Aaron is based in our Washington, DC office and is a Senior Director of ML Strategies. He advises clients on health care policy issues related to medical devices and pharmaceuticals.
Prior to joining ML Strategies, Aaron spent 10 years with the US Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health where he led legislative policy development activities related to all aspects of medical device regulation and oversight. He also apprised members of Congress and their staffs about FDA policies and programs and advised multiple FDA Commissioners and other senior officials on strategy and content for meetings with Congress, industry representatives, and other stakeholders. In addition to negotiating the reauthorization of the medical device user fee program (MDUFA), Aaron led FDA’s implementation of key provisions of the 21st Century Cures Act and the FDA Reauthorization Act.
Earlier, Aaron was a budget analyst in the FDA’s Center for Drug Evaluation and Research, where he developed the center’s annual budget and provided information to the Congressional Budget Office (CBO) and congressional authorizers. He began his FDA career in the Center for Biologics Evaluation and Research as an information management specialist responsible for data analyses to support FDA policies and programs.
During his tenure with the FDA, Aaron won numerous agency awards, including the Lireka P. Joseph Award for Excellence in Public Health Communication or Education. He also received special recognition from multiple FDA Commissioners, including a June 2017 special citation for outstanding and sustained performance in the negotiation and reauthorization of MDUFA IV and an August 2016 award for contributions to the 21st Century Cures Act.
Aaron earned a master’s certificate in project management from the George Washington University School of Business and is certified by the American Society for Quality as a quality improvement associate.
Education
- Johns Hopkins University (MS)
- University of Virginia (BA)
Recent Insights
Viewpoints
Device Modernization Series: In Vitro Clinical Tests
March 7, 2019|Blog
What to Expect at FDA Following Commissioner Gottlieb's Departure
March 6, 2019|Blog
News & Press
On June 12, MedCityNews published an article authored by Senior Director of ML Strategies Aaron Josephson addressing challenges faced by the U.S. Food and Drug Administration (FDA)’s Pre-Certification (“Pre-Cert”) program. The Pre-Cert program would revolutionize regulation and oversight of certain medical devices.
In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”
In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”
Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests. The groups have different views on FDA’s purview, but they generally agree that diagnostic tests should be regulated differently than traditional medical devices. ML Strategies Senior Director Aaron Josephson talks about this latest draft of the bill.
Events
The adoption of connected medical devices and the Internet of Medical Things (IoMT) has both enhanced the quality of patient care and increased the vulnerability of health care organizations. Sophisticated cyberattacks on hospitals and health systems threaten patient safety and impose substantial financial costs. Join ML Strategies, Mintz, and Zingbox for a discussion on the policy and operational challenges for health care organizations and recommendations for accelerating the public and private response.
Share in discussions with Suzanne Schwartz, Acting Deputy Center Director for Science at the FDA’s Center for Devices & Radiological Health, Chief Information Security Officers (CISOs) from leading hospitals, and experienced security colleagues on the current landscape, strategic goals, and lessons learned from their own organization’s medical device security journey.
Share in discussions with Suzanne Schwartz, Acting Deputy Center Director for Science at the FDA’s Center for Devices & Radiological Health, Chief Information Security Officers (CISOs) from leading hospitals, and experienced security colleagues on the current landscape, strategic goals, and lessons learned from their own organization’s medical device security journey.
Viewpoints
FDA Silent on CBD Regulation at Cosmetics Conference, But Legislation May Be Imminent
April 1, 2019 | Blog | By Benjamin Zegarelli, Aaron Josephson
Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite answers were in short supply due to the current confusion over the legality of CBD as a product itself or other products, such as food or cosmetics, with CBD added.
When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CDB advice to share with industry attendees.
When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CDB advice to share with industry attendees.
Device Modernization Series: In Vitro Clinical Tests
March 7, 2019 | Blog | By Aaron Josephson
In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory developed tests (LDTs) and other in vitro diagnostics (IVDs). The proposed approach would create an entirely new category of medical product separate from medical devices known as in vitro clinical tests (IVCTs).
What to Expect at FDA Following Commissioner Gottlieb's Departure
March 6, 2019 | Blog | By Aaron Josephson
On March 5, 2019, FDA Commissioner Scott Gottlieb announced his resignation. The physician and venture capitalist, for whom this was a second stint at the FDA, intends to leave the agency in about a month to spend more time with his family. In this post, Aaron Josephson reflects on Dr. Gottlieb's time leading the FDA and its future after his departure.
Device Modernization Series: FDA’s Proposed De Novo Regulation
February 28, 2019 | Blog | By Aaron Josephson
In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program. FDA also recently issued a proposed regulation for the De Novo program and linked that proposed regulation to 510(k) modernization efforts as part of a broader strategy to improve device safety.
