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Association of Indian Medical Device Industry (AIMED)
Abstracts Of Regulatory Report – July 2011
IVD Medical Devices
A new regulatory framework commenced operation on 1 July
2011. An overview of the framework can be viewed within a TGA document to be
found in the Medical Devices section of the TGA website
Low Value turnover
Therapeutic Goods that qualify for “low value” turnover may
be exempt from annual listing charges Details can be sourced from the TGA
website
Therapeutic Goods orders (TGOs)
Apart from compliance with international and other standards,
particular Australian requirements for therapeutic goods are contained within a
series of Therapeutic Goods Orders (TGOs). Current TGOs are available from the
TGA website.
THE RECAST OF THE MEDICAL DEVICE DIRECTIVES
It looks definite now that Directives 93/42/EEC and
90/385/EEC merged into one “regulation”. The impact assessment will be finalized
in August 2011 and then presented to the European Impact Assessment Board in
September 2011. The final, formal legislative text will be published in the
first half of 2012, without second consultation of stakeholders. When we know
more we will circulate details.
US FOOD AND DRUG ADMINISTRATION NEWS
GENERAL ANNOUNCEMENTS
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Federal Register:
Cardiovascular Devices; Classification of Electrocardiograph Electrodes
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Federal Register:
Standard Operating Procedure for Notice to Industry Letters
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Federal Register:
Medical Devices; General and Plastic Surgery Devices; Classification of the
Focused Ultrasound Stimulator System for Aesthetic Use
Analysis of Premarket Review Times Under the 510(k) Program -
The chart prepared by FDA shows the average review time had increased from 90
days in 2005 to 140 days in 2011 with some 2010 submissions still under review.
FDA blames industry due to delays in responding Additional Information (AI)
requests, however further investigation of AI by FDA within the report reveals
the following:
“FDA further analyzed the AI Letters to determine how often
the questions that were asked were appropriate or inappropriate, i.e. were the
AI Letters justified or did the reviewer ask for information or data that were
not permissible as a matter of federal law or FDA policy, or unnecessary to make
an SE determination. Results from Cohort 1 showed that reviewers asked for data
that had not previously been requested for particular device types 12% of the
time. Of those requests, 4% were appropriate,
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Information on Mobile
Medical Applications
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PMA Final Decisions
for May 2011
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Letter to Foreign and
Domestic Medical Device and Component Establishments That May Be Affected by the
March 2011 Japan Earthquake and Tsunami
SAFETY NOTICES
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FDA Safety
Communication: UPDATE on Serious Complications Associated with Transvaginal
Placement of Surgical Mesh for Pelvic Organ Prolapse
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Information on
Urogynecologic Surgical Mesh Implants
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Video - FDA Advises
Health Care Providers about Breast Implants and ALCL
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Video - FDA Advises
Women with Breast Implants about ALCL
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Booklet - Breast
Implants: Local Complications and Adverse Outcomes (PDF)
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Information on Breast
Implants Update on the Safety of Silicone Gel-Filled Breast Implants - Executive
Summary
RECENT GUIDANCE DOCUMENTS
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Guidance for Industry
and FDA Staff - Class II Special Controls Guidance Document: Focused Ultrasound
Stimulator System for Aesthetic Use
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Guidance for Industry
and FDA Staff - Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection or Detection and Differentiation of
Influenza Viruses
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Draft Guidance for
Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic
Devices
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Draft Guidance for
Industry and Food and Drug Administration Staff - Enforcement Policy for
Premarket Notification Requirements for Certain In Vitro Diagnostic and
Radiology Devices
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Draft Guidance for
Industry and Food and Drug Administration Staff - Applying Human Factors and
Usability Engineering to Optimize Medical Device Design
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