Regulatory approval of new medical devices: cross sectional study (scientific article)

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

Q51813698

Regulating incremental innovation in medical devices.

Q53450025

Evaluation and stages of surgical innovations

Q57286518

Translation of highly promising basic science research into clinical applications

Q73352986

Medicine. Life cycle of translational research for medical interventions

Q81931928

The regulation of medical devices

Q84102595

Medical device recalls and transparency in the UK

Q84102610

Creating a space for innovative device development

Q85604903

Postmarket surveillance for medical devices: America's new strategy

Q87434814

Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices

Q28248820

Medical device recalls and the FDA approval process

Q28305384

Challenges in evaluating surgical innovation

Q33793659

Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies

Q34157467

Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports

Q35716074

IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage

Q36937308

IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages

Q36937313

IDEAL framework for surgical innovation 1: the idea and development stages

Q36937320

Translational research: understanding the continuum from bench to bedside

Q37819071

Making the Leap: the Translation of Innovative Surgical Devices From the Laboratory to the Operating Room.

Q38685840

Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland

Q42611446

No surgical innovation without evaluation: the IDEAL recommendations

Q43510923

Robotic surgery: revisiting "no innovation without evaluation".

Q44640763

P275

Creative Commons Attribution

copyrighted

language of work or name

English

Q1860

P921

main subject

medical device

Q6554101

biomedical investigative technique

Q66648976

P304

page(s)

i2587

P577

publication date

2016-01-01

2016-05-20

P1433

published in

The BMJ

Q546003

P1476

title

Regulatory approval of new medical devices: cross sectional study

P478

volume

353

Reverse relations

cites work (P2860)

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