The proposed De Novo regulation, issued December 5, 2018, would codify into regulation many of the policy and programmatic features of the De Novo program that are currently outlined in guidance documents. Because guidance is nonbinding, FDA is seeking through the proposed regulation to provide structure, clarity, and transparency to the De Novo process in a way that would be binding on De Novo submitters.
The proposed De Novo regulation, issued December 5, 2018, would codify into regulation many of the policy and programmatic features of the De Novo program that are currently outlined in guidance documents. Because guidance is nonbinding, FDA is seeking through the proposed regulation to provide structure, clarity, and transparency to the De Novo process in a way that would be binding on De Novo submitters.
Device Modernization Series: FDA’s Changes to the 510(k) Program
February 21, 2019 | Blog | By Aaron Josephson
In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program as it has existed since the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. The 510(k) pathway has been scrutinized for years and among the most damning criticisms leveled against it is that it is a loophole that lets unsafe products on the market by allowing manufacturers to, in most cases, avoid clinical testing. As long as the Federal Food, Drug, and Cosmetic Act allows for 510(k)s, though, FDA has to make the review program work, so the agency is looking for ways to improve the safety of 510(k)-cleared devices rather than burying its head in the sand.
FDA 2018 Year in Review (and a Few Thoughts on 2019)
December 27, 2018 | Blog | By Joanne Hawana, Bethany Hills, Aaron Josephson, Benjamin Zegarelli
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs point to yes” that everything on the list below will continue to be major areas of focus for both FDA and the U.S. Congress next year and into the foreseeable future.
Observations from FDA’s Public Workshop on Medical Device Servicing and Remanufacturing
December 19, 2018 | Blog | By Benjamin Zegarelli, Aaron Josephson
On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from remanufacturing. FDA expressed intent to develop a draft guidance on this topic as part of its May 15, 2018 report to Congress on the quality, safety, and effectiveness of medical device servicing. This post provides some observations about areas of agreement among stakeholders and FDA’s perspective on servicing versus remanufacturing.
Paradigm Shift: Regulating Software as a Medical Device in the U.S.
December 19, 2018 | Blog | By Aaron Josephson
The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety and effectiveness. SaMD is software used for a medical purpose that is not part of a hardware medical device. The new approach is known familiarly as Pre-Cert and relies on a company being certified by FDA as having a culture of quality and organizational excellence.
Medical Products & FDA: What to Watch for in 2019
December 4, 2018 | Blog | By Aaron Josephson
Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar spent on products ranging from heart valves to insulin to breakfast cereal, so there’s always something Congress can do in the realm of FDA’s statutory authorities. Many FDA-related bills are often bipartisan, too, which suggests action regardless of which party is in power. Here are a few key medical product issues we’ll be tracking in 2019.
FDA’s Refreshed Approach to Device Safety Would Require Major Changes to 510(k) Program
November 27, 2018 | Blog | By Aaron Josephson
On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety. The 510(k) program relies on a device being compared to a legally marketed predicate device; i.e., a similar device that was already determined to be legally marketable.
News & Press
Senior Director of ML Strategies Authors Article Published by MedCityNews on FDA’s Pre-Cert Program
June 12, 2019 | MedCityNews
On June 12, MedCityNews published an article authored by Senior Director of ML Strategies Aaron Josephson addressing challenges faced by the U.S. Food and Drug Administration (FDA)’s Pre-Certification (“Pre-Cert”) program. The Pre-Cert program would revolutionize regulation and oversight of certain medical devices.
In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”
In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”
Patients, Test Makers Ask Lawmakers To Meet On Diagnostics Bill Draft
May 8, 2019 | Inside Health Policy
Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests. The groups have different views on FDA’s purview, but they generally agree that diagnostic tests should be regulated differently than traditional medical devices. ML Strategies Senior Director Aaron Josephson talks about this latest draft of the bill.
Regulatory Experts: OMB Memo Could Drastically Slow FDA Guidances
April 15, 2019 | InsideHealthPolicy.com
ML Strategies Senior Director Aaron Josephson is featured in this article, which discusses a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress – that could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.
FDA Accepts Feedback On VALID, Clinical Lab Test Lobby Encouraged
March 28, 2019 | Inside Healthy Policy
This article explores American Clinical Laboratory Association (ACLA) president and CEO Julie Khani’s desire to start a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics. Specifically, she hopes to work with the agency on revisions to the bill's provision involving precertification and modification of existing tests in order to make those concepts less burdensome for test makers. Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, is among the industry sources quoted within the piece.
Device Experts: Pre-Cert, 510(k) Reforms Unaffected By Gottlieb Departure
March 9, 2019 | Inside Health Policy
FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are quoted in this article discussing how the FDA’s big-ticket medical device reform initiatives, such as medical software precertification, 510(k) predicate reform and changes to the de novo process likely will continue to develop as planned even as FDA Commissioner Scott Gottlieb, who has drawn attention to such efforts throughout his two-year tenure as agency chief, is due to resign in one month.
