Regulatory Affairs Syndicator

Advertising and promotion of medical devices.

J Health Law. 2006;39(2):265-82

Authors: Portnoy S

Dr. Portnoy, a former senior clinical reviewer and manager for the FDA’s Center for Devices and Radiological Health, provides guidance for determining acceptable practices for the claims, content, and appearance of advertising and promotional materials for medical devices. In the course of doing so, he discusses important regulatory and legal precedents, and provides examples of successful and problematic advertising and promotion strategies including those that resulted in FDA Warning Letters, enforcement activities, and in some cases, monetary and criminal penalties.

PMID: 17002234 [PubMed - indexed for MEDLINE]

Making sense of the Food and Drug Administration.

Semin Pediatr Surg. 2006 Nov;15(4):293-301

Authors: Connor JA

An examination of and recommendations regarding the approval process for medical devices are presented. The typical pathways and hurdles laid out by the Federal Food and Drug Administration (FDA) are discussed, and options for marketing and use of medical devices are addressed. The first step in the regulatory process is to establish that the new product is, in fact, a medical device. From there, the appropriate classification and the corresponding level of regulatory control that will be required can be identified. The appropriate marketing application will be submitted and is supported by the data necessary to reasonably assure safety and effectiveness. Once the application is submitted, reviewed, and eventually approved, the manufacturer may legally market and sell the medical device. The active involvement of physicians as advisors and innovators in medical device development is imperative to the successful development of safe and effective medical devices. Physicians also fulfill the important obligation of adverse event reporting with all medical devices that they use. The pediatric physician should additionally be aware of the FDA regulations and expectations with respect to devices that will serve pediatric patient populations, of the regulatory options for approval and unapproved use for some devices, and of the special measures taken to protect the rights, safety, and welfare of pediatric patients participating in investigational studies.

PMID: 17055960 [PubMed - in process]

[The registration of false teeth and the others]

Zhongguo Yi Liao Qi Xie Za Zhi. 2006 Jul;30(4):302-3

Authors: Huang YW

The quality control of false teeth should include the control for designing and processing. The registration of false teeth should emphasize particularly on the qualification of the makers, technology management, quality control and the labeling.

PMID: 17039946 [PubMed - in process]

Experiences of new product development in the medical device industry.

Med Device Technol. 2006 Apr;17(3):20-2

Authors: Dixon D, Brown A, Meenan BJ, Eatock J

A survey of medical device professionals has revealed the factors that influence the development time and market success of new products. The vital elements that deliver commercial success are reported here.

PMID: 16736659 [PubMed - indexed for MEDLINE]

[A testing method of assessing the protein-removing effect of the contact lenses’ protein -removing care solution]

Zhongguo Yi Liao Qi Xie Za Zhi. 2006 Mar;30(2):131-3

Authors: Wen Y, Jia XH, He T

OBJECTIVE: Testing the protein-removing effect of the protein-removing care solution on the protein precipitation of the soft contact lenses. METHOD: Soak the lenses into the artificial-tears to simulate the protein absorption, test the absorbency of cleaned protein at the wavelength of 280 nm by UV spectrophotometer, and compute the percentage of protein. RESULT: Testing results of the percentage of the cleaned protein are repeatable. CONCLUSION: This experimental method can be used to evaluate the cleaning effect of the protein- removing care solution, but still needs much improvements.

PMID: 16830809 [PubMed - in process]

[Studies on administration of in-vitro diagnostic reagents]

Zhongguo Yi Liao Qi Xie Za Zhi. 2005 Mar;29(2):124-30

Authors: Wang Z, Qian H, Xu FL, Huang JH, Gu WK

This article introduces the definition, classification, premarket admission and other administering specialities about In-Vitro Diagnostic Reagents in the U.S.A. and China. And by analyzing manufacture and administration of In-Vitro Diagnostic Reagents in our country, It is pointed out that a suitable administering model in accordance with the characteristics of In-Vitro Diagnostic Reagents should be adopted to perfect the administration.

PMID: 16011119 [PubMed - indexed for MEDLINE]

Related Articles

Comparison of the physical and mechanical properties of MTA and portland cement.

J Endod. 2006 Mar;32(3):193-7

Authors: Islam I, Chng HK, Yap AU

This study evaluated and compared the pH, radiopacity, setting time, solubility, dimensional change, and compressive strength of ProRoot MTA (PMTA), ProRoot MTA (tooth colored formula) (WMTA), white Portland cement (WP), and ordinary Portland cement (OP). The results showed that PMTA and Portland cement have very similar physical properties. However, the radiopacity of Portland cement is much lower than that of PMTA. The compressive strength of PMTA was greater than Portland cement at 28 days. The major constituent of PMTA is Portland cement. Given the low cost of Portland cement and similar properties when compared to PMTA, it is reasonable to consider Portland cement as a possible substitute for PMTA in endodontic applications. However, industrially manufactured Portland cement is not approved currently for use in the United States and therefore no clinical recommendation can be made for its use in the human body. Further in vitro and in vivo tests, especially with regards its biocompatibility, should be conducted to ascertain if it meets the FDA requirements for use as a medical device.

PMID: 16500224 [PubMed - indexed for MEDLINE]

Devising new tactics. Providers and medical device manufacturers struggle to find best ways to work together on recalls, advisories.

