Impact Analytical – News

Blog: News / Press Releases
The FDA's agenda on medical device safety, drug prices and vaccines
(December 2, 2018)


FDA to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk

  • The Food and Drug Administration plans to overhaul the 510(k) clearance process for medical devices.
  • FDA Commissioner Scott Gottlieb said the FDA wants to push the medical device market toward new technology.
  • The announcement comes after a consortium of news outlets published investigations into medical device injuries.

The Food and Drug Administration is overhauling the most common way medical device manufacturers bring their products to market in an attempt to advance new technologies.

Since 1976, manufacturers have been able to pursue an expedited approval process if they could prove new products were substantially equivalent to those that were grandfathered in when Congress established the pathway, known as 510(k).

That means some new products entering the market are comparing themselves to technology that's decades old. Now, the FDA wants to retire those predicates, or older base products, which sometimes aren't even on the market anymore, and make it easier for companies to establish new ones, FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health Director Jeff Shuren said in a statement Monday.

The announcement comes after a consortium of news outlets over the weekend published scathing investigations into medical device failures and how the FDA's accelerated review process may have missed problems and put consumers at risk. However, the FDA had planned the changes ahead of the news stories, it said.

"What we want to do is constantly push the market toward incorporating better technology and better capabilities by advancing the predicates and always looking forward so the ... predicates the device companies are using as the basis of their approvals are constantly incorporating newer and better technology to make the devices better and safer," Gottlieb said Monday in an interview with CNBC's Becky Quick.

Gottlieb, a Trump appointee, has pushed regulations that are meant to encourage industry to act. This latest one is no different.

In modernizing the 510(k) approval process, the FDA wants to nudge companies to base new products on devices that are no older than 10 years old. The agency is considering publicizing devices and manufacturers whose products are based on even older technology.

Advanced Medical Technology Association, or AdvaMed, the industry's lobbying group, pushed back.

"The proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices," AdvaMed CEO Scott Whitaker said in a statement.

Last year, the FDA cleared 3,173 devices through this system, or 82 percent of the total devices cleared or approved, Gottlieb and Shuren said in their statement. Nearly 20 percent of products cleared through the 510(k) pathway are based on a predicate device that's more than 10 years old, they said.

The FDA plans to finalize its guidance on establishing an alternative accelerated pathway early next year.

Original website post can be found below.

Mass Spec Interpretation – Art or Science? Jim Via, Ph.D. joins the Impact team.
(April 22, 2018)

Actually, it’s both. But, it all starts with a fundamental understanding of the chemistry of your molecule and your matrix.

Mass spectrometry (MS) is a valuable technique for identifying and quantifying analytes based on their masses, and it can be coupled with various instruments to separate analytes. Whether you are evaluating polymer extractables, pharmaceutical impurities, surfactants, degradation products, or color bodies, mass spectrometry can provide the data, but it takes an expert to understand what you are observing.

At Impact Analytical, we combine our analytical experience with background information of the test material and chemical processes provided by our customers. Having this background information aids in understanding the possible compounds that may observed in the mass spectrum. Add to this, tools such as databases (purchased and homegrown) and accurate mass Q-ToF instrumentation, as well as MS-MS capability for further chemical ion fragmentation, and the chemical formulas that are provided by the instrumentation take on detail that can result in chemical structure elucidation.

Our experienced chemists can help you identify unknown compounds in your matrix, whether it is a polymer additive, an unknown chemical reaction product, or an impurity in your drug substance. For example, a commercial surfactant was submitted for analysis to identify the major surfactant components. Our mass spectroscopists were able to determine that the major components were a mixture of alkyl benzenesulfonates, salts with useful properties as surfactants. From the LC-MS data, and from MS/MS information, it was determined that the alkyl groups consisted of saturated and unsaturated groups, and we were able to provide our customer with chemical structures of eight components. 

As Impact Analytical grows, our extensive interpretation experience remains a principal element in providing excellent results. In order to ensure the satisfaction of both current and new customers, we are proud to announce the addition of a new team member to the Liquid Separations Group. Jim Via, Ph.D. joins Impact with a strong background in LC-MS and GC-MS, as well as experience in polyesters, polyurethanes, ultra-trace analysis of food packaging, and deformulation. With nearly 25 years of experience, Jim is sure to be a valuable asset for our customers.

