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Regulatory Archives

 

FDA Shows More Flair in Latest 483 Round-up (AssurXblog)

FDA Wants Standardized Terminology for Medical Devices (Medical Device CRO Blog)
FDA Requirements for Informed Consent Forms (Medmarc)

FDA to Amend Device Regulations- More or Less Burden on Sponsors? (Medical Device CRO Blog)

FDA Forms Public-Private Partnership To Advance Regulatory Science (Aptiv Solutions)

Draft Guidance for Industry and Food and Drug Administration Staff – Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex (FDA.gov)

Funding Cutbacks at FDA: A Sequester Primer (FDA Matters)

Empowering the Regulatory Affairs Professional: High Edge Consulting Launches Six New Training Courses in 2013 (Medical Device Network)

Types of Communication During the Review of Medical Device Submissions – Draft Guidance for Industry and Food and Drug Administration Staff 

Sequestration Takes Hold: Full FDA Impact Remains To Be Seen (Medical Devices Today)

Industry Applauds FDA Moves to Speed 510(K) Review Process (AssurX blog) 2/29/2013

MEDEC analysis: Increased review times at Health Canada (MassDevice) 2/20/2013

Industry and EU clash over medical devices regulation (MedCity News) 2/20/2013

Big changes to medical device regulations in Russia (ForeignExchange Translations) 2/7/2013

New Malaysian medical device market regulations published (MassDevice) 2/1/2013

FDA’s Fourth Annual Report to Congress on 505(q) Citizen Petitions; Agency Continues to Express Concerns About the Use and Effects of 505(q) (FDA Law Blod) 1/21/2013

Guidance MEDDEVs(European Commission – 1/28/2013)

FDA’s New RTA Policy Is Just What Some Companies Need(Pilgrim Software – 1/25/2013)

FDA Issues Final Rule on CGMP Requirements for Combination Products; Requirements for “Convenience Kits” Defined(FDA Law Blog – 1/24/2013)

FDA abandons off-label marketing protection ruling(MassDevice – 1/24/2013)

Primer on U.S. FDA’s new 510(k) refuse to accept policy(MassDevice – 1/23/2013) 

New EU Electronic Labeling Rules for Medical Devices Coming in March 2013 (MassDevice – January 17, 2013)

This FDA Medical Device Enforcement Report is Going to Surprise You. A Lot. (MedCity News – January 17, 2013)

FDA to Medical Device Submitters Using WebTrader: Remove Your Files Now (AssurX Blog – January 17, 2013)

FDA hopes to improve efficiency of clinical trials(Pearl IRB -1/15/2013)

 FDA partners with Medical Device Innovation Consortium(Pearl Pathways – 1/15/2013)

FDA Ramps Up Focus on Advertising of Restricted Devices to Consumers (FDA Law Blog – January 7, 2013)

CDRH Releases Three Final Guidance Documents(FDA Law Blog – 1/3/2013)

Medical Devices Regulations(SOR/908-282)(Justice Laws Website – 12/10/2012)

CDRH 2013 Strategic Priorities (FDA CDRH)

FDA Details Changes to Medical Device Review Groups (MassDevice – December 20, 2012)

Australia, Brazil, Canada, and U.S. Plan Shared Medical Device Audit Program (MassDevice – December 20, 2012)

FDA Releases Draft Guidance on Enrichment Strategies for Clinical Trials (FDA Law Blog – December 18, 2012)

New Medical Device Regulations Proposal: What Are the Implications for Safety Reporting? (DTarget – December 2012)

Regulatory Changes Ahead for EU In Vitro Diagnostics (IVD, Regulation 0267) (DTarget – December 2012)

Medtech Regulatory Update: Top Regulations and Standards to Prepare for in 2013 (Medtech Insider – December 13, 2012)

CDRH Issues Report on Improvements in Device Review (FDA Law Blog – December 3, 2012)

CDRH Fiscal Year 2012 (FY 2013) Proposed Guidance Development (FDA CDRH)

Indian Regulators Issue New Registration, Licensing Guidance for Medical Devices (MassDevice – November 28, 2012)

Pakistan to Establish Regulatory System for Medical Devices (MassDevice – November 23, 2012)

FDA Seeks Comments on Custom Devices (FDA Law Blog – November 20, 2012)

FDA Unveils Reorganized Device Review Unit (MassDevice – November 9, 2012)

Major Changes to Russian Medical Device Regulations Planned for 2013 (MassDevice – November 8, 2012)

Device TRade Group Asks FDA to Clarify and Change Proposed Rule on Unique Device Identifiers (MedCity News – November 8, 2012)

CDRH Reorganizes its Office of Device Evaluation (FDA Law Blog – November 7, 2012)

Regulatory Update: New FDA Requirements for Contract Manufacturers (MPO Magazine – November 4, 2012)

New 510(k) Timeframe and Performance Goals at U.S. FDA (MassDevice – October 29, 2012)

