Radiofrequency Identification (RFID)

January 25, 2010

Radio Frequency Identification (RFID) is a tool for identifying and tracking items or people.

In an RFID system, a small memory-storage chip (tag) is placed on an item. RFID readers (emitters) send out radio waves to detect tags and read their data.

Uses

RFID systems are used in many places. Some examples include:

  • Stores, warehouses and shipping areas for inventory control
  • Pharmacies or pharmaceutical distributors for pharmaceutical supply management
  • Worksites for employee identification
  • Transportation systems for fare collection (i.e. subway passes) and highway toll collection (i.e. EZ Pass)

Risks/Benefits

RFID technology has many applications for health care. For example, RFID can potentially improve patient safety by:

  • Ensuring that patients receive the correct medications and medical devices
  • Preventing the distribution of counterfeit drugs and medical devices
  • Facilitating device recalls

Source: http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htm


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

Tight Regulation Over Cigarettes: Got Approved

June 15, 2009

More than four decades after the surgeon general declared smoking a health hazard, the Senate on Thursday cleared the final hurdle to empowering federal officials to regulate cigarettes and other forms of tobacco for the first time.

The Congressional Budget Office has estimated the new law would reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade, in addition to reductions already achieved through other actions, like higher taxes and smoke-free indoor space laws.

Law gives power to FDA:

  • Law would give the F.D.A. power to set standards that could reduce nicotine content and regulate chemicals in cigarette smoke.
  • The law also bans most tobacco flavorings, which are considered a lure to first-time smokers.
  • The law would also tighten restrictions on the marketing and advertising of tobacco products.
  • Colorful ads and store displays will be replaced by black-and-white-only text.

Beginning next year, all outdoor advertising of tobacco within 1,000 feet of schools and playgrounds would be illegal.

What Cigarette Makers required to do:-

Cigarette makers will be required to stop using terms like “light” and “low tar” by next year and to place large, graphic health warnings on their packages by 2012.

Source: The New York Times


FDA revises ICH Q8 guidance

June 11, 2009

The FDA has revised its guidance on ICH Q8, adding an annex that clarifies the original document and adds the principles of quality by design (QbD).

The US Food and Drug Administration’s (FDA) guidance states that different drug delivery methods will have varying CQAs, such as adhesion properties for transdermal patches, but raw materials such as excipients and intermediates are common factors.

Using the framework devised by the International Conference on Harmonisation (ICH) the guidance details the importance of identifying CQAs and using knowledge of them to guide product and process development.

Source: in-pharmatechnologist


FDA Warning Letters to Pharmaceutical Companies in 2009

May 28, 2009

fda_mast_01Warning Letters and Untitled Letters to Pharmaceutical Companies in 2009 here you will get the following information-


  1. Product/Issue
  2. Company/Individual
  3. Division/Office
  4. Released Date
  5. Posted Date

http://www.fda.gov/cder/warn/warn2009.htm


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


About Predicate Device (Medical Device)

May 15, 2009

A Premarket Notification [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA). Submitters must compare their 510(k) device to a similar legally marketed U.S. device(s). A device recently cleared under 510(k) is usually used as a predicate device.

The legally marketed device(s) to which equivalence is drawn is known as the predicate device(s).

A claim of substantial equivalence does not mean the device(s) must be identical.Substantial equivalence is established with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. You can claim SE to either a preamendments or postamendments device that is or was legally marketed. Legally marketed means that the predicate cannot be one that is or was in violation of the Federal Food Drug & Cosmetic (FD&C) Act. An applicant may claim SE to a device that is no longer being marketed in the U.S.

Source: FDA