The (FDA) is proposing to amend its postmarket medical device reporting (MDRs) regulation

August 28, 2009

The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format that FDA can process, review, and archive.

Benefit/ Advantage

  1. Mandatory electronic reporting would improve the agency’s process for collecting and analyzing postmarket medical device adverse event information.
  2. The proposed regulatory changes would provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues.

FDA is also announcing a draft guidance document that provides recommendations on how to prepare and submit electronic MDRs to FDA in a manner that satisfies the requirements of this proposed regulation.

Date to Submit:

November 19, 2009. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 (the PRA) by September 21, 2009.

Addresses to Submit:

You may submit comments, identified by Docket No. FDA–2008–N–
0393 and/or RIN number 0910–AF86, by any of the following methods

Electronic Submissions
Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments

Written Submissions

Submit written submissions in the following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA– 305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852

Instructions:

All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) (if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to http:// http://www.regulations.gov, including any personal information provided.

Source: – http://edocket.access.gpo.gov/2009/pdf/E9-19683.pdf

Also I have found some webinars which are related to MDR medical device reports which can be helpful

  1. Complaint Handling, MDR’s & Recalls
  2. Medical Device Complaints, MDR’s and Recalls
  3. Development and Audit of Complaint Handling and MDR Processes

Source:- http://www.complianceonline.com


Medical Device Webinars / trainings @$149 (On-Demand)

July 23, 2009

Are you looking for online training for Medical Device Industries and Life Sciences?  What all it has –

  • 60 minutes of online training
  • Convenient access anytime, anywhere
  • A great way to meet your educational needs
  • Courses for the Life Sciences and Medical Device Industries

Check out here –

  1. Basic Requirements for Steam Sterilizer Validation per ISO 17665
  2. Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
  3. Medical Device Complaints, MDR’s and Recalls
  4. Six Sigma Methodology for Process Validation
  5. Documenting a Risk-Based Quality System – for Compliance and Cost-Savings
  6. How to perform effective supplier audits, and avoid FDA 483’s and Warning letters
  7. Verification vs. Validation in Regulated Industries
  8. CAPA Essentials – core principles and practices needed to implement an effective and efficient CAPA process
  9. Introduction to Process Capability (Cp, CpK, Pp, Ppk)
  10. How to Use the System Risk Level to Save Time and Money on Computer System Validations
  11. Implementing the new International and FDA accepted Software Development Standard IEC 62304
  12. Risk Management Activities during Design Input
  13. Developing a Robust CAPA System
  14. Complying with 21CFR Part 11-Understanding the Role of Predicate Rules
  15. The New Dietary Supplement Good Manufacturing Practices
  16. Configuration Management and Change Control for Computer Systems
  17. Cleanroom Operation, Maintenance and Operators
  18. Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971
  19. 510(k) Preparation for a Small to Medium-Sized Company
  20. Applying Lean Documents to a Project – how to create a project file, follow design controls, yet maintain a lean set of project documents.

Quality System Inspection Technique (QSIT) :FDA

June 18, 2009

According to the FDA, 30% of the 10 most frequent observations in Form 483s issued for QSIT inspections are related to CAPA, and 50%  are CAPA-related for non-QSIT inspections.

See webinars which can help device makers to ensure quality standards

  1. CAPA – The Heart of Your Quality System
  2. CAPA systems in Post Marketing Surveillance
  3. Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm
  4. How CAPA and complaint handling should interact in Medical Device – Simplification of the processes is often needed to preserve their effectiveness
  5. Preparation of a corrective action/preventive action plan (CAPA) in Drug Safety/Pharmacovigilanc

Compliance trainings :FDA

June 4, 2009

Looking for FDA Compliance related training  then have look into following urls

All Trainings in FDA Compliance

  1. Successful FDA Pre-approval Inspections of Computer Systems
  2. The Pre-IND Process: Changes in Working with the FDA and Regulatory Procedures
  3. Auditing the QC Microbiology Laboratory for FDA Compliance
  4. What will FDA expect and request from your firm during Design Control portions of Inspections

Click here for more – ComplianceOnline


Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA’s new requirements

June 1, 2009

What you need to know in order to comply with FDA’s new requirements :Risk Evaluation and Mitigation Strategies (REMS)

FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.