FDA Compliance Officer: Industry, FDA Must Focus on Device Quality (Not Just Compliance) (MedCity News – October 23, 2012)

IRB . . . As Easy As 123! (MedCity News – October 18, 2012)

Pre-Review Guidance Aims to Accelerate Medical Device Approval Process (Aptiv Solutions – October 17, 2012)

FDA’s Voluntary ISO Audit Submission Program (FDA Law Blog – September 30, 2012)

Euro Device Makers Cry ‘Nay’ on FDA-Like Proposal for Medtech Review (MassDevice.com – September 26, 2012)

Europe’s More Stringent Medtech Review May Bring Costly Delays (MassDevice.com – September 19, 2012)

FDA Details New Medical Device Registration and Listing Requirements (MassDevice.com – September 17, 2012)

New Draft EU Regulations May Be Speculation Now . . . (QC Is Dead – September 14, 2012)

FDA FAQ on Medical Device Registration and Listing Changes (Emergo Group – September 12, 2012)

National Medical Device Postmarket Surveillance Plan (FDA CDRH)

What’s the Difference Between a Regulatory Strategy and a Regulatory Plan? (MD&DI – September 7, 2012)

FDA Outlines Postmarket Surveillance Plan Ahead of Public Meetings (MassDevice.com – September 7, 2012)

Top 6 Tips for Avoiding 510(k) Submission Processing Delays (Aptiv Solutions – September 6, 2012)

The New EU Regulations – 21 Days and Counting! (QC is Dead – September 5, 2012)

FDA Chief Hamburg Sees Improvement in Medtech Review (MassDevice.com – August 27, 2012)

FDA Gears Up for GDUFA Implementation and ANDAgeddon (FDA Law Blog – August 23, 2012)

Summer Clearance: More FDA ‘Spygate,’ CAPA Warnings (AssurX Blog – August 23, 2012)

When Do Product Changes Require A New 510(k) Submission? (Aptiv Solution – August 21, 2012)

Balancing Regulatory Compliance with Key Business Goals (Business Intelligence Solutions – August 15, 2012)

Medical Device Regulatory Process Scrutinized (The Mullings Group)

New FDA Warning Letters Show Old Focus on CAPA Remains (AssurX Blog – August 13, 2012)

FDA Issues New Refuse to Accept Policy for 510(k)s (FDA Law Blog – August 13, 2012)

FDA Proposes New 510(k) Pre-Review to Cut Out Incomplete Applications (MassDevice – August 10, 2012)

Contract Manufacturers and Contract Sterilizers Must Now Register and List Under New FDA Regulations (FDA Law Blog – August 8, 2012)

China Regulatory Officials Now Can Perform Unannounced Inspections on Device Manufacturers (MPO Magazine – August 7, 2012)

Eucomed, EDMA Applaud EU-Japan Free Trade Initiative (MedTech Insider – August 1, 2012)

WEEE2 Will Impose Recovery and Recycling Requirements on Medical Devices (MassDevice – August 1, 2012)

FDA Divides Filing Criteria for PMAs into “Acceptance Criteria’ and “Filing Criteria” (FDA Law Blow – July 31, 2012)

FDA Releases Medical Device User Fees for 2012 (MassDevice – July 31, 2012)

FDA Issues Draft Guidance Expanding Pre-IDE to Pre-Submission Program (FDA Law Blog – July 22, 2012)

FDA Formalizes PMA Requirement For All Implantable Pacemakers, Programmers (MassDevice – June 22, 2012)

Congress Leaves FDA to Complete Job on Mobile Health Apps Regulation (iMedicalApps – June 21, 2012)

FDA to Officially Lower Risk Level for Implanted Blood Access Devices (MassDevice – June 20, 2012)

House Authorizes Doubled FDA User Fees for Medical Devices (MassDevice – June 20, 2012)

Compliance Takes Back Seat to Quality at CDRH (MDDI – June 20, 2012)

FDA-CDRH Director Jeff Shuren Touts Improvements in the FDA Process (OrthoStreams – June 16, 2012)

New FDA Guidance: Transferring IRB Oversight in Clinical Trials (Medical Device CRO Blog – June 15, 2012)

Small Companies Suffer Most from FDA’s 510(k) Process, Survey Finds (medtechinsider – June 12, 2012)

FDA Should Be Required to Provide 510(k) Decision Summaries (FDA Law Blog – June 12, 2012)

Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Federal Register – June 12, 2012)

OIG Releases Report Regarding Scientific Disagreements at CDRH (FDA Law Blog – June 5, 2012)

Do Devices Need More Risk Analysis? (Medical Device CRO Blog – May 29, 2012)

The Quality System Habit (Business Intelligence Solutions – May 7, 2012)

FDA Issues Final Rule on Sterility Testing of Biological Products (FDA – May 3, 2012)

The Anatomy of a Warning Letter (BoneZone – March 12, 2012)