Search Results for AdvaMed

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House Committee Considers Four Device Bills to Add to User Fee Reauthorization By Zachary Brennan - Published 02 May 2017

The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: medical device inspections, FDA inspections, hearing aids, OTC hearing aids, MITA, AdvaMed, contrast agents

BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: BIO, AdvaMed, combination product guidance, pre-RFD program

AdvaMed CEO Confident of Device Tax Repeal This Year By Michael Mezher - Published 11 April 2017

The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: AdvaMed, Medical Device Tax, Inspections

Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs By Zachary Brennan - Published 04 April 2017

Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: user fees, PDUFA, BsUFA, MDUFA, GDUFA, AdvaMed, BIO, AAM

AdvaMed Boils Down Top Priority FDA Guidance Documents for 2017 By Zachary Brennan - Published 09 March 2017

Medical device industry group AdvaMed pointed to seven guidance documents slated for release in 2017 by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health as those that are of the highest priority to its member companies.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: AdvaMed, device guidance, FDA guidance 2017

Industry Group Links More Than 28,000 Job Losses to Device Tax By Zachary Brennan - Published 08 February 2017

As part of its push to fully repeal the medical device tax from the Affordable Care Act, industry group AdvaMed took to the offensive on Wednesday, saying US medical technology jobs declined by more than 28,000 (7.2%) while the 2.3% tax was in effect.

Categories: News, US, Government affairs, In vitro diagnostics, Medical Devices

Tags: medical technology jobs, AdvaMed, device tax

Industry Argues Against FDA Home-Use Device Label Database By Michael Mezher - Published 27 January 2017

The Advanced Medical Technology Association (AdvaMed) is at odds with a recent proposal by the US Food and Drug Administration (FDA) to create a public facing electronic database for home-use medical device labels.

Categories: News, US, FDA, Labeling, Medical Devices

Tags: AdvaMed, Home-use medical devices

AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices By Zachary Brennan - Published 27 September 2016

Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Pfizer, AdvaMed, benefit-risk guidance for medical devices, FDA draft guidance

Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs

Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals? By Zachary Brennan - Published 01 April 2016

Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated.

Categories: News, US, FDA, Clinical, Medical Devices, Postmarket surveillance

Tags: emerging device safety signals, AdvaMed, MDMA, GE, Merck, Novo Nordisk

MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal By Zachary Brennan - Published 26 February 2016

Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA).

Categories: News, US, CDRH, Government affairs, Medical Devices, Preclinical

Tags: MDUFA, user fee reauthorization, MITA, AdvaMed, ODE, new CDRH hires

MDUFA IV Negotiations: FDA, Industry Propose New Performance Goals By Zachary Brennan - Published 10 December 2015

At the November meeting on the fourth iteration of the Medical Device User Fee Act (MDUFA IV), the US Food and Drug Administration (FDA) and industry representatives both unveiled new performance targets for de novo submissions, pre-submissions and third-party 510(k) reviews.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Postmarket surveillance, Preclinical, Quality, Reimbursement

Tags: MDMA, MITA, AdvaMed, medical device, MDUFA, FDA user fees

Industry Weighs Integration of UDIs Into Medical Device Registry Network By Michael Mezher - Published 18 November 2015

The Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: Coordinated registry networks, CRN, Medical Device Registry Task Force (MDRTF), AdvaMed, Pew Charitable Trusts, Unique Device Identification, UDI

FDA, Industry See Progress in MDUFA IV Negotiations By Zachary Brennan - Published 30 October 2015

At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction.

Categories: Business Skills, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDUFA IV, user fees, IDEs, Q-submissions, MDMA, MITA, AdvaMed, ACLA, Booz Allen

FDA Commissioner Outlines Critical Time Ahead for Agency By Zachary Brennan - Published 27 October 2015

As the US Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for new major legislation overhauling parts of its operations, a major transformation is in the works over the next couple of years.

Categories: News, US, FDA, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA, Ostroff, FDA Commissioner, user fees, AdvaMed

Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation By Alexander Gaffney, RAC - Published 11 February 2015

The US's largest medical device trade group, AdvaMed, has unveiled a new "Innovation Agenda" it hopes will complement legislative efforts meant to improve the way in which the US Food and Drug Administration (FDA) regulates medical devices.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Submission and registration

Tags: AdvaMed, Innovation Agenda, 21st Century Cures Act, 21st Century Cures Initiative

AdvaMed Outlines Wishlist for New Changes to 510(k) Process By Alexander Gaffney, RF News Editor - Published 14 June 2013

Categories: US

Tags: AdvaMed, Latest News, 510(k), White Paper, guidance, medical device

Medical Device Industry Comes Together to Slam Proposed Regulation on Clinical Trials By Alexander Gaffney, RF News Editor - Published 31 May 2013

Categories: US, FDA

Tags: Clinical Research, AdvaMed, harmonization, regulation, clinical trials, medical device

AdvaMed to FDA: Finish Social Media Guidance, Narrow Focus on New Guidance Documents By Alexander Gaffney, RF News Editor - Published 11 March 2013

Categories: FDA, CDRH

Tags: AdvaMed, Latest News, draft guidance, guidance, medical device

Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA By Alexander Gaffney - Published 28 March 2012

Categories: FDA, CDER, CDRH

Tags: BIO, Pew, Testimony, Shuren, GPhA, Woodcock, PhRMA, AdvaMed, Latest News, HELP, Congress, committee

FDA Calls for Proposed Industry Labeling Standards By Alexander Gaffney - Published 29 February 2012

Categories: FDA, CDRH, Labeling

Tags: Standardized, Poll, AdvaMed, Survey, Latest News, label, study, medical device

Hoping to Relax Regulatory Burdens, Medical Device Manufacturers Gain Clout on the Hill By Alexander Gaffney - Published 27 February 2012

Categories: FDA, CDRH

Tags: Clout, Influence, Shuren, IOM, AdvaMed, Latest News, Bill, Congress, Political

Bloomberg: French Breast Implant Scandal May Alter US Medical Device Regulation Debate By Alexander Gaffney - Published 19 January 2012

Categories: EC, EMA, FDA

Tags: AdvaMed, MDUFA, Scandal, Breast Implant, PIP, Latest News, medical device