approvals Stalled

Drugs Control General of India (DCG(I)), the country’s regulatory agency overseeing medical devices and pharmaceuticals, is currently lacking a director, stalling all
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2011年 7月 25日

New Guidance from Health Canada on Medical Device License Renewal

Health Canada has published new guidance for manufacturers of Class II, III and IV medical dev
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2011年 7月 26日

FDA Clarifies When Device Modifications Require New 510(k)s

New 510(k) submissions. The new guidance, 510(k) Device Modifications: Deciding When to Submit a 510(k)...
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2011年 7月 26日

Brazil relaxes BGMP requirements for manufacturers holding INMETRO certification

New regulations were recently enacted by Brazil's National Health Surveillance Agency (ANVISA).
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2011年 7月 29日

IOM Report: Scrap 510(k) Process

A highly anticipated report by the Institute of Medicine of the National Academies (IOM) has...
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2011年 8月 1日

Brasilien vereinfacht BGMP-Anforderungen für Hersteller mit INMETRO-Sicherheitszertifikat

Mit diesem Mitteilungsblattinformieren wir Sie über neue Vorschriften, die vor kurzem von der brasilianischen Regulierungsbehörde zur Gesundsheitsüberwachung (ANVISA) erlassen wurden.
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2011年 8月 1日

IOM Report: FDA 510(k) Program Too Flawed to Salvage

A long-awaited report issued July 27 by the Institute of Medicine of the National Academies (IOM) has recommended that the US Food and Drug Administration (FDA) replace its current 510(k) program for Class II medical device reviews with a new process that does not rely on substantial equivalence for clearance decisions.
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2011年 8月 1日

Le Brésil assouplit les exigences relatives aux Bonnes Pratiques de Fabrication Brésiliennes (BGMP) pour les fabricants en possession de la certification INMETRO

Par la présente, nous vous informons des nouvelles dispositions récemment adoptées par l’Agence nationale de surveillance sanitaire au Brésil (ANVISA).
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