Archive for August, 2008
FDA 510k Web Info
FDA’s website information:
FDA 510(k)s
- General Information
- Federal Register Notices
- Search the Releasable 510(k) Database
- Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered
- Downloadable 510(k) Files
General Info
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Notices
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Search the 510(k) database
You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format :
Device Classification Name:
Regulation Number:
510(k) Number:
Device Name:
Applicant:
Contact:
Product Code:
Date Received:
Decision Date:
Decision:
Classification Advisory Committee:
Review Advisory Committee:
Summary or Statement
- SUMMARY indicates that a summary of safety and effectiveness information is available from FDA
- STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant
Tags: fda 510k
FDA 510k Clearance
For those who may have some confusion on the matter of obtaining FDA 510(k) Clearance, please review the following:
Clearance Requirements
These requirements apply to medical devices classified as Class II or Class III, a 510K clearance is necessary in order to market the product in the US. The clearance requires compliance to the CFR, Part 820 Quality System Regulations (QSRs), Good Manufacturing Practices (GMP) and the other applicable CFRs for the product type and indications for use. 510k Assessments can assist in the preparation and filing the 510K clearance application, provide training on the GMPs, and the implementation of a quality management system in compliance with the QSRs and applicable CFRs.
NOTE: Registrars and notified bodies sometimes offer a different service called “FDA 510k Reviews”. This service is limited to a review of the final draft of the submittal to the FDA. They in NO WAY are allowed to assist or advise you on the how to prepare your submittal, nor provide training or consulting. Our services include assistance in establishing AND final review of the 510k submittal, along with any training or implementation consulting that may be necessary.
Process for Submission
Here are some important facts about this process:
1/ Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. A registration fee is under consideration by Congress.
2/ A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
3/ A 510k requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
4/ The holder of a 510k must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510k.
5/ Please note that the FDA does not perform 510k pre-clearance facility inspections. The submitter may market the device immediately after 510k clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510k
6/ The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.
7/ The FDA charges a one-time fee to review your 510k application. This FDA fee was$4,158 through September 30, 2007. There is a discount available to US companies with under $100,000,000 in sales.
Good Manufacturing Practice Regulations (GMP)
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and Efor drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
For more details on GMP, please visit: What is GMP?
Regulatory Compliance
The following is an excerpt from a treatise on the subject; It’s mostly academic, but a very helpful read.
FDA Regulatory Compliance Reconsidered
Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA’s regulatory power has expanded systematically, albeit gradually, while legislatures and courts in the fifty American jurisdictions broadened liability exposure for manufacturers that sold defective products that injured consumers. Observers have recently criticized the agency for overseeing pharmaceuticals too leniently, even as states increasingly narrowed manufacturers’ liability exposure. For instance, numerous jurisdictions have elevated burdens of proof and circumscribed damage awards.
Substantially less clear is the relationship between FDA regulation and the products liability cause of action. Conventional wisdom holds that agency mandates and common law suits occupy distinct, albeit intersecting, universes. Comparatively few legislative and judicial bodies in the states assign great relevance to defendants’ conformity with regulation, and only a small number expressly apply a “regulatory compliance defense.” However, scrutiny reveals that more jurisdictions address conformity in ways that profoundly, yet subtly, affect the cause of action. Because compliance and the defense have significant effects on personal injury litigation, they require evaluation, which this Article undertakes.
Part I provides an overview of this Article’s scope. Part II then descriptively analyzes the origins and expansion of FDA regulation. Part III details the weight legislatures and courts have traditionally accorded compliance and the increasing relevance that both assign to the concept, ascertaining that a growing number of states make conformity a factor that limits defendants’ liability exposure. Part IV next reviews whether the disadvantages of this phenomenon outweigh the benefits and finds that they do. This Article concludes by proffering suggestions that recognize the compelling societal value of drugs, the importance of uniform manufacturer regulation, and the acute need for the essentially individualized patient consideration that common law suits afford.
For the complete disertation on this subject, please vist: FDA Regulatory Compliance Reconsidered
Certification
PMA Approval, Certification, and other requirements are too involved to share here. For FDA Guidelines, please visit: Guidance for Industry and FDA - Regulation of Medical Devices, or for an earlier article on our sight on the subject of Certification and Approval, please visit: PMA Approval.
Tags: fda 510k clearance
Scientists Overcome Nanotech Hurdle
Article Date: 15 Aug 2008 - 2:00 PDT
When you make a new material on a nanoscale how can you see what you have made? A team lead by a Biotechnology and Biological Sciences research Council (BBSRC) fellow has made a significant step toward overcoming this major challenge faced by nanotechnology scientists. With new research published in ChemBioChem, the team from the University of Liverpool, The School of Pharmacy (University of London) and the University of Leeds, show that they have developed a technique to examine tiny protein molecules called peptides on the surface of a gold nanoparticle. This is the first time scientists have been able to build a detailed picture of self-assembled peptides on a nanoparticle and it offers the promise of new ways to design and manufacture novel materials on the tiniest scale - one of the key aims of nanoscience.
Engineering new materials through assembly of complex, but tiny, components is difficult for scientists. However, nature has become adept at engineering nanoscale building blocks, e.g. proteins and RNA. These are able to form dynamic and efficient nanomachines such as the cell’s protein assembly machine (the ribosome) and minute motors used for swimming by bacteria. The BBSRC-funded team, led by Dr Raphaël Lévy, has borrowed from nature, developing a way of constructing complex nanoscale building blocks through initiating self-assembly of peptides on the surface of a metal nanoparticle. Whilst this approach can provide a massive number and diversity of new materials relatively easily, the challenge is to be able to examine the structure of the material.
Using a chemistry-based approach and computer modelling, Dr Lévy has been able to measure the distance between the peptides where they sit assembled on the gold nanoparticle. The technique exploits the ability to distinguish between two types of connection or ‘cross-link’ - one that joins different parts of the same molecule (intramolecular), and another that joins together two separate molecules (intermolecular). As two peptides get closer together there is a transition between the two different types of connection. Computer simulations allow the scientists to measure the distance at which this transition occurs, and therefore to apply it as a sort of molecular ruler. Information obtained through this combination of chemistry and computer molecular dynamics shows that the interactions between peptides leads to a nanoparticle that is relatively organized, but not uniform. This is the first time it has been possible to measure distances between peptides on a nanoparticle and the first time computer simulations have been used to model a single layer of self-assembled peptides.
Dr Lévy said: “As nanotechnology scientists we face a challenge similar to the one faced by structural biologists half a century ago: determining the structure with atomic scale precision of a whole range of nanoscale materials. By using a combination of chemistry and computer simulation we have been able to demonstrate a method by which we can start to see what is going on at the nanoscale.
“If we can understand how peptides self-assemble at the surface of a nanoparticle, we can open up a route towards the design and synthesis of nanoparticles that have complex surfaces. These particles could find applications in the biomedical sciences, for example to deliver drugs to a particular target in the body, or to design sensitive diagnostic tests. In the longer term, these particles could also find applications in new generations of electronic components.”
Professor Nigel Brown, BBSRC Director of Science and Technology, said: “Bionanotechnology holds great promise for the future. We may be able to create stronger, lighter and more durable materials, or new medical applications. Basic science and techniques for working at the nanoscale are providing the understanding that will permit future such applications of bionanotechnology.”
Biotechnology and Biological Sciences Research Council
Article Source: Medical News Today
Tags: nanotech