Current News
Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices -- January 2009
http://www.fda.gov/oc/op/goodreprint.html
Medical Devices; Medical Device Reporting; Baseline Reports -- Effective October 27, 2008
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-13350.htm
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
The Guidance can be downloaded at http://www.fda.gov/cdrh/ode/guidance/1668.html
GHTF publishes "Summary Technical Documentation for Demonstrating Conformity"
A new SG1 document has been posted recently as a final document. The document can be downloaded at http://www.ghtf.org/sg1/sg1-final.html.
Singapore's Health Sciences Authority (HSA) Implements Health Products Act 2007
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/regulatory_updates.html
FDA / CDRH Posts Important New Guidance Documents
Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Application Manufacturing Information and Operation http://www.fda.gov/cdrh/comp/guidance/1566.pdf
Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements http://www.fda.gov/cdrh/ode/guidance/1655.pdf
Group Studies EcoDesign
EcoDesign is a new concept aimed at reducing energy consumption of products. Medical devices will be included in a future directive. Follow the group's progress at http://www.epta.gr/xar/index.php/eco
Global Harmonization Task Force (GHTF) Drafts available
The following draft documents remain available.
SG1(WD)/N045R12 Principles of IVD Medical Devices Classification
SG1(WD)/No46R3 Premarket Conformity Assessment for In Vitro Diagnostic Devices
Guidelines on Issuing Instructions for Use (IFU) in Non-Paper Format are Released
A recently published MEDDEV document, 2.14/3 rev.1 provides guidelines on issuing IFU to professional users of in vitro diagnostic products in a format other than paper. While the guideline is not legally binding, it was drafted by various parties including Compentent Authorities. The guidelines can be downloaded from the following address:
http://ec.europa.eu/enterprise/medical_devices/meddev/2_14_3_rev1_ifu_final.pdf
Please note that these guidelines only apply to in vitro diagnostic products. The Medical Device directive still requires IFU in the form of printed sheets accompanying the devices.
Important FDA Guidance
Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; http://www.fda.gov/cdrh/oivd/guidance/1171.pdf
Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program http://www.fda.gov/cdrh/comp/guidance/1602.pdf
Electronic Medical Device Reporting (eMDR) http://www.fda.gov/cdrh/emdr/
Public Health Service Act Certification to Accompany Submissions: http://www.fda.gov/cdrh/news/121307.html
New Guidance on Electronic Submissions: http://www.fda.gov/cdrh/elecsub.html
New Standards Form (Form 3654): http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3654.pdf (Note: As of 1/2/08, this form must be submitted with any Premarket Notification that uses a standard)
Electronic Copies for Pre-Market Submissions - General Information / Q&A: http://www.fda.gov/cdrh/elecsub.html
FDA Issues Guidance for Industry and FDA Staff -- Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions http://www.fda.gov/cdrh/oivd/guidance/1590.html
Annual Reports for Approved Premarket Approval Applications (PMA): www.fda.gov/cdrh/ode/guidance/1585.pdf (You'll need to cut and paste this link into your browser)
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays: http://www.fda.gov/cdrh/oivd/guidance/1610.pdf
Report issued by the Postmarket Transformation Leadership Team: www.fda.gov/cdrh/postmarket/mdpi-report-1106.html
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests: http://www.fda.gov/cdrh/osb/guidance/1620.html
Guidance for Industry and FDA Staff - Frequently Asked Questions on Recognition of Consensus Standards: http://www.fda.gov/cdrh/osel/guidance/109.html
Draft Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions: http://www.fda.gov/cdrh/oivd/guidance/1587.html
Last Updated January 26, 2009