Former FDA Advisor: Abernethy Could Be Next In Line To Lead FDA
March 7, 2019 | Inside Health Policy
FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are quoted in this article discussing the possibility of FDA Principal Deputy Commissioner Amy Abernethy filling in as acting FDA commissioner, or possibly even succeed FDA Commissioner Scott Gottlieb when the current commissioner leaves the agency in a month.
Experts Disagree Over Whether FDA Has Authority For Pre-Cert
January 10, 2019 | Inside Health Policy
This feature article discusses the industry’s reaction to the Food & Drug Administration’s (FDA) newly-released information on their medical software precertification program. The article notes that initial reactions are split regarding an important question – If the FDA has statutory authority to implement pre-certification. Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, is among the industry sources quoted within the piece.
FDA Clarifies Breakthrough Device Pathway, Safer Tech Program
December 18, 2018 | Inside Health Policy
FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are featured in this article discussing two recently-announced actions by the Food & Drug Administration (FDA) to encourage industry adoption of two accelerated review and development pathways for new devices. The FDA’s announcement centered upon a final guidance on the breakthrough devices pathway and recommendations for a new Safer Technologies Program (STeP).
'Reined-In' US Diagnostics Legislation Adds Pre-Certification, Other Updates
December 12, 2018 | Medtech Insight
This feature story looks at a new revised bill focused on the Food & Drug Administration’s (FDA) regulation of diagnostics. The piece notes that the bill, currently being reviewed by members of Congress, would provide a great number of updates including the ability for FDA to leverage a pre-certification process to validate test developers. ML Strategies Senior Director Aaron Josephson is among the industry sources providing commentary in the piece.
Device Expert: FDA De Novo Rule Provides Clarity For Industry
December 5, 2018 | Inside Health Policy
Aaron Josephson, ML Strategies Senior Director who previously worked for the Food & Drug Administration (FDA), discusses the FDA's proposed rule on the de novo pathway. Aaron notes that this could provide necessary clarity for device manufacturers, modernize the 510(k) premarket notification process and help the FDA achieve the performance goals laid out by Congress.
Medical Device Expert: FDA Report Responds To Enforcement Criticism
November 29, 2018 | Inside Health Policy
ML Strategies Senior Director Aaron Josephson, a former FDA senior policy advisor, is quoted in this feature story that looks at claims made that the FDA's Medical Device Enforcement and Quality Report was released in an effort to silence criticism that the FDA does not take sufficient enforcement action when appropriate.
FDA’s Move To Publish Names Of Devices With Old Predicates As Part Of 510K Reform Shocks Industry
November 27, 2018 | Inside Health Policy
In an effort to modernize and tighten its medical device clearance process, the Food & Drug Administration (FDA) announced plans to publish the names of devices cleared using predicate devices that are 10 years and older. ML Strategies Senior Director Aaron Josephson, a former FDA Senior Policy Advisor, is among the industry sources quoted in the article providing commentary.
FDA Floats Humane Dog Drug Study, Hopes Industry Will Follow Suit
November 20, 2018 | Inside Health Policy
ML Strategies Senior Director Aaron Josephson is among the industry sources providing commentary in this article on the FDA's proposal to test a minimally invasive dog drug study.
Drug Lawyers: FDA’s Complete Response Letters Are Anything But
November 8, 2018 | Inside Health Policy
This article notes that drug industry lawyers are encouraging the Food & Drug Administration (FDA) to provide specific feedback during new product reviews to drug applicants. The objection to the current process is that it does not address crucial details and makes the process more frustrating and contentious than it should be. Aaron Josephson, Senior Director of ML Strategies who spent 10 years at FDA, is among the industry sources quoted in the article.
Device Experts: Expanded Special 510(k) Good For Software, Review Times
October 2, 2018 | Inside Health Policy
This feature article notes the medical device industry’s reaction to a draft guidance released by FDA aimed at expanding the use of a faster premarket review program could, if finalized, be particularly useful for software companies. The piece further notes that this could help the FDA achieve its goal of reducing its average 510(k) review times. FDA Practice Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are among the industry sources providing commentary.
Events
Panelist
May
21
2019
The Digital Core in Pharma and Personalized Medicine Development
Mintz 3580 Carmel Mountain Road | Suite 300 San Diego, CA 92130
Panelist
May
3
2019
Food and Drug Law Institute Annual Conference
Current Proposals for Diagnostics Reform
Washington, DC
Speaker
Apr
24
2019
Speaker
Apr
16
2019
American Telemedicine 2019 Annual Conference and Expo
FDA's New Approach to Digital Health
Arlington, VA
Speaker
Panelist
Nov
1
2018