Contact us to discuss how we can provide the answer to your analytical questions today. 

The Importance of a Quality Management System and Announcing New Quality Assurance Hire.
(March 19, 2018)

At Impact Analytical, we have developed an integrated Quality Management System (QMS) that meets the requirements of FDA-GLP, FDA-cGMP, and EPA-GLP regulatory system elements as well as ISO 9000 certification requirements.

By designing and implementing an integrated QMS, the laboratory has encouraged a culture of quality starting with highly visible management involvement and support, including systems that consistently seek to prevent errors, recognize quality achievements, optimize operations, all ultimately leading to minimal errors in our data and our reports.

The systems and checks we have in place minimize the chances for errors or system failures. If any errors occur, they are detected and corrected early in the process, as well as triggering investigations into the causes of the errors in order to prevent recurrence.

We expect all personnel to participate in decisions about the most appropriate ways to conduct our studies from technical and data quality perspectives. Laboratory personnel participate on a revolving basis in Quality System Audits under the guidance of the QA unit, which gives them a broader understanding of the quality system, and how their activities impact the overall success of the company.

As Impact Analytical grows, quality remains a principal element in providing excellent results. In order to ensure the satisfaction of both current and new customers, we are proud to announce the addition of a new team member to the Quality Assurance Unit. Thomas Buter joins us with a strong background in clinical research and toxicology, as well as a strong reputation as a thorough and professional quality assurance auditor. 

Contact us to discuss how we can provide the answer to your analytical questions today. 

Impact Announces Partnership with E.M.M.A International to Speed Time to Market
(November 1, 2017)

Midland, MI (November 1, 2017) – Impact Analytical, Inc. is excited to announce a strategic alliance with E.M.M.A International. This partnership will aide our common clients in navigating the complicated world of regulatory and quality compliance.

“Time to market is everything for our customers, whether they are a startup medical device manufacturer or a Fortune 500 company. This partnership allows us to accelerate the regulatory approval process by streamlining the analytical data exchange process behind the compliance process. For most customers, this will ultimately translate into lower costs too,” ” said Neil Chapman, Impact Chief Executive Officer. “We’re very appreciative of the E.M.M.A International team for sharing our vision of growth, and the importance of continued outstanding customer service.”

“With this partnership we believe we can help our combined client base increase their profitability through faster, more streamlined processes,” said Carmine Jabri, Chief Executive Officer of E.M.M.A International. “We look forward to enjoying a long term relationship with Impact Analytical.

Launched in 2015, Impact is a fully accredited, independent testing lab providing highly customized service and support to over 300 international customers. Impact is focused on providing best in class service to customers with demanding needs in the Pharmaceutical, Medical Device, Polymer and Specialty Chemical industries. Impact is registered by the FDA and licensed by the DEA along with being accredited to ISO 9001:2015.

Headquartered in Farmington Hills, MI, with offices in Clearwater, FL and York PA the team of experts at E.M.M.A. International ( provide support to clients globally focusing on quality systems, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, Medical Device and all other FDA regulated industries.

Impact Analytical Welcomes New Operations Manager, Ronald Miller
(September 22, 2017)

Impact Analytical welcomes Ron Miller to the organization as Operations Manager for the Midland Michigan facility. Miller brings over 20 years of experience in the field of analytical chemistry most recently as the Senior Scientist for a multinational testing company. He holds a Bachelor’s degree in Chemistry from Wayne State University in Detroit and a Master’s degree in Molecular Biology from Lehigh University in Bethlehem PA. “Mr. Miller is a great addition to our team, bringing with him years of knowledge not only in the field of analytical chemistry but also in the area of client engagement” said Neil Chapman, President of Impact Analytical. In his new role Miller will focus on meeting the needs of our more than 300 clients globally while ensuring the highest quality of service and on time delivery is maintained. Contact us for more information on how we help our clients get their products to market.

Impact Analytical appoints Neil Chapman as its new President
(January 26, 2017)

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