New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them

The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating to food transportation. This is something required by the Food Safety Modernization Act (FSMA), under congressional instructions.

Many aspects of food transportation come under the ambit of these new FSMA Rules. These include:

–       Foods not completely enclosed by a container

–       Prevention and reduction in adulteration and risk

–       Personnel training and certification for this purpose

–       Inspecting food and collecting data

–       Maintaining compliance and reporting about its evidence.

How to do this right?

Comprehension of all the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods is necessary and important for organizations that work in food transportation. They also need to know how to implement these rules. It is this understanding that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer at a seminar it is organizing.

The Director of this two-day seminar is John Ryan, President, TransCert, QualityInFoodSafety, RyanSystems. To gain insights into how to understand all the aspects of the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and to understand how to comply with them, just register for this session by visiting . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

At this seminar, the Director will arm participants with an understanding of the legal requirements of food transportation and how to develop a company plan that meets the expectations and requirements of both its customers and the FDA. Also offered is total understanding and review of the ways of establishing the right temperature monitoring, sanitation, container test and traceability, training and data reporting procedures.

Technological aspects of FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Technological aspects of food transportation are gaining importance. These include new low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing. FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods have a close relationship with these. The Director of this seminar will take these up for examination.

In reviewing the future of transportation food safety in the light of new and evolving technologies; the Director will dot the seminar with references to upcoming technology providers and provide Internet links to detailed information on the same.

This seminar is immensely useful for food supply chain logistics and food safety and security personnel whose primary responsibilities include management, sanitation, quality and operations. Those involved with handling incoming and outgoing food shipments, maintaining transportation equipment and tools, and purchasing or selling will also derive high value out of this seminar.

Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

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DME’s help improve the quality of the patient’s life at home

Description: The patient must be incapable of performing routine activities without the DME

 What is a DurableMedical Equipment?


Any medical equipment used in the home in order to help in a better quality of living can be called as durable medical equipment (DME). This includes iron lungs, oxygen tents,power scooters, Nebulizers, catheters, hospital beds, wheelchairs, walkers, and portable oxygen equipment.

Characteristic Features of a Durable Medical Equipment

An equipment is called as a DME, if

  • It is primarily used  for medical purposes and is meant to be used for medical purposes
  • If it can be subject to repeated use
  • In the absence of a medical condition, this equipment is of no use to the person
  • It is designed to be used in and around the home


Certain insurances cover prosthetics, orthotics and certain other supplies, which are collectively denoted as POS, under durable medical equipment. These are devices that can replace missing body part, and support or correct any bodily malfunction.

Equipmentthat are Not Durable Medical Type

  • Items that are use-and-throw are not durable medical equipment; some examples are surgical face masks, incontinence pads and leggings.
  • Items that are not appropriate to be used at home, such as paraffin bath units and oscillating beds.
  • Items that need to be used under medical supervision or under medical institutional settings
  • Items that are not intended to be used in the home but are primarily used outside the home.
  • Items used for convenience rather than medical need.  Some examples are stairway elevators, bathtub and toilet seats.

Qualifying for a DME

Any person can purchase durable medical equipment on a prescription from his treating physician. For one to qualify for a DME reimbursed by his or her insurance the following criteria need to be met:

  1. The equipment must be a medical need for a normal living.
  2. It must meet the definition of durable medical equipment.
  3. The physician must justify that the DME is a requirement to safety and effectively treat the patient.
  4. The patient must be incapable of performing routine activities without the DME
  5. The physician must prove that the absence of the DME significantly hampers the patient’s normal living.
  6. The patient must be able to operate, or use the equipment without any assistance.
  7. The equipment must be safe enough to be used in a home environment.


Some insurance companies cover certain disposable items as a part of durable medical equipment reimbursement if they can significantly lower the risks associated with the medical condition and or if they are important preventive care measures. Some examples are nondurable items such as lancets and test strips used for glucose testing in diabetics.

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