Mod Healthc. 2006 May 8;36(19):24-6

Authors: Mantone J

PMID: 16711236 [PubMed - indexed for MEDLINE]

Poly-L-lactic acid: an overview.

J Drugs Dermatol. 2006 May;5(5):436-40

Authors: Simamora P, Chern W

In August 2004, the US Food and Drug Administration approved a poly-L-lactic acid (PLLA)-based injectable medical device for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. As a result, the properties of the PLLA microparticles have received considerable interest from the medical community. Polylactides have a long-standing history of safe use in medical applications, such as pins, plates, screws, intra-bone and soft-tissue implants, and as vectors for sustained release of bioactive compounds. The L-isomer of polylactic acid is a biodegradable, biocompatible, biologically inert, synthetic polymer. Putatively, PLLA microparticles initiate neocollagenesis as a result of a normal foreign-body reaction to their presence. The build-up of collagen over time creates volume at the site of injection, while the PLLA microparticles are metabolized to carbon dioxide and water and expelled through the respiratory system.

PMID: 16703779 [PubMed - in process]

MEDICAL DEVICES: Promoting a safe Migration Into the Home.

Home Healthc Nurse. 2006 May;24(5):298-304

Authors: Weick-Brady MD, Lazerow RN

Medical device use in the home environment has grown in volume and complexity. Because of this, the Food and Drug Administration (FDA) needs to ensure that these products are safe and effective for use in this environment. The FDA must develop a partnership with home healthcare providers in areas of patient education, monitoring device adverse events that occur in the home environment, and communicating problems to the manufacturer.

PMID: 16699341 [PubMed - as supplied by publisher]

Recommendations for evaluating the validity of quality of life claims for labeling and promotion.

Value Health. 1999 Mar;2(2):113-27

Authors: Leidy NK, Revicki DA, Genesté B

The pharmaceutical industry, the medical device industry, and national regulatory agencies such as the United States Food and Drug Administration (FDA) are faced with a number of difficult issues related to the development and evaluation of health-related quality of life (HRQL) claims for product labeling and promotion. This paper outlines some of the unique challenges of HRQL research and makes recommendations for assuring that claims are based on the results of rigorous studies designed and conducted according to accepted scientific principles and practices. Standards of evidence for HRQL are discussed in terms of research design and methodology, instrumentation, statistical analysis, and interpretation. Examples are provided to highlight important points. The paper concludes with a brief discussion of future trends in HRQL outcomes evaluation.

PMID: 16674343 [PubMed - in process]

Mechanical Devices and US Food and Drug Administration (FDA) Approval.

Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2006;9:123-7

Authors: Reitz BA

Long-term ventricular assist devices for adults have advanced far more than have suitable devices for neonates and infants. The difficulties of design and construction of miniaturized blood pumping systems and the high costs associated with developing, testing, and approval of such devices has been prohibitive. Still, there is an important clinical need for such devices as the availability of donor hearts for this age group has been especially limited. Recently, several pneumatic pulsatile pumps have been developed based on the adult experience, and the issues of regulatory approval are now assuming greater importance for these devices. This chapter reviews the current system for medical device classification and the approval processes in the United States and in Europe. This system is continually evolving, with dedicated and knowledgeable professionals charged with assuring the efficacy, safety, appropriate labeling, and continuing surveillance of approved devices. Pediatric cardiac surgeons involved in transplantation and assist devices need to be aware of the regulatory issues, and work with manufacturers and governmental agencies to make sure that successful devices are available as soon as possible for their patients.

PMID: 16638557 [PubMed - in process]

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Related Articles

Medical device oversight under scrutiny.

JAMA. 2006 Mar 8;295(10):1109-10

Authors: Mitka M

PMID: 16522824 [PubMed - indexed for MEDLINE]

Prediction of specific absorption rate in mother and fetus associated with MRI examinations during pregnancy.

Magn Reson Med. 2006 Feb 28;

Authors: Hand JW, Li Y, Thomas EL, Rutherford MA, Hajnal JV

There is uncertainty regarding the risk posed by magnetic resonance imaging (MRI) examinations to pregnant patients. The most frequently used methods, such as single-shot fast spin echo (ssFSE), often require operation at the specific absorption rate (SAR) limits imposed by safety guidelines. With the introduction of higher-field systems, such limits will be even more significant for fetal imaging. An electromagnetic solver based on the time domain finite integration technique (FIT) was used to predict SAR in an anatomically realistic model of a pregnant patient (28 weeks’ gestation) associated with the radiofrequency (RF) fields from birdcage body coils typical of 1.5 T and 3 T MRI systems (i.e., operating at approximately 64 and 127 MHz, respectively). The results suggest that 1) the highest local SAR is in the mother, with the fetus being exposed to a peak of approximately 40-60% of that value at 64 MHz, increasing to approximately 50-70% at 127 MHz; 2) compliance with U.S. Food and Drug Administration (FDA) and International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines requires control of SAR values averaged over 1 g or 10 g of tissue, respectively; and 3) compliance with Medical Device Agency (MDA) guidelines requires control of the maximum SAR(10g) within the fetus. Magn Reson Med, 2006. (c) 2006 Wiley-Liss, Inc.

PMID: 16508913 [PubMed - as supplied by publisher]