Learn here –

  • What is a REMS(Risk evaluation and mitigation strategies)?
  • What products are currently required to have a REMS(Risk evaluation and mitigation strategies)?
  • Where to start when writing a REMS(Risk evaluation and mitigation strategies)?
  • What department need to be involved in the preparation of a REMS(Risk evaluation and mitigation strategies)?
  • Without a REMS(Risk evaluation and mitigation strategies) guidance document …What format is FDA currently requiiring,?

Source: ComplianceOnline


Upcoming Pharma and biotech webinars/training

May 26, 2009

Check Pharma and Biotech webinars

Compliant GCP (Good Clinical Practice) Studies – Working with a CRO

Learn here

  • Steps to meet the sponsors requirements.
  • How to know – are GCPs being followed and is it documented.
  • Know the “relationships” – QA, Clinical and the CRO.
  • The Audit (aspects and specifics).
  • How to do an audit follow-up.
  • Post CRO Assessment – How

Objectionable Microorganisms: Considering the Risk

Learn here

  • What is an Objectionable Microbe?
  • Pathogens vs. Objectionables.
  • Just how objectionable is it?
  • Consider the risk.
  • Performing a risk assessment.

Advanced Topics in Good Documentation for GXPs

Learn here

  • The documentation practices that enhance study integrity, repeatability.
  • How to prevent 483 items related to data documentation.
  • The main documentation errors seen and cited by the FDA.
  • Why GLP serves as a good foundation for clinical studies, GMP, and even research.
  • Tips for documentation in lab notebooks.

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

Learn here

  • Undertanding Japanese culture in context of JPAL.
  • Risk adversity in the MHLW, PMDA and filtering down to the MAH.
  • Language: Translations, interpretations and resulting gaps.
  • Technical differences – How to respond and persevere.
  • Culture differences – Sometimes we just have to go along.
  • Submission data – Best practices for common understanding.

Basics of testing associated with sterilization validation and routine processing

Learn here

  • What are the appropriate types of tests during sterilization validation.
  • What standards should be used for the testing.
  • What type of samples and sample sizes should be used.
  • What testing needs to be performed routinely.
  • What frequency of testing is recommended.
  • What methods can be used to reduce testing.

Source: ComplianceOnline


Compliance Questions ? get answers @ ComplianceOnline.com

May 26, 2009

co_logo_233_44Get your toughest Quality and Compliance problems solved by world renowned experts. Ask a question and get multiple answers from multiple experts and users and choose which one best solves your particular problem.

Source: ComplianceOnline


Water system compliance training/webinar

May 20, 2009

Check out upcoming list of Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.

  1. Water System Compliance – Successful Sanitization Approaches for Trouble-Free Water Quality
  2. Water System Compliance – What Makes Water Systems Have Microbial Quality Problems
  3. Water System Compliance – Harmonizing Water Microbial Testing for Optimal Quality Control
  4. Water System Compliance – Understanding and Controlling Endotoxin
  5. Water System Compliance – Implementing Changes to a Validated System

Source: ComplianceOnline


Ways to Search for a Predicate Device

May 15, 2009

The FDA 510(k) database contains all devices cleared under the 510(k) process. The FDA databases on the web are updated on or around the 5th of every month. The classification of the device and product code is essential in searching for predicate devices. Classification of your device can be found by performing a search on the Product Code Classification Database.

Information which can be useful to find a predicate device includes:

  • names of similar devices – traded name under which the device is marketed;
  • manufacturer(s) of the similar device(s);
  • marketing status, i.e., preamendments or postamendments device;
  • 510(k) numbers for postamendments devices;
  • classification information, i.e., product codes, classifying regulations, etc., for your device.

Source: FDA


Medical Device training / webinars

April 29, 2009

Check out for medical device trainings/webinars

1. Process Validation for Medical Device Manufacturers

This Process validation training will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop Process Validation Plans and conduct production Process Validation.

2. Risk Analysis and Human Factors Engineering

The Risk analysis training will incorporates these techniques into the overall product lifecycle using the principles of ISO 14971 and how to develop an integrated program incorporating risk analysis and human factors engineering.

3. Basic Requirements for Steam Sterilizer Validation per ISO 17665

This Steam Sterilization training will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134).

4. Japan – Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.

5. A Case Study in Equipment / Process Software Verification and Validation

This FDA compliance Training will guide through the models simplifies regulatory requirements for equipment software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.

6. Japanese PAL – JPAL QMS requirements in Ordinance 169 and differences to ISO 13485

This JPAL (Japanese Pharmaceutical Affairs Law) QMS will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

Source: ComplianceOnline