Boyce Consulting

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HOT TOPICS

We will keep you updated on some of the "hot topics" and changes that are occurring. Please visit us for continuing updates and news!

MEDICAL DEVICES:

GENERAL:

CDRH has published its strategic priorities for 2011. In Summary, this includes the following:

Fully implementing a total product life cycle Approach.
Enhancing Communication and Transparency.
Strengthening the Workforce and Workplace.
Proactively Facilitating Innovation and Addressing Unmet Public Health Needs.

FDA NEW GUIDANCE AND POLICY INFORMATION:

FDA Commissioner Margaret A. Hamburg M.D. launched FDA’s Transparency Initiative in June 2009 in response to the Obama administration’s commitment to openness in government. After holding public meetings and inviting written comments, FDA issued a report proposing 21 actions to increase disclosures about agency activities. The actions announced today stem directly from that effort and are among the first of the proposals to be implemented.

For more information:
Summary of the most common inspectional observations of objectionable conditions or practices that are made during inspections. http://www.fda.gov/iceci/EnforcementActions/ucm250720.htm

Searchable database that includes the name and address of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification. http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm

FDA’s Transparency Initiative
http://www.fda.gov/AboutFDA/Transparency/default.htm

Inspectional Database:
http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm

MEDICAL DEVICES (domestic activities):

FDA is tightening its compliance reigns. More stringent inspection of your company’s supplier controls are being implemented. Ensure your supplier qualification procedures and approved supplier lists are in compliance, monitored and controlled.

One company just received a Warning Letter from FDA stating the company had not performed on-site audits of their critical suppliers. Another company received a Warning Letter since there was no supplier qualification documentation.

FDA is also still emphasizing management controls. Another company just received a FDA-483 stating there was no evidence of management review meetings being held.

FDA is planning to improve the 510(k) review path for medical devices.

The U.S. Food and Drug Administration has delineated a plan containing 25 actions it intends to implement during 2011 to improve the 510(k) path to market for medical devices.

Key actions include:

Streamlining the “de novo” review process for certain innovative, lower-risk medical devices,
Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process,
Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.

QSIT:

FDA's current auditing program is called QSIT (Quality System Inspection Technique) and addresses four major quality subsystems including Management Controls, Design Controls, Production and Process Controls (P&PC), and Corrective and Preventive Actions (CAPA) ARE YOU PREPARED FOR FDA'S INSPECTIONAL STRATEGIES? Contact Boyce Consulting for additional information.

FDA’s current policy is that you only have 15 days to respond to a Form FDA-483, list of problems discovered by FDA or a Warning Letter. So it is best not to obtain an FDA-483 or Warning Letter, contact